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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
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
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
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Clinical Chemistry 47, No. 7, 2001 1211
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