Evaluation of Three Modified Ivy Bleeding Time Devices

Hematology
Evaluation of Three Modified Ivy Bleeding
Time Devices
The bleeding time test quantifies the duration of bleeding from a standardized skin wound. The test measures in vivo function of the platelet
capacity to respond to injury, vascular function, and the presence of von
Willebrand's factor. This study compared the range of test results in time,
safety of technique to the technician and patient, patient preference in relation to pain, scarring potential, and cost-effectiveness of three bleeding
time devices used to assess platelet function. The three devices evaluated
were the Simplate by General Diagnostics (Organon-Teknika), Surgicutt by
International Technidyne Corporation, and the Mayo Clinic Automatic Lancet
available through V. Mueller Co.
T
he bleeding time test quantifies
the duration of bleeding from a
standardized skin wound and measures the in vivo platelet and vascular capacity to respond to injury.1
Prolonged bleeding times may occur
in patients with thrombocytopenia,
von Willebrand's disease, Glanzmann's thrombasthenia, BernardSoulier syndrome, platelet storage pool
disease, drug-influenced platelet
problems, mild platelet disorders, and
vascular defects such as Ehlers-Danlos syndrome.2 Duke3 described the
first bleeding time method in 1910.
Since then, two other methods,
namely, the Ivy4 and the template,5
or modifications thereof, have been
described and are in wide use today.
The Duke method involved a small cut
From the Clinical Investigation Facility (Mr McGlasson
and Dr Patterson), the Department of Obstetrics and
Gynecology (Dr Strickland), and the Department of Pathology and Hematology Branch (Dr Hare and Capt
Reilly), Wilford Hall USAF Medical Center, Lackland
AFB, Texas 78236-5300.
The opinions expressed herein are those of the authors and not necess?.-:iy those of the United States
Air Force or the Department of Defense.
being made in the earlobe with a disposable lancet: the normal bleeding
time was one to three minutes. Ivy
increased the sensitivity and standardization of the test by using the
forearm as the site of puncture and
maintaining 40 mm of constant pressure by using a sphygmomanometer.
Two to four punctures were made, and
the average time was determined.
Discrepancies sometimes occurred due
to the uneven cuts from the manual
lancet technique. Other methods using
scalpel blades were described, but
standardization was still difficult.6'7
In 1969, Mieckle,5 using a template
system, attempted to standardize blade
incisions. He used a surgical blade and
a plastic template to provide a guide
through which the blade passed, giving incisions that were purportedly
more consistent in length and depth.
Two incisions were performed and an
average was derived. However, scarring was a problem and the procedure
proved to be very technique dependent, causing a wide variation in normal ranges. Several spring-loaded
devices have since been developed such
as the Simplate, 8 the Mayo Automatic Lancet,9 and the Surgicutt.10 All
of these spring-loaded devices deliver
a standardized incision. The Surgicutt and Simplate yield an incision 5mm long and 1-mm deep. The Mayo
Automatic Lancet is placed at the 5mm setting, giving an incision 5-mm
deep and approximately 2 mm wide,
with a No. 11 Bard-Parker non-ribback blade.11
The following questions related to
the use of these three standardized
devices were addressed in this study:
If only one bleeding time has to be
performed on a patient, is the risk of
scarring acceptable? Which technique
provides the greatest protection to the
technician and the patient? Which
procedure is the most cost-effective?
Which device was preferred by the
patient in relation to pain from the
trauma inflicted by the procedure?
Materials and Methods
Fifty-one normal adult volunteer
subjects were used in this study. The
group included 32 white men, six white
women, eight black men, one Hispanic man, two Hispanic women, and
two Oriental women. Each subject
signed a consent form explaining the
procedure and the risks involved They
answered a questionnaire on their
personal and family history of bleeding that included a checklist for medical disorders and drugs that could
interfere with platelet function.12 14 A
physician reviewed the questionnaire
LABORATORY MEDICINE • VOL 19, NO. 10, OCTOBER 1988 6 4 5
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David L. McGlasson, MS, CLS/NCA; Daniel M. Strickland, MD; Richard J. Hare, MD;
Patricia A. Reilly, MS, MT(ASCP)SH; and Wayne R. Patterson, PhD, MT(ASCP)
Fig 2. Simplate Bleeding Time Device. Incision is made by "guillotine action" of a springloaded blade which them remains exposed from its plastic disposable housing. A shows
nonactivated positions. B, activated position.
with each subject before testing. This
review also included counselling as to
the assessment of pain that was to be
rated for each device by the test subject. Anyone who had a history of abnormal bleeding was excluded. Any
subject taking any medication that
may have affected platelet function
was rescheduled.
Three bleeding t i m e d e t e r m i n a tions were performed on each subject,
one with each of the three devices. The
subject was evaluated on a weekly basis, one technique at a time. A "Latin
Square" design was employed to randomize the order in which the devices
were used to minimize bias. 15 Only one
puncture site was made on the volar
surface of the forearm. This procedure
is in accordance with current literature, suggesting that one incision gives
as much clinical information as multiple incisions, provided the test is
performed properly. 16 The area of the
arm used was the lateral aspect of the
volar surface of the forearm, approximately 5 cm below the antecubital
crease. The area was lightly shaved
of body hair, if necessary, cleansed
with 70% isopropyl alcohol, and a
small horizontal incision was made
with one of the spring-loaded devices.
A stopwatch was started and a filter
paper was used to blot the drop of blood
every 30 sec until the blood no longer
stained the paper. Care was taken not
to actually touch the site of the wound.
In all cases the wounds were "butter-
6 4 6 LABORATORY MEDICINE • VOL. 19, NO. 10, OCTOBER 1988
The S u r g i e u t t devices were supplied by International Technidyne (Fig
1). The Simplates were purchased from
General Diagnostics (Organon-Teknika) (Fig 2). The Mayo Automatic
Lancet was purchased t h r o u g h V.
M u e l l e r C o m p a n y , a d i v i s i o n of
American Hospital Supply Co. (Fig 3).
Data analysis was performed using a
Friedman two-way analysis of variance, followed by a Wilcoxon rank-sum
test for two-sample pair-wise comparisons. 19 Three pair-wise comparisons
were accomplished for each test factor; Bonferroni's adjustment therefore required a P = .016 for statistical
significance at a level of confidence
equivalent to P = .05 for single pairwise comparisons. Simple data descriptions were employed to relate res u l t s of r a n g e , m e a n , s t a n d a r d
deviation, and standard error of mean.
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Fig 1. Surgieutt Bleeding Time Device. Incision is made by action of spring-activated
surgical steel blade. The blade protracts slightly upon activation of device and then retracts
back into the disposable device. (Blade is exposed for demonstration of device only) A shows
nonactivated position. B, activated position.
fly" bandaged for a minimum of 24
hours after the procedure was performed. The senior a u t h o r of t h i s
communication obtained all of t h e
bleeding times in this study, going to
great lengths to ensure that all of the
incisions and wound sites were treated
in a standardized manner. If a bleeding time was beyond pre-established
acceptable normal limits as stated by
the manufacturer, a complete blood
cell (CBC) count with platelet count
was done to ensure the subject was
not thrombocytopenic. 17 None of the
subjects in our study were thrombocytopenic. If any of our subjects had
displayed thrombocytopenia, t h e y
would have been referred to the physician who reviewed the consent form
with the subject. The wounds were
observed by a physician at eight weeks
after testing to evaluate scarring. This
evaluation was performed in a manner similar to a previous system described by Bain 18 in 1983. The degree
of scarring was rated as 0, 1, 2, and
3, with 0 indicating no visible scar; 1,
faint scar (pigmentation); 2, prominent scar; and 3, ugly scar or keloid.
Pain was ranked as 1, 2, and 3, with
a level 1 indicating least painful; 2,
intermediate pain; and 3, most painful. Ties were graded by mean ranking. After the last method was
performed on each subject, the individual was asked to rank the preferred method in relation to the least
painful, intermediate, and most painful procedure in relation to each device.
with the Surgicutt device. This device
was rated second in relation to pat i e n t preference. The Mayo device
produced hematomas in ten of the 51
subjects on whom it was used. This
was most likely due to the deeper incision of 5 mm in relation to the depth
of 1 mm with the other devices. Pat i e n t a s s e s s m e n t of p a i n i n d u c e d
placed it third. Patients commented
that its intimidating size and its noise
during activation were a little disturbing.
Table 1: Range, Mean, and Standard Deviation Comparisons
Device
SD
Mean
Range
Surgicutt
Simplate
Mayo Automatic
Lancet
2 min 0 sec - 9 min 30 sec
2 min 30 sec - 9 min 20 sec
4 min 6 sec
4 min 26 sec
1 min 30 sec - 6 min 40 sec
4 min 6 sec
SEM
1 min 21 sec
1 min 14 sec
1 min 8 sec
11.3 sec
10.4 sec
9.5 sec
Table II: Patient Preference in Relation to Pain*
Device
Surgicutt
Simplate
Mayo Auto Lancet
1, Least Painful
2, Intermediate Pain
3, Most Painful
29
15
15
16
20
10
6
16
26
*1 indicates the number of subjects preferring the device as least painful; 2, number of subjects
picking the device as intermediate in relation to pain; and 3, number of subjects judging the device
as most painful. Surgicutt device was preferred over the Simplate or Mayo Auto Lancet devices
(P = .01). No significant difference was found between the Simplate and the Mayo Auto Lancet.
Table III: Scarring*
Device
Surgicutt
Simplate
Mayo Auto Lancet
0
1
2
3
25
38
46
19
7
5
7
5
0
0
1
0
*0 indicates no visible scar; 1, faint scar (pigmentation); 2, permanent scar; and 3, ugly
scar or keloid. Surgicutt device was associated with more scarring than the Mayo Auto
Lancet (P = .O02). Surgicutt device compared with Simplate device gave no significant
difference. Simplate device was not significantly different from the Mayo Auto Lancet.
Results
The Surgicutt and Simplate devices
produced the widest ranges of bleeding time and the Mayo Automatic
Lancet was narrowest (Table I). The
mean time, the standard deviation,
and the standard error of the mean
were surprisingly similar.
The Surgicutt instrument was preferred by the patients because it caused
less pain more often than the Sim-
plate or Mayo device (P = .01) (Table
II). There was no significant difference in pain between the Simplate and
the Mayo device. The Surgicutt seemed
to give the most uniform incision (investigator observation). Patients noted
t h a t the "click," or activation of the
device, was less "scary" than that of
the other devices. The Simplate incision was not always even and had a
tendency to bleed from the sides of the
wounds rather than being uniform as
Comment
Despite the standardized springloaded incision made by each device,
they were all somewhat technique dependent. Failure to properly place any
of the devices flat on the arm to be
tested or the pressure placed on the
instrument while the incision is made
could affect results of the bleeding
time. Failure to care for the wound
site made by any of the instruments
may drastically elevate the potential
for scarring.
The Surgicutt device appeared to be
the safest for the operator and the patient because the self-contained unit,
when activated, exposed t h e blade
when the incision was made and then
retracted back into the unit. The unit
is disposable and poses no danger to
the technician or other personnel who
may handle it later. The Simplate device left an exposed blade after acti-
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Fig 3. Mayo Automatic Lancet. Incision is made by the action of spring-loaded No. 11
Bard-Parker blade that retracts back into the nondisposable housing device. The blade is
then removed and disposed of. Top device, unhoused blade. Bottom device, housed blade.
The Surgicutt device was associated with more scarring than the Mayo
device (P = .002) (Table III). There
was no significant difference between
the Surgicutt and the Simplate, or the
Simplate compared with the Mayo device. Out of 153 bleeding times obtained, there was only one type 3 scar.
There were 109 bleeding times that
produced no scar, 31 type 1 scars, and
only 12 type two scars.
The cost of these devices at the time
the study was performed are reflected
in Table IV.
Table IV: Cost of Devices Per Unit
Device
Surgicutt
Simplate
Mayo
Automatic
Lancet
Cost
50 units per box—$147.00
(2.94 each)
20 units per pkg—$53.60
(2.68 each)
Single unit cost $175.00
(non-disposable device)
Number 11 Bard-Parker
blades, non rib-back,
150 per box ($.11 each)
LABORATORY MEDICINE • VOL. 19, NO. 10, OCTOBER 1988 6 4 7
Acknowledgments
The voluntary fully informed consent of the subjects
used in this research was obtained as required by
AFR 169-6.
Velma Grantham provided outstanding editorial
support, Majors Frank Wians and Bobby Sawyer
provided assistance in statistics and supplies, and
all of those dedicated health care workers who "volunteered" their arms.
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6 4 8 LABORATORY MEDICINE • VOL. 19, NO. 10, OCTOBER 1988
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vating the device, exposing the
operator and the patient potentially
to further trauma. This device is also
disposable. The Mayo Automatic
Lancet required a manual insertion of
a number 11 Bard Parker blade and
manual adjustment of the blade. It retracts back into the device after the
incision but the operator has to remove the blade manually, exposing the
operator to risk of trauma and contamination. The blades are disposable; the device is not.
The pros and cons of the devices
should be weighed by each laboratory
when choosing a procedure for obtaining bleeding times. Strict standardization of the procedure among trained
technicians seems to be the key to accurate, reproducible, atraumatic results.