Download The Preoperative Bleeding Time Test Lacks Clinical Benefit

ORIGINAL ARTICLE
The Preoperative Bleeding Time Test
Lacks Clinical Benefit
College of American Pathologists’ and American Society
of Clinical Pathologists’ Position Article
Powers Peterson, MD; Timothy E. Hayes, MD, DVM; Charles F. Arkin, MD; Edwin G. Bovill, MD;
Robert B. Fairweather, MD; William A. Rock, Jr, MD; Douglas A. Triplett, MD; John T. Brandt, MD
T
he major conclusions of this position article are as follows: (1) In the absence of a history
of a bleeding disorder, the bleeding time is not a useful predictor of the risk of hemorrhage associated with surgical procedures. (2) A normal bleeding time does not exclude
the possibility of excessive hemorrhage associated with invasive procedures. (3) The bleeding time cannot be used to reliably identify patients who may have recently ingested aspirin or nonsteroidal anti-inflammatory agents or those who have a platelet defect attributable to these drugs. The
best preoperative screen to predict bleeding continues to be a carefully conducted clinical history that
includes family and previous dental, obstetric, surgical, traumatic injury, transfusion, and drug histories. A history suggesting a possible bleeding disorder may require further evaluation; such an evaluation may include performance of the bleeding time test, as well as a determination of the platelet count,
the prothrombin time, and the activated partial thromboplastin time. In the absence of a history of
excessive bleeding, the bleeding time fails as a screening test and is, therefore, not indicated as a routine preoperative test.
Arch Surg. 1998;133:134-139
Historically, the bleeding time test has been
used to evaluate the integrity of primary
hemostasis. The undocumented, but widespread, assumption is that the bleeding
time correlates better with a hemorrhagic tendency in disorders of platelet
function than any other in vitro test. As a
consequence, the bleeding time is often determined prior to invasive procedures in
an attempt to predict the risk of hemorrhagic complications. Recently, the indications for the clinical use of the bleeding time have come under closer scrutiny,
resulting in an increase in the controversy regarding the appropriate use of the
bleeding time test.1-4 Some of the underlying issues in this controversy include a
desire to have a test that accurately predicts the risk of procedure-associated hemorrhage, fear of litigation in the event of a
major hemorrhage, lack of understanding of the limitations of the bleeding time
test, efforts to control rising health care
costs, and increasingly limited laboratory resources. The goal of this position
The affiliations of the authors appear in the acknowledgment section at the end of
this article.
article is to generate a consensus that a routine preoperative bleeding time test is not
warranted in the patient who does not have
a history of a bleeding disorder.
BACKGROUND INFORMATION
The bleeding time is an indicator of in vivo
primary hemostasis.5 It is prolonged in patients with quantitative or qualitative platelet disorders or both and in patients with
abnormalities of vascular wall integrity.
The bleeding time test assesses the formation of a platelet plug in a skin wound and
reflects complex pathophysiological
mechanisms that are not completely understood. In general, the bleeding time test
is performed by making a small incision
in the skin and then determining how long
it takes for blood flow to cease.
Historically, the bleeding time test has
been plagued with problems of reproducibility. Numerous modifications have resulted in a more standardized format and
instrumentation for performing the test.
More than 50 years ago, Ivy et al6 advocated incising the lateral aspect of the volar surface of the forearm and using a
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sphygmomanometer to elevate capillary pressure and
maintain a constant capillary tone, thereby controlling
a major variable—collapse of the vessel wall. Almost 25
years ago, Mielke et al7 introduced the template technique to address standardization of the length and the
depth of the incision. More recently, disposable devices
based on the approach by Mielke et al have been introduced.8,9 Recent work suggests that these modifications to the Ivy technique have not notably improved
the reproducibility, sensitivity, or specificity of this
procedure.10,11 Despite these attempts to standardize
technique, the bleeding time test continues to be
affected by numerous technical variables and clinical
conditions (Table).1,5,12-45
There is a relationship between the platelet count
and the bleeding time that was shown in the classic study
of Harker and Slichter.20 Their study of clinically stable,
nonmedicated subjects with pure platelet production defects showed that the bleeding time is normal when the
platelet count is greater than 1003109/L. However, the
results of their study cannot be generalized because the
patient population they examined is not representative
of the patients for whom the bleeding time might be used
to make clinical decisions.1 There are clinical conditions, such as systemic lupus erythematosus and uremia, for which the bleeding time may be prolonged with
mild thrombocytopenia and for which bleeding problems are more likely a reflection of dysfunctional platelets rather than mild thrombocytopenia. Furthermore,
there are conditions, such as idiopathic thrombocytopenic purpura, for which the bleeding time may be shorter
than would be expected based on the platelet count. Because the correlation between the bleeding time and the
platelet count may vary markedly, the bleeding time
should not be used as an estimate of the platelet count.
STUDIES CONCERNING THE PREOPERATIVE
USE OF THE BLEEDING TIME TEST
One to 2 million bleeding time procedures are performed each year in the United States, making it one of
the most widely used tests of hemostasis.4,46 Most of these
bleeding time tests are probably performed in anticipation of surgery or other invasive procedures.47 The bleeding time test was introduced in an era when clinical tests
were not scrutinized for their predictive value, quickly
became established as a “routine” test, and has been promoted as an aid to diagnosis, prognosis, and the monitoring of therapy.1,2 It was assumed to be an effective
screening test for congenital disorders of platelet function and a predictor of the risk of bleeding. Despite its
widespread clinical use, the bleeding time test is not a
good preoperative screening tool for the general population.1,2,47,48
Preoperative Evaluation of Risk of Bleeding
Excessive perioperative bleeding secondary to a preexisting hemorrhagic disorder in a patient with no history
of excessive bleeding is a rare event.1,2,46-48 When a test
is used to screen a low-risk population for an uncommon event, a positive result is often a false positive. In
Factors Affecting the Bleeding Time Test
Technical variables*
Previous test within 4 h
Cold applied to adjacent skin
Vigorous exercise
Variations in cuff pressure
Excessive wiping of the incision
Excessive anxiety
Direction of the incision
Age and sex
Drugs and medication†
Aspirin
Nonsteroidal anti-inflammatory agents
Antibiotics
b-Blockers
Calcium channel blockers
Alcohol ingestion
Clinical conditions
Congenital‡
von Willebrand disease
Glanzmann thrombasthenia
Bernard-Soulier syndrome
Hermansky-Pudlak syndrome
Platelet-release disorders
Other§
Uremia
Liver disorders
Chronic myeloproliferative disorders
Myocardial infarct
Atherosclerotic cardiovascular disease
Diabetes mellitus
Hematocrit
Paraproteinemias
*From references 5 and 12 through 18.
†From references 23 through 26, 29 through 36, 38 through 40, and 62.
‡From Rao.19
§From references 18, 22 through 28, and 41 through 45.
other words, the predictive value of a positive test in such
a situation is poor. Barber et al47 reviewed 1941 consecutive template bleeding times, approximately 95% of which
were used for a preoperative screen. Only 110 (6%) of
the patients were found to have an abnormal bleeding
time. Eighty-three (75%) of these patients could have been
predicted to have an abnormal bleeding time from an adequate clinical history. No obvious cause for the prolonged bleeding time could be found in the other 27 patients. Seventeen of these 27 patients later underwent a
second bleeding time test; of these tests, the results for
12 were normal, suggesting that most of these long bleeding times were false positives due to technical artifact.
There are insufficient data to accurately calculate the
sensitivity, specificity, or predictive value of the bleeding time regarding perioperative or postoperative hemorrhage.1,2 Rodgers and Levin1 were able to identify only
2 published studies with sufficient data to prepare receiver operating characteristic curves. The receiver operating characteristic curves from these studies indicated that the bleeding time behaved like a noninformative
test in predicting the risk of bleeding.
Recent reviews have highlighted the inability of the
bleeding time to predict excessive surgical bleeding.1,2,4
Multiple studies have found no relationship between the
preoperative bleeding time and the amount of blood loss
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associated with cardiopulmonary surgery.29,49-54 In one
double-blind study, the hemostatic integrity of 101 consecutive patients was evaluated preoperatively by 2 hematologists.55 They stratified the patients into 3 groups
according to the anticipated risk of bleeding; 7 of 8 highrisk patients were classified as such based on a prolonged bleeding time. Only 2 of the 17 patients who experienced excessive bleeding were prospectively classified
as high risk. Two patients died as a result of excessive
intraoperative hemorrhage; neither had been classified
as high risk. Ferraris and Swanson 56 prospectively
evaluated the conditions of 129 patients requiring
urgent, unplanned, general surgical procedures. Eight
of these patients had a prolonged bleeding time preoperatively; none of these 8 patients had excessive bleeding. Handler et al57 observed 38 patients with postoperative bleeding in a series of 1445 patients undergoing
tonsillectomy; there was no difference in the mean
bleeding time between patients with (5.46-minutes)
and without (5.34-minutes) postoperative bleeding. In
a subsequent study, they identified 3 of 1603 patients
with a long bleeding time prior to tonsillectomy. The
results of a subsequent bleeding time test were abnormal in only one of these patients; this patient had von
Willebrand disease and also had a prolonged activated
partial thromboplastin time.30
There is little information regarding the efficacy of
the bleeding time test in predicting hemorrhagic risk associated with specialized surgery or other invasive procedures. In a prospective study of 139 patients undergoing cataract extraction, hyphema developed in 3 (19%)
of 16 patients with a prolonged bleeding time compared
with 10 (9.5%) of 105 patients with a normal preoperative bleeding time. 58 Although these data suggest a
trend towards an increased risk of hyphema with a long
bleeding time, the difference was not statistically significant. Furthermore, the relationship between aspirin
ingestion and prolongation of the bleeding time was not
addressed. Amrein et al59 addressed the effect of perioperative administration of aspirin on bleeding in patients
undergoing hip surgery. While there was a slight
increase in blood loss associated with the administration of aspirin, there was no association between the
preoperative bleeding time and surgical blood loss.
Hematoma formation is a rare, but feared, complication of epidural and spinal anesthesia.60-64 The potential association between the common use of nonsteroidal anti-inflammatory drugs, abnormalities of platelet
function, and hematoma formation have led some to recommend that a bleeding time test be performed before
epidural anesthesia and that a bleeding time in excess of
10 minutes is a relative contraindication for epidural anesthesia.64 There are inadequate data to support this conclusion.58 Horlocker et al65 found that 39% of the patients undergoing spinal or epidural anesthesia were
exposed to antiplatelet medications in the preoperative
period. Neurologic complications in association with the
procedure did not develop in any of these patients. Odom
and Sih66 reported their experience with 1000 cases of
epidural anesthesia given to patients receiving oral anticoagulants. They observed no complications that could
be related to bleeding or hematoma formation in the ex-
tradural space. There are anecdotal cases of spinal subdural bleeding in association with the use of antiplatelet
medications; however, the preoperative bleeding time has
not been uniformly prolonged in these cases. 31,32 Finally, as discussed in the section on “Evaluation of Risk
of Bleeding in Patients Taking Aspirin or Nonsteroidal
Anti-inflammatory Drugs,” the bleeding time is not a sensitive test when used to detect the preoperative use of aspirin. Thus, even if there is a slight association between
the preoperative use of aspirin and hematoma formation following epidural or spinal anesthesia, the bleeding time is not an adequate test to identify patients who
have taken aspirin.
Evaluation of Risk of Bleeding in Patients Taking
Aspirin or Nonsteroidal Anti-inflammatory Drugs
The bleeding time is also often misused to identify patients who may have recently ingested a drug, usually aspirin, known to interfere with platelet function. A history of aspirin ingestion has been associated with increased
blood loss in some clinical settings, including open heart
surgery, hip surgery, delivery of a neonate, and gastrointestinal bleeding.33-36 The clinical desire to identify such
patients is easy to understand. However, there are 2 basic problems with using the bleeding time for this purpose: (1) the bleeding time is not effective in identifying
such patients and (2) the correlation between bleeding
and prolongation of the bleeding time is poor in such
patients.
The ingestion of 650 mg of aspirin by volunteers
resulted in a method-dependent mild increase in the
bleeding time compared with the individual’s baseline
bleeding time.7,26 However, in most of the individuals
studied, the bleeding time remained within the normal
range. In a study of patients receiving long-term aspirin
therapy, the mean (±SD) bleeding time in patients receiving 300 mg of aspirin a day was 217± 69 seconds;
in patients receiving 1200 mg of aspirin a day, it was
240± 60 seconds; and in patients receiving placebo, it was
217± 63 seconds.37 In a case-control study, Bashein et al33
found that the preoperative bleeding time (±SD) in patients taking aspirin within 7 days of open heart surgery
was 5.5± 2.2 minutes compared with 4.9± 1.1 minutes
in those not taking aspirin during this period. Although
the difference in mean bleeding time was significant, there
was too much overlap between the 2 groups to make the
bleeding time a clinically useful procedure. In a study of
patients requiring unexpected surgery, Ferraris and
Swanson56 found that the bleeding time was prolonged
in only 8 of 22 patients with a history of recent aspirin
ingestion, documented by suppression of thromboxane
B2 levels. These studies indicate that the bleeding time
cannot be used to reliably identify patients who have recently received aspirin.
Although a history of aspirin ingestion has been associated with bleeding in patients with some conditions, there is little evidence that increased blood loss in
such patients can be predicted by the bleeding time. In
their evaluation of the effect of aspirin ingestion on bleeding associated with hip surgery, Amrein et al59 found no
correlation between increased bleeding and a bleeding
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time of greater than 10 minutes or an aspirin-induced
prolongation of 4 minutes over baseline. As noted previously, Ferraris and Swanson56 found no relationship between surgical bleeding and either preoperative bleeding time or history of aspirin ingestion in their study of
patients requiring urgent surgical procedures. The relationship between a history of aspirin ingestion, preoperative bleeding time, and perioperative blood loss has
also been examined in patients undergoing cardiopulmonary bypass surgery.33,37,39 These studies have shown
that there is an association between a history of aspirin
ingestion and blood loss but that there is no relationship between the preoperative bleeding time and blood
loss. Finally, O’Laughlin et al40 found that while the skin
bleeding time was prolonged after aspirin ingestion, the
gastric bleeding time following a gastric biopsy was normal, suggesting that a long skin bleeding time may not
accurately predict the response to vascular injury at other
sites.
Therefore, the most effective method of identifying
patients who may be at risk because of aspirin ingestion
is the clinical history. The critical period for exposure
to aspirin seems to be approximately 3 days prior to an
invasive procedure. A recent study67 documented that
platelet function, as measured by thromboxane A2 production and aggregation studies, returned to normal 4
days after the cessation of aspirin therapy. Another study68
showed that aspirin-induced prolongation of the bleeding time lasts no longer than 48 hours. The prolonged
bleeding time in patients taking aspirin may be shortened after the administration of desmopressin acetate;
however, there is no evidence that this translates into decreased perioperative blood loss.41
Evaluation of Risk of Bleeding
in Patients With Uremia
Uremia is a complex metabolic disorder that has deleterious effects on hemostasis. The hemostatic defect associated with uremia is complex and multifactorial and has
not yet been fully delineated.69 In recent years, it has become evident that a low hematocrit is associated with a
prolonged bleeding time in patients with uremia and that
correction of the hematocrit by transfusion or use of recombinant erythropoietin is associated with normalization of the bleeding time in most patients.70-72 Uncontrolled studies have suggested that the normalization of
the bleeding time with increasing hematocrit is associated with a decreased incidence of bleeding.71-74 This effect seems to be due to improved interaction between circulating platelets and the vessel wall, as well as alteration
of a plasma defect associated with uremia.75
The bleeding time has also been used to assess other
forms of intervention in patients with uremia. Several studies have shown that the bleeding time decreases following the intravenous or subcutaneous administration of
desmopressin acetate within 4 to 6 hours.76 The bleeding time has also been used to monitor the response to
cryoprecipitate or conjugated estrogens.42,77,78 In all these
reports, there is anecdotal evidence that correction of the
bleeding time was associated with decreased clinical bleeding. Indeed, it has been suggested that the bleeding time
may be the best indicator of bleeding risk in patients with
uremia.43 Other studies evaluating the relationship between bleeding of widely varying severity and prolongation of the bleeding time have failed to establish the use
of the bleeding time for the prediction of clinically
severe bleeding in advance of its occurrence.44,45,79,80 In
particular, the study by Eknoyan et al44 showed that a
decline in prothrombin consumption was more predictive of bleeding than any other parameter studied,
including the bleeding time. Although some studies
have shown a reasonable correlation between the bleeding time and “clinical” bleeding (as distinguished from
“surgical” bleeding) in patients with uremia, no controlled study has shown that patients with prolonged
bleeding times have more clinically significant complications than those with normal bleeding times.1,2,22,43
Thus, the bleeding time may be useful for monitoring
the response to therapy in patients with uremia. However, there is little direct evidence indicating that the
bleeding time can be used to predict the risk of bleeding
in these patients, particularly in a patient undergoing an
invasive procedure.
CONCLUSIONS
In addressing the issues of concern regarding this laboratory test, we conclude the following:
1. In the absence of a clinical history of a bleeding
disorder, the bleeding time is not a useful predictor of
the risk of hemorrhage associated with surgical procedures.
2. A normal bleeding time does not exclude the possibility of excessive hemorrhage associated with invasive procedures.
3. The bleeding time cannot be used to reliably identify patients who may have recently ingested aspirin or
nonsteroidal anti-inflammatory agents, or who have a
platelet defect attributable to these drugs.
The best preoperative screen to predict bleeding continues to be a carefully conducted clinical history, which
includes family and previous dental, obstetric, surgical,
traumatic injury, transfusion, and drug histories. A patient with a history suggesting a possible bleeding disorder may require further examination. In the absence
of a history of excessive bleeding, the bleeding time fails
as a screening test and is, therefore, not indicated as a
routine preoperative test.
This study was supported by the College of American Pathologists, Northfield, Ill, and by the American Society of
Clinical Pathologists, Chicago, Ill.
From the Departments of Pathology, Cornell University Medical College, New York, NY (Dr Peterson); Maine
Medical Center, Portland (Dr Hayes); University of Vermont College of Medicine, Burlington (Dr Bovill); Dartmouth-Hitchcock Medical Center, Lebanon, NH (Dr Fairweather); University of Mississippi Medical Center, Jackson
(Dr Rock); Ball Memorial Hospital, Muncie, Ind
(Dr Triplett); and Ohio State University College of Medicine, Columbus (Dr Brandt); and the Department of Laboratory Medicine, Boston University Medical Center,
Boston, Mass (Dr Arkin). Dr Peterson is now with the De-
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partment of Pathology and Laboratory Medicine, Medical
College of Pennsylvania and Hahnemann University School
of Medicine, Allegheny University of the Health Sciences,
Philadelphia.
Reprints: College of American Pathologists, 325
Waukegan Rd, Northfield, IL 60093-2750.
29.
30.
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IN OTHER AMA JOURNALS
JAMA
Electronic Communication With Patients: Evaluation of Distance Medicine Technology
E. Andrew Balas, MD, PhD; Farah Jaffrey, MSc; Gilad J. Kuperman, MD, PhD; Suzanne Austin Boren, MHA;
Gordon D. Brown, PhD; Francesco Pinciroli, LEE; Joyce A. Mitchell, PhD
Objective.— To evaluate controlled evidence on the efficacy of distance medicine technologies in clinical practice and health
care outcome.
Data Sources.—Systematic electronic database and manual searches (1966-1996) were conducted to identify clinical trial
reports on distance medicine applications.
Study Selection.—Three eligibility criteria were applied: prospective, contemporaneously controlled clinical trial with random assignment of the intervention; electronic distance technology application in the intervention group and no similar
intervention in the control group; and measurement of the intervention effect on process or outcome of care.
Data Extraction.—Data were abstracted by independent reviewers using a standardized abstraction form and the quality of
methodology was scored. Distance technology applications were described in 6 categories: computerized communication,
telephone follow-up and counseling, telephone reminders, interactive telephone systems, after-hours telephone access, and
telephone screening.
Data Synthesis.—Of 80 eligible clinical trials, 61 (76%) analyzed provider-initiated communication with patients and 50
(63%) reported positive outcome, improved performance, or significant benefits, including studies of computerized communication (7 of 7), telephone follow-up and counseling (20 of 37), telephone reminders (14 of 23), interactive telephone
systems (5 of 6), telephone access (3 of 4), and telephone screening (1 of 3). Significantly improved outcomes were demonstrated in studies of preventive care, management of osteoarthritis, cardiac rehabilitation, and diabetes care.
Conclusions.—Distance medicine technology enables greater continuity of care by improving access and supporting the
coordination of activities by a clinician. The benefits of distance technologies in facilitating communication between clinicians and patients indicate that application of telemedicine should not be limited to physician-to-physician communication.
JAMA. 1997;278:152-159
Reprints: E. Andrew Balas, MD, PhD, School of Medicine, University of Missouri–Columbia, 324 Clark Hall, Columbia, MO 65211
(e-mail: [email protected]).
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