You are on page 1of 8

Clinical Chemistry 47:7 Evidence-based

1204 –1211 (2001) Laboratory Medicine


and Test Utilization

Discontinuation of the Bleeding Time Test without


Detectable Adverse Clinical Impact
Christopher M. Lehman,1,3* Robert C. Blaylock,1,3 Donald P. Alexander,4 and
George M. Rodgers1,2,3

Background: The bleeding time (BT) test predicts a Conclusions: Our study failed to identify a clinically
higher bleeding complication rate in populations at risk significant, negative impact of discontinuing the BT
for inherited or acquired platelet dysfunction, but it is test.
of limited assistance in evaluating individual patients. © 2001 American Association for Clinical Chemistry
There are no reports of clinical outcomes after discon-
tinuation of the BT test. Excessive bleeding may complicate medical procedures
Methods: Interviews with a subset of the physicians when a patient has an acquired or inherited disorder of
who had ordered the BT test before discontinuation of platelet function (1 ). Bleeding time (BT)5 tests were de-
the test were conducted. The total number of platelet- veloped in the hope that quantifying the length of time a
aggregation tests, the mean number of monthly, unmod- patient bled after incising or puncturing the skin would
ified platelet units transfused, the incidence of kidney aid in the diagnosis of platelet dysfunction disorders and
biopsy complications, and the number of doses of would predict the risk of abnormal bleeding from internal
1-deamino-8-D-arginine vasopressin (DDAVP) adminis- organs during and/or after an invasive procedure (2, 3 ).
tered 5 months before and after discontinuation of the Unfortunately, the BT test became popularized in clinical
BT test were compared. We recorded the rates of bleed- practice without sufficient peer-reviewed evidence sup-
ing complications in the Major Surgery Risk Pool dur- porting its use, probably under the assumption that an in
ing the 12 months before and the 5 months after the vivo test was needed and no other test was available. By
discontinuation of the BT test. the early 1990s, sufficient data questioning the utility of
Results: Clinicians reported they did not significantly the BT test as a predictor of clinical bleeding had accu-
change their preprocedural work-ups, postpone an in- mulated to prompt the publication of two review articles
vasive procedure, experience an increase in bleeding opposing routine preoperative use of the BT test, and
complications, or increase their use of blood products suggesting that the BT test might be of limited use under
after discontinuation of the BT test. Platelet-aggregation any circumstances (4, 5 ). The College of American Pathol-
tests (n ⴝ 9, before and after), platelet transfusions (P ⴝ ogists and the American Society of Clinical Pathologists
0.958), and DDAVP administration (before ⴝ 24; after ⴝ later published a position article (6 ) concluding that the
10) did not increase after discontinuation of the BT test. BT test was not effective as a screening test in patients
The rate of postprocedural bleeding complications did lacking a history of excessive bleeding, including patients
not increase significantly in either Major Surgery Risk who had recently taken aspirin or nonsteroidal antiin-
Pool cases (<3␴ deviation from the mean rate) or in flammatory agents (NSAIDs). Nonetheless, the BT test is
patients undergoing renal biopsies (P ⴝ 0.225 for de- still commonly recommended for use in assessing the risk
crease in hematocrit; P ⴝ 1.000 for the percentage of of bleeding in patients taking drugs or herbs or suffering
patients transfused) after discontinuation of the BT test. from inherited or acquired disorders known to adversely
affect platelet function (7–12 ).
In recent years, the frequency in ordering the BT test at
1
our institution had gradually decreased to the point that
Department of Pathology, Division of Clinical Pathology, 2 Department
of Medicine, Division of Hematology, and 4 Department of Pharmacy Services,
its use was confined to patient populations with impend-
University of Utah Health Sciences Center, Salt Lake City, UT 84132.
3
ARUP Laboratories, Inc., 500 Chipeta Way, Salt Lake City, UT 84108.
*Address correspondence to this author at: Department of Pathology,
5
University of Utah Health Sciences Center, 5C124 SOM, 50 N. Medical Drive, Nonstandard abbreviations: BT, bleeding time; NSAID, nonsteroidal
Salt Lake City, UT 84132. Fax 801-585-6666; e-mail lehmanc@arup-lab.com. antiinflammatory agent; BUN, blood urea nitrogen; and DDAVP, 1-deamino-
Received in revised form March 12, 2001; accepted April 5, 2001. 8-d-arginine vasopressin.

1204
Clinical Chemistry 47, No. 7, 2001 1205

ing invasive procedures who were presumed to be at risk


for acquired platelet function disorders. The decreased
volume of testing made it difficult to train new personnel,
to document continuing competency of existing person-
nel, and to perform proficiency testing as required by
good laboratory practice and the Clinical Laboratory
Improvement Act of 1988. Consequently, our Hospital
Laboratory Committee, composed of diverse clinicians
and administrators, reevaluated the efficacy of the BT test
in contemporary clinical practice and decided to discon-
tinue offering the test to our clinicians. Although other
institutions have reportedly limited or eliminated the BT
test (13, 14 ), we are unaware of any reports of clinical
outcomes after discontinuation of the test. This report
summarizes our experiences after removal of the BT test
from the repertoire of clinical laboratory tests at a busy,
tertiary care, university medical center.

Materials and Methods


Clinicians with admitting privileges to the Hospital were
notified by mail of discontinuation of the BT test as
approved by a multidisciplinary Hospital Laboratory
Committee in January 1999. The memo included back-
ground information on the BT test, as well as a discussion
of its limitations and citations of the literature supporting
its discontinuation. An algorithm for evaluating the risk
of a bleeding disorder in patients with a personal or
family history of bleeding (Fig. 1) was also included in the
mailing, along with phone numbers of two physician
laboratorians who were available for consultation. The Fig. 1. Algorithm for evaluating the risk of excessive bleeding in
University of Utah Health Sciences Center is a tertiary patients with a personal or family history of bleeding, which was
care center with active adult Hematology/Oncology, Ne- distributed to clinicians before discontinuation of the BT test.
phrology, Transplant (renal, heart, heart/lung, kidney, PT, prothrombin time; PTT, partial thromboplastin time.
bone marrow), Gastroenterology and Neurosurgery pro-
grams. The Newborn Intensive Care and Well Baby Units during the same 5-month intervals described above were
represent the only pediatric patient care units. The clinical also compared. To assess the potential effect of discontin-
specialties represented on the Hospital Committee at that uation of the BT test on surgical procedures, the summary
time included Family Practice, Hematology, Pulmonary statistics for the overall rate of postprocedural hemor-
Medicine, General Surgery, Obstetrics/Gynecology, An- rhage or hematoma in patients in the Major Surgery Risk
esthesiology, Pathology and Emergency Medicine. Pool (University HealthSystem Consortium Clinical Per-
Indications for platelet transfusions administered to formance Measure 2947) for the 12 months before and the
patients with normal platelet counts in the first 4.5 months 5 months after discontinuation of the BT test were re-
after discontinuation of the BT test were determined by viewed. The Major Surgery Risk Pool consists of 126
reviewing patient medical records. The mean number of surgical procedures including gastrointestinal, cardiovas-
nonirradiated, nonleukocyte-reduced apheresis and cular, oncologic, transplant, urologic, orthopedic, plastic,
pooled platelet units transfused during the 5 months gynecologic, and endocrine procedures. Bleeding compli-
(February 1999 through June 1999) after discontinuation cations are identified by reviewing bleeding-related
of the BT test was compared with the mean number ICD-9 codes reported in association with Major Surgery
transfused in the 5 months immediately before discontin- Risk Pool procedures. Complication rates are calculated
uation of the BT test and with the mean number trans- as the number of patients experiencing postprocedural
fused during the same 5-month interval of the preceding hemorrhage or hematoma divided by all eligible surgical
year (February 1998 through June 1998), using the Student patients. The monthly complication rates were compared
t-test (SPSS 9.0.1; SPSS). The unmodified platelet products through the use of a Shewart control chart for attributes
were chosen for analysis because they would be used for (15 ). Complication rates for the 12 months before and 5
nonimmunosuppressed patients, the primary patient months after discontinuation of the BT test were plotted
population to undergo BT testing at our institution. The on a “fraction-defective” or “P” control chart with stan-
number of platelet-aggregation tests ordered by clinicians dard upper and lower control limits of ⫾ 3␴, based on a
1206 Lehman et al.: Bleeding Time Test

binomial distribution (SPSS 9.0.1). Complication rates


Table 1. Questionnaire used for clinician interviews.
exceeding the mean rate by 3␴ are an indication of a
Non-surgical Services
process that is statistically out of control (15 ).
Has discontinuation of the BT test changed your practice with
To assess the possible impact of discontinuation of the respect to organ biopsy? Assessment of bleeding risk for other
BT test on bleeding complications in a patient population procedures or operations?
known to be predisposed to abnormal platelet function Have you seen an increase in bleeding complications from organ
and who undergo invasive diagnostic procedures, we biopsy (or other procedures) since discontinuation of the BT test?
Subjective? Objective?
chose to evaluate the complication rate of kidney biopsy
Have you changed your pre-biopsy assessment or treatment of
procedures performed during the 5 months immediately patients undergoing biopsy? If so, how?
before and the 5 months immediately after discontinua- Are biopsies being postponed, for lack of the BT result, until
tion of the BT test. Demographic characteristics (age, sex), pharmacologic, transfusion or dialysis therapy is completed? Is
the origin of the biopsied kidney (native vs allograft), and this a change from prior practice?
pertinent laboratory values [prebiopsy BT test, blood urea Surgical Services
nitrogen (BUN), creatinine, hematocrit, platelet count, Has discontinuation of BT test changed your practice with respect to
prothrombin time, partial thromboplastin time, and the pre-surgical assessment of bleeding risk? If so, how?
postbiopsy hematocrit] were summarized for each Postponement of surgery?
5-month interval. The percentage of patients with abnor- Discontinuation of drug affecting platelet function?
mal coagulation values (prothrombin time ⬎15.0 s; partial Dosing of drug to improve platelet function (e.g., steroids,
thromboplastin time ⬎40 s), an abnormally low platelet DDAVP)
Transfusion of platelets, RBC’s or cryoprecipitate prior to
count (⬍140 ⫻ 109/L), or a hematocrit ⬍0.300 (30%) was surgery?
calculated. The incidence of red blood cell transfusions Change in Pre-surgical assessment of risk?
secondary to postbiopsy bleeding, documented by ab- Platelet function assessment?
dominal computed tomography, was also assessed for the Assessment of prior history (personal or family) of bleeding?
two intervals. Continuous variables were tested with the Consult from Hematology or Transfusion Service.
Kolmogorov–Smirnov test to determine whether ob- Have you seen an increase in bleeding complications since
served values came from a gaussian distribution. All discontinuation of the BT test? Subjective? Objective?
variables followed a gaussian distribution except for Have you increased your use of blood products since
creatinine and BUN. Mean values were compared using discontinuation of the BT test?
the two-sided Student t-test. Median values were com-
pared using the Mann–Whitney test. Frequencies were
compared using the Pearson ␹2 test unless the expected coincidental renal insufficiency, and the fraction of pa-
value of any cell was ⬍5, in which case the Fisher’s exact tients who received DDAVP before renal biopsy were
test was used. Potential correlations between variables recorded for the two 5-month intervals.
were evaluated using the Spearman’s ␳ coefficient. All This study was conducted under a protocol approved
statistical tests were performed using SPSS 9.0.1. A prob- by the University of Utah Institutional Review Board.
ability of P ⬍0.05 was considered statistically significant. Interviews were conducted with the written consent of
Use of the BT test during a 5-month period preceding the clinicians.
discontinuation of the test was quantified and summa-
rized by the specialty and ordering physicians. Question- Results
naires for surgical and nonsurgical specialists were con- The algorithm for evaluating the risk of excessive bleed-
structed and acted as the basis for interviews with a ing in patients with a personal or family history of
subset of the physicians who had ordered the BT test bleeding is presented in Fig. 1. Note that, in the absence of
during the 5 months before discontinuation of the BT test a carefully elicited bleeding history, no further work-up
(Table 1). To assess the reliability of the clinicians’ per- was recommended. The number of procedures, and the
ceptions, and to assess the potential impact of a change in clinical services ordering them, in the 5 months before
use of hemostatic agents after discontinuation of the BT discontinuation of the BT test, are summarized in Table 2.
test on bleeding complications, we reviewed the use of the The primary services ordering the BT test were Nephrol-
drug 1-deamino-8-d-arginine vasopressin (DDAVP) dur- ogy, Obstetrics/Gynecology, Hematology (primarily one
ing the 5 months immediately before and after discontin- clinician), Pulmonary (transplant), and Neurosurgery.
uation of the BT test. Administration of DDAVP repre- The predominance of subspecialty services requesting BT
sents the primary intervention taken by clinicians at our tests reflects a relatively conservative use of the BT test.
institution to counteract platelet function defects (e.g., Evaluation of platelet function in patients before kidney
uremia, Von Willebrand’s disease) in patients who are at biopsy (n ⫽ 19), before liver biopsy (n ⫽ 10), or with a
risk and are scheduled to undergo invasive procedures, or history of NSAID ingestion (n ⫽ 5) included ⬎40% of the
who are actively bleeding. The total number of patients indications for a BT test. Before discontinuation of the BT
who received platelet-active doses of DDAVP (⬃0.3 ␮g/kg), test, only one clinician (Neurosurgery) contacted the
as well as the number of DDAVP-treated patients with Laboratory after the notification memo was distributed. A
Clinical Chemistry 47, No. 7, 2001 1207

specifically requested a platelet transfusion to correct an


Table 2. Clinical services at the University of Utah Hospital
acquired platelet function defect in a patient undergoing a
requesting the BT test.
procedure.
Service Number of proceduresa (%)
The rate of postprocedural hemorrhage or hematoma
Nephrology 18 (22.5)
Hematology 10 (12.5)
in patients in the Major Surgery Risk Pool has remained in
OB/Gyn 10 (12.5) statistical control (⬍3␴) in the 5 months since discontin-
Pulmonary 6 (7.5) uation of the BT test (Fig. 2). In fact, the monthly variation
Neurosurgery 5 (6.3) in complication rates has remained within 2␴ of the mean.
Gastroenterology 4 (5) Therefore, there is no evidence that discontinuation of the
Pediatrics 4 (5) BT test has led to an increase in bleeding complications. In
Othersb 17 (21.2) addition, the Laboratory has not been notified of any
Unspecified 6 (7.5) cases of excessive bleeding in surgical patients where
Total 80 discontinuation of the BT test was thought to play a
a
Number of BT tests performed in the 5 months immediately prior to significant role in the clinical outcome.
discontinuation of the test. To assess the possible impact of discontinuation of the
b
Otolaryngology (3), General Surgery (3), Emergency Medicine (3), Urology (2),
General Internal Medicine (2), Orthopedic Surgery (1), Neurology (1), Cardiology
BT test on bleeding complications in a nonsurgical patient
(1), and Family Practice (1). population known to be predisposed to abnormal platelet
function, and who undergo invasive diagnostic proce-
dures, we evaluated the complication rate of kidney
second clinician (Neurosurgery) contacted the Laboratory
biopsy procedures immediately before and after discon-
⬃12 months after discontinuation, asking for a BT test. In
tinuation of the BT test. Demographic variables and
both cases, the concern was related to determining the
potentially significant risk factors were compared for
risk for excessive bleeding in patients taking NSAIDS.
patients undergoing biopsy in the before and after
These were the only inquiries regarding the BT test
5-month intervals. BUN was higher in the patients biop-
fielded by the Laboratory in the 24 months since discon-
tinuation of the test. sied after discontinuation of the BT test, but did not
An evaluation of the ordering frequency of platelet- correlate with the decrease in the postbiopsy hematocrit
aggregation tests revealed no increase during the 5 (rs ⫽ 0.154; P ⫽ 0.224). On the other hand, significantly
months after discontinuation of the BT test compared more renal allografts were biopsied after the BT test was
with either the 5-month period immediately before dis- no longer available (Table 4); and an analysis of the mean
continuation or the same 5-month interval (February decrease in hematocrit for allografts vs native kidneys, for
through June) in 1998 (Table 3). Likewise, there was no all eligible patients (n ⫽ 66), revealed a significantly larger
significant difference in the number of nonirradiated, mean decrease in the hematocrit (P ⫽ 0.008) for allograft
nonleukocyte-reduced platelet units transfused in the 5 kidneys (mean ⫾ SD ⫽ 0.96 ⫾ 2.31; n ⫽ 31) vs native
months before discontinuation of the BT test vs the 5 kidneys (mean ⫾ SD ⫽ 2.68 ⫾ 2.72; n ⫽ 35). This probably
months after, nor for the months of February through accounts for the lower mean decrease in hematocrit
June of 1998 vs 1999 (Table 3). A review of the indications demonstrated by the patients biopsied after discontinua-
for platelet transfusions administered to patients with tion of the BT test, although the difference did not reach
platelet counts in the reference interval over the first 4.5 statistical significance (Table 4). There was no significant
months after discontinuation of the BT test revealed only difference in the incidence of RBC transfusion after biopsy
cardiopulmonary bypass as an indication related to a between the two time intervals (Table 4). Three of the
known, acquired platelet function defect. BT tests had not transfused patients were female, and three had a native
historically been ordered for this group of patients before kidney biopsied. In addition, three of the four patients
discontinuation of the test. In addition, no clinicians have had prebiopsy prothrombin time and/or platelet count

Table 3. Clinician practice behavior before and after discontinuation of the BT test.
BT test available, BT test available, BT test unavailable,
2/98–6/98 9/98–1/99 2/99–6/99 P
Monthly platelet units transfused 44.8 ⫾ 14.8a 42.0 ⫾ 13.9a 41.6 ⫾ 8.6a 0.687b
0.958c
Total platelet-aggregation studies 17 9 9 NTd
Total patients receiving DDAVP NA 24 10 NT
Uremic patients receiving DDAVP NA 22 8 NT
a
Mean ⫾ SD.
b
Student t-test: 2/98 – 6/98 vs 2/99 – 6/99.
c
Student t-test: 9/98 –1/99 vs 2/99 – 6/99.
d
NT, not tested; NA, not assessed.
1208 Lehman et al.: Bleeding Time Test

[General/Trauma, Neurosurgery (2 ), Ear Nose and


Throat], none had changed his or her practice as a result
of discontinuation of the BT test. They reported that they
did not significantly change their preoperative work-ups
(with the exception of elimination of the BT test), post-
poned a surgical procedure, experienced an increase in
bleeding complications, or increased the use of blood
products. However, the concern about preoperative eval-
uation of neurosurgical patients taking NSAIDs or aspirin
was raised again.
The responses from the nonsurgical clinicians were
consistent with those of the surgical faculty. They re-
ported that they had not modified their practices or noted
an increase in bleeding complications, except for one
physician who would consider the use of DDAVP in lung
transplant patients requiring a lung biopsy when the
patient’s BUN was ⬎16.1 mmol/L. This clinician reported
one episode of excessive bleeding associated with a lung
Fig. 2. Rate of postprocedural hemorrhage or hematoma for patients in
biopsy in a transplant patient with uremia. The clinician
the Major Surgery Risk Pool for the 12 months before and 5 months
after discontinuation of the BT test. stated that a preprocedural BT test would normally have
Data are plotted as a “P” control chart with standard upper and lower control been ordered, but would not have affected the timing of
limits of ⫾ 3␴. The months during which the BT test was no longer available are the biopsy.
indicated by an asterisk and by BT Discontinued on the graph. F, observed
monthly rate; ⫺ ⫺ ⫺, standard upper and lower confidence limits; ——, mean A review of the administration of therapeutic (i.e.,
rate. platelet-active) doses of DDAVP to patients before and
after discontinuation of the BT test failed to show an
values that were abnormal. A BT test was not performed increase in the overall use (Table 3), the use in patients
on any of the four patients. with renal disease (Table 3), or the administration imme-
Because clinicians might not have actively reported diately before renal biopsy (Table 4). This is consistent
bleeding complications in patients thought to have had a with the clinicians’ perception of their practices. Admin-
platelet-function disorder, 18 (35%) physicians who had istration of DDAVP represents the primary intervention
ordered a BT test in the 5 months before discontinuation taken by clinicians at our institution to counteract platelet
of the test were interviewed using the questionnaires function defects (e.g., uremia, Von Willebrand’s disease)
presented in Table 1. Of the 4 surgeons interviewed in patients who are at risk for bleeding because of

Table 4. Comparison of renal biopsy patient variables.


Variable BT test available 9/98–1/99 BT test unavailable 2/99–6/99 P
Age, years 38.3 ⫾ 16.8a (n ⫽ 37)b 39.8 ⫾ 19.9a (n ⫽ 44) 0.718c
Sex, % male 56.8 (n ⫽ 37) 63.6 (n ⫽ 44) 0.528d
Creatinine, ␮mol/L 180 (60–1010);e (n ⫽ 35) 180 (60–1370);e (n ⫽ 42) 0.556f
BUN, mmol/L 10.9 (3.2–39.6);e (n ⫽ 34) 14.6 (4.3–50.0);e (n ⫽ 41) 0.025f
Prebiopsy hematocrit 0.361 ⫾ 0.070a (n ⫽ 31) 0.330 ⫾ 0.067a (n ⫽ 36) 0.064c
Prebiopsy hematocrit ⬍0.300, % 25.8 (n ⫽ 31) 33.3 (n ⫽ 36) 0.502d
Coagulopathy, % 27.8 (n ⫽ 36) 24.4 (n ⫽ 41) 0.735d
Thrombocytopenic, % 14.7 (n ⫽ 34) 11.4 (n ⫽ 35) 0.734g
DDAVP,h % 10.8 (n ⫽ 37) 4.5 (n ⫽ 44) 0.404g
Allografts, % 27.5 (n ⫽ 37) 72.5 (n ⫽ 44) 0.001d
⌬ hematocrit 0.023 ⫾ 0.028a (n ⫽ 31) 0.015 ⫾ 0.025a (n ⫽ 35) 0.225c
Transfused, % 5.4 (n ⫽ 37) 4.5 (n ⫽ 44) 1.000g
a
Mean ⫾ SD.
b
All n values in the table represent the total number of patients available for analysis for the time interval.
c
Student t-test.
␹ test.
d 2

e
Median (range).
f
Mann-Whitney test.
g
Fisher’s exact test.
h
DDAVP administered prior to biopsy.
Clinical Chemistry 47, No. 7, 2001 1209

scheduled invasive procedures or who are actively bleed- transfusions did not increase after discontinuation of the
ing. BT test. In addition, an evaluation of the indications for
platelet transfusion in patients with normal counts at the
Discussion time of transfusion failed to identify increased platelet
The role of the BT test in defining the risk of pathologic utilization in patients at risk for acquired platelet dysfunc-
bleeding in “susceptible” populations remains controver- tion. Therefore, we found no evidence of significant
sial. Most literature surveys that have objectively evalu- changes in clinician practice that could have biased our
ated the performance of the BT test have found no clinical assessment of patient outcomes before and after discon-
utility for this test (4 – 6 ). Our study failed to identify a tinuation of the BT test.
clinically significant, negative impact of discontinuing Although our neurosurgeons expressed concerns
availability of the test at our Medical Center. Objective about their ability to identify patients at risk for bleeding
measures of complication rates validated the clinicians’ among those taking NSAIDs, they did not use platelet-
perceptions of unchanged patient outcomes. The rate of aggregation tests as a substitute and did not prescribe
postoperative bleeding in patients undergoing proce- platelet transfusions for patients on NSAIDs. The lack of
dures in the Major Surgery Risk Pool before and after reported bleeding complications in their patients may
discontinuation of the BT test did not change. This sug- suggest that the actual risk attributable to platelet dys-
gests that there was not a dramatic increase in bleeding function is less than that perceived. The degree of risk of
episodes attributable to unidentified platelet dysfunction. bleeding complications in patients undergoing invasive
However, a minor increase cannot be ruled out because procedures who have ingested aspirin or NSAIDs is
ICD-9 codes do not allow stratification of events by root somewhat controversial, even in neurosurgical patients,
cause. Likewise, we were unable to identify an increase in where even a small bleed may be catastrophic (18 –21 ). A
bleeding complications after renal biopsy, whether mea- review of the literature revealed very few case reports of
sured by a decrease in hematocrit or a requirement for presumed NSAID-induced bleeding episodes in patients
RBC transfusions. These findings must be tempered, undergoing neurological procedures, and no true pro-
however, by the potential bias of an increased proportion spective studies could be found (22–25 ). In fact, one
of allograft kidneys in the cohort of patients after discon- author recently concluded that there was insufficient
tinuation of the BT test. It is interesting to note that our evidence of increased risk of bleeding complications in
finding of a smaller decrease in the postprocedural he- patients who received aspirin therapy before central neu-
matocrit in transplant patients is at odds with other ral blockade to recommend a routine preprocedural BT
reports of greater arteriovenous fistula formation (16 ) and test (20 ). In addition, two experimental studies have
a greater decrease in the hematocrit of biopsied transplant demonstrated that the skin template BT is, in fact, not
kidneys (17 ). Transplantation may have been acting as a predictive of visceral BTs in subjects treated with aspirin.
surrogate for an unmeasured variable because renal trans- Treatment of healthy human volunteers with aspirin
plant patients did not differ significantly from nontrans- prolonged the skin BT test, but did not prolong a gastric
plant patients for any other characteristic that was as- mucosal BT test performed during endoscopy (26 ); and
sessed (data not shown). an animal model of neurosurgical bleeding found that
Because clinical outcomes could have been influenced aspirin prolonged the skin BT test, but not a brain BT test
by a change in clinician behavior after discontinuation of induced by a standard incision (27 ).
the BT test, we attempted to assess potentially significant Use of the BT test in clinical medicine relies on the
changes in clinical practices. Interviews with physicians premise that clinically relevant bleeding episodes, during
who had previously ordered the BT test failed to identify or after invasive procedures, can be predicted a priori in
an impact of discontinuation of the test on their clinical susceptible patients, leading to appropriate preventative
practice and/or patient outcomes. None believed he or action. Whereas the BT test may predict a higher bleeding
she had significantly altered preprocedural work-ups or complication rate in populations at risk, it is of limited
periprocedural transfusion practices as a result of discon- assistance in evaluating an individual patient, because of
tinuation of the BT test; and, with one exception, none low sensitivity and specificity. In fact, Lee and Lamila (13 )
could recall a case where he or she felt a BT test might suggest that more harm, in the form of delayed surgery or
have led to an improved outcome. This included 60% of administration of unnecessary or inappropriate blood
the practicing nephrologists, many of whom had fre- products, may be incurred as a result of false-positive BT
quently used the BT test before kidney biopsy. In fact, the tests. The almost uniform lack of clinician concern about
Nephrology Division did not oppose discontinuation of discontinuation of the BT test at our institution suggests
the BT test when they were surveyed before elimination of that the test was not considered to be essential for
the test. Their consensus opinion was that the question- practice, and possibly, unnecessarily obstructive. Many
able utility of the test did not justify the necessary clinicians stated that they had ordered the test because it
maintenance. Consistent with the clinicians’ perceptions was available or because it was how they were trained.
of their practice, utilization of platelet-aggregation tests, The apparent lack of clinically significant adverse
administration of DDAVP, and mean monthly platelet events attributable to discontinuation of the BT test would
1210 Lehman et al.: Bleeding Time Test

suggest the following: (a) in the absence of a personal or coagulation time and report of three cases of hemorrhagic disease
family history of bleeding, excessive bleeding attributable relieved by transfusion. JAMA 1910;55:1185–92.
solely to platelet dysfunction must be relatively uncom- 3. Ivy AC, Nelson D, Bucher G. The standardization of certain factors
in the cutaneous “venostasis” bleeding time technique. J Lab Clin
mon [e.g., in 10 years, Lee and Lamila (13 ) detected only
Med 1941;26:1812–22.
two mild cases of von Willebrand’s disease through the 4. Rodgers RPC, Levin J. A critical reappraisal of the bleeding time.
use of routine preoperative BT tests], and (b) the BT test Semin Thromb Hemost 1990;16:1–20.
does not add significant positive predictive values to 5. Lind SE. The bleeding time does not predict surgical bleeding
routine coagulation parameters and a platelet count, even [Review]. Blood 1991;77:2547–52.
in patients with the potential for undiagnosed, clinically 6. Peterson P, Hayes TE, Arkin CF, Bovill EG, Fairweather RB, Rock
significant platelet dysfunction (e.g., renal failure, liver WA, et al. The preoperative bleeding time test lacks clinical benefit
[Review]. Arch Surg 1998;133:134 –9.
failure). This may be attributable, in part, to relatively
7. Fugh-Berman A. Herb-drug interactions [Review]. Lancet 2000;
recent changes in the clinical management of these pa- 355:134 – 8.
tients. For example, patients suffering from chronic renal 8. Mcdonald R. Bleeding time. Br J Anaesth 1992;69:329.
failure commonly receive erythropoietin therapy, causing 9. Sutor AH. The bleeding time in pediatrics [Review]. Semin Thromb
an increase in their hematocrit, which is thought to Hemost 1998;24:531– 43.
improve primary hemostasis (28 ). Administration of con- 10. Mattix H, Singh AK. Is the bleeding time predictive of bleeding
jugated estrogens, DDAVP, or cryoprecipitate before pro- prior to a percutaneous renal biopsy [Review]? Curr Opin Nephrol
Hypertens 1999;8:715– 8.
cedures performed on uremic patients can correct a pro-
11. Boberg KM, Brosstad F, Egeland T, Egge T, Schrumpf E. Is a
longed BT test, and presumably acquired platelet prolonged bleeding time associated with an increased risk of
dysfunction (29 –32 ), although a cause-and-effect relation- hemorrhage after liver biopsy? [Review]. Thromb Hemost 1999;
ship with decreased hemorrhage has never been estab- 81:378 – 81.
lished. For patients with hepatic failure, wider availability 12. Messmore HL, Godwin J. Medical assessment of bleeding in the
of the transjugular (vs percutaneous) route for hepatic surgical patient [Review]. Med Clin North Am 1994;78:625–34.
biopsies in patients with coagulopathies and/or throm- 13. Lee S, Lamila CM. Reducing the number of routine preoperative
screening bleeding time tests [Letter]. Arch Pathol Lab Med
bocytopenia may have reduced the risk of serious bleed-
1991;115:1088 –9.
ing complications resulting from this procedure (33, 34 ). 14. Rodgers RPC, Levin J. Reducing the number of routine preopera-
Our assessment of the impact of discontinuation of the tive screening bleeding time tests [Letter]. Arch Pathol Lab Med
BT test could have missed infrequent events of bleeding 1991;115:1089.
that might have been avoided by performing the test. In 15. Swift JA. Introduction to modern statistical quality control and
fact, one of the four patients who required RBC transfu- management. Delray Beach, FL: St. Lucie Press, 1995:350pp.
sions after renal biopsy had normal coagulation values, as 16. Stiles KP, Yuan CM, Chung EM, Lyon RD, Lane JD, Abbott KC.
Renal biopsy in high-risk patients with medical diseases of the
well as a normal platelet count. A BT test was not
kidney [Review]. Am J Kidney Dis 2000;36:419 –33.
performed, although it was available at the time. It is 17. Mendelssohn DC, Cole EH. Outcomes of percutaneous kidney
interesting to speculate whether performance of a BT test biopsy, including those of solitary native kidneys. Am J Kidney Dis
would have impacted the clinical outcome. However, 1995;26:580 –5.
because these episodes are rarely, if ever fatal (17, 35–39 ), 18. Belisle S, Hardy JF. Hemorrhage and the use of blood products
and because the clinical effectiveness of the interventions after adult cardiac operations: myths and realities. Ann Thorac
routinely taken to correct an abnormal BT have never Surg 1996;62:1908 –17.
19. Self DD, Bryson GL, Sullivan PJ. Risk factors for post-carotid
been rigorously tested, the cost and significant effort
endarterectomy hematoma formation. Can J Anaesth 1999;46:
required to maintain competency in the face of dwindling 635– 40.
test numbers, and the repercussions of numerous false- 20. Wildsmith JAW, McClure JH. Aspirin, bleeding time and central
positive BT test results, are not clinically justified. neural block [Letter]. Br J Anaesth 1993;70:112.
21. Ferraris VA, Gildengorin V. Predictors of excessive blood use after
In conclusion, our study failed to identify a clinically coronary artery bypass grafting. A multivariate analysis. J Thorac
significant, negative impact of discontinuing availability Cardiovasc Surg 1989;98:492–7.
22. Merriman E, Bell W, Long DM. Surgical postoperative bleeding
of the BT test at a busy, tertiary-care, university medical
associated with aspirin ingestion. Report of two cases. J Neuro-
center serving adult and neonatal patient populations. surg 1979;50:682– 4.
The role for new in vitro methods for assessing platelet 23. Heye, N. Is there a link between acute spinal epidural hematoma
function needs to be well defined, and the tests must be and aspirin? Spine 1995;20:1931–2.
clinically validated before clinical acceptance is attained 24. de Swiet M, Redman CW. Aspirin, extradural anaesthesia and the
(40 ). MRC Collaborative Low-dose Aspirin Study in Pregnancy (CLASP).
Br J Anaesth 1992;69:109 –10.
25. Palmer JD, Sparrow OC, Iannotti F. Postoperative hematoma: a
References 5-year survey and identification of avoidable risk factors. Neuro-
1. Bick RL. Platelet function defects associated with hemorrhage or surgery 1994;35:1061– 4.
thrombosis [Review]. Med Clin North Am 1994;78:577– 607. 26. O’Laughlin JC, Hoftiezer JW, Mahoney JP, Ivey KJ. Does aspirin
2. Duke WW. The relation of blood platelets to hemorrhagic disease. prolong bleeding from gastric biopsies in man? Gastrointest
Description of a method for determining the bleeding time and Endosc 1981;27:1–5.
Clinical Chemistry 47, No. 7, 2001 1211

27. MacDonald JD, Remington BJ, Rodgers GM. The skin bleeding al. Is bleeding time measurement useful for choosing the liver
time test as a predictor of brain bleeding time in a rat model. biopsy route? The results of a pragmatic, prospective multicentric
Thromb Res 1994;76:535– 40. study in 219 patients [Letter]. J Clin Gastroenterol 1999;29:
28. Anand A, Feffer SE. Hematocrit and bleeding time: an update 347–9.
[Review]. South Med J 1994;87:299 –301. 35. Mahal AS, Knauer MC, Gregory PB. Bleeding after liver biopsy.
29. Boyd GL, Diethelm AG, Gelman S, Lagner R, Laskow D, Deierhoi West J Med 1981;134:11– 4.
M, Barber WH. Correcting prolonged bleeding during renal trans- 36. Piccinino F, Sagnelli E, Pasquale G, Giusti G. Complications
plantation with estrogen or plasma. Arch Surg 1996;131:160 –5. following percutaneous liver biopsy. A multicenter retrospective
30. Weigert AL, Schafer AI. Uremic bleeding: pathogenesis and ther- study on 68,276 biopsies. J Hepatol 1986;2:165–73.
apy [Review]. Am J Med Sci 1998;316:94 –104. 37. Little AF, Ferris JV, Dodd GD, Baron RL. Image-guided percutane-
31. Mannuccio PM, Remuzzi G, Pusineri F, Lombardi R, Valsecchi C, ous hepatic biopsy: effect of ascites on the complication rate.
Mecca G, Zimmerman TS. Deamino-8-D-arginine vasopressin Radiology 1996;199:79 – 83.
shortens the bleeding time in uremia. N Engl J Med 1983:308: 38. Benfield MR, Herrin J, Feld L, Rose S, Stablein D, Tejani A. Safety
8 –12. of kidney biopsy in pediatric transplantation: a report of the
32. Janson PA, Jubelirer SJ, Weinstein MJ, Deykin D. Treatment of the Controlled Clinical Trials in Pediatric Transplantation Trial of
bleeding tendency in uremia with cryoprecipitate. N Engl J Med Induction Therapy Study Group. Transplantation 1999;67:544 –7.
1980;303:1318 –22. 39. Hergesell O, Felten H, Andrassy K, Kuhn k, Ritz E. Safety of
33. Sawyer AM, McCormick PA, Tennyson GS, Chin J, Dick R, Scheuer ultrasound-guided percutaneous renal biopsy-retrospective analy-
PJ, et al. A comparison of transjugular and plugged-percutaneous sis of 1090 consecutive cases. Nephrol Dial Transplant 1998;
liver biopsy in patients with impaired coagulation. J Hepatol 13:975–7.
1993;17:81–5. 40. Carr ME Jr. In vitro assessment of platelet function [Review].
34. Bonnard P, Vitte R, Barbare J, Denis J, Stepani P, Di Martino V, et Transfus Med Rev 1997;11:106 –15.

You might also like