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3364
DE CATERINA ET AL
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3365
corporeal circulation. Multiple regression analysis was also performed to assess the possible independent effect of bleeding time
parameters and parameters related to the length of operation on one
side and estimates of surgical bleeding on the other. Comparison
of the bleeding time curves before and after drug interventions was
performed by the Kolgomorov-Smirnov statistiscs. The level of significance was set at P < .05.
RESULTS
0,5 1 1 . 5 2 2.5 3 3 . 5 4 4 . 5 5 5 . 5 6 6 , 5 7 7.5
TIME,min
BLEEDING TIME
PEAK BLEEDING
RATE
TIMETOPEAKBLEEDING
TIME,
min
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3366
DE CATERINA ET AL
y =
112.92
R"2
44.595X
D
0.441
= 0.66
R
El
n = 6 9
10
12
BT (min)
y = 3.0692
R"2 = 0.249
5.1627X
loo]
R = 0.50
.1 2 ; . t i
y = 0.54772
10
BT (min)
6.635Oe-2x
R"2
= 0.063
R
DISCUSSION
0.25
!
2
I
4
#
6
12 8
,
10
Bleeding
Time
(min)
BT (min)
Fig 2. Simple linearregressionanalysis
between the bleeding
time (BT; independent variable, x, on the abscissas) and related parameters (dependent variables, y, on the ordinates)derived from the
analysis ofthe bleedingtime curve: total bleeding (A), peakbleeding
rate (B), and time to peak bleeding (C). The equations from linear
regression analysisand the relative coefficients ofcorrelation ( R I are
shown. Rvalues are significant forthe first two correlations, but not
for the third one.
Before ASA
Mean
SD
% CV70
After ASA
Mean
21.5
SD
% CV
P (before v after)
Before NTG
Mean
SD
% CV
After NTG
34.7
Mean
SD
% CV
P (before v after)
Total
Bleeding
(rng)
Peak
Bleeding
Rate
(mgI30 S)
Time to
Peak
Bleeding
(min)
6.2
1.9
31
20.3
14.2
4.5
1.9
42
1.2
0.3
25
9.5
2.2
23
1.05
45.0
48
6.1
2.2
36
<.05
<.05
1.2
0.4
33
NS
7.4
1.o
14
23.9
11.4
48
4.5
1.9
42
1.2
0.4
33
8.6
1.3
15
1.05
13.0
31
5.5
2.5
45
NS
1.9
0.6
32
NS
1.05
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3367
6
1
5m
pre-ASA
post-ASA
t-
+I
n = 10
md,
E
10
12
TIME (min)
TT
IY
T
hT
pre-NTG
post-NTG
INTRA-OBSERVER VARIABILITY
n = 10
70
n
U)
h
0
+I
z
10
12
TIME (min)
5I
6ol T
50
Fig 3. Modifications of the bleeding time curves after the intrave- >
0
nous administration of aspirin
(500 mg, A) or the sublingual administration of nitroglycerin (B). Values at each time point represent the
mean ? SEM of determinations in 10 different subject for each drug
studied. The curves before and aftereach pharmacological interventions differ more ( P < .01 at Kolgomorov-Smirnov statistics) than
the bleeding time( P< .05 at Students t-test for paired data). Note
the clear increase in the size of the curves after each pharmacologic
intervention(increase in total bleeding), with anincrease in the
bleeding time and the
peak bleedingrate, but n o t in t h e t i m e peak.
to
BT
TOTAL
PEAK
BLEEDING
RATE
TIME
TO PEAK
BLEEDING
INTER-OBSERVER
VARIABILITY
n
1910 by Duke.19 Subsequentimportant modifications attempted at standardizing the procedure were introduced by
Ivy et aI2and Mielke et a1.I4The test is currently performed
by means of disposabledevices producing an incision of
relatively consistent depth and lengthand measuringthe time
intercurring from the incision to the arrest of the hemorrhage
afterperiodicblotting
of thewound. Practicallyunquestioned as to its clinical usefulness until the mid-l980s, despite the lack of appropriately controlled studies addressing
the issue of its predictive ability with regard
to the risk of
actual bleeding, the validity of the bleeding time as an
useful
clinical test has been seriously questioned by a number of
inve~tigator?~and, particularly, by the accurate and complete reanalysis of the literature up to 1986 by Rodgers and
L e ~ i nUnder
. ~ discussion is not so much the value of the test
as an epidemiologic or pharmacologic tool to explore primary hemostasis, but rather its practical usefulness
in predicting bleeding episodes inpatients with a previously nega-
U)
+I
5a
8
>
40
30
20
0
10
A
Y
B T PEAK TOTAL
BLEEDING
BLEEDING
RATE
TIME
TO PEAK
BLEEDING
From www.bloodjournal.org by guest on October 26, 2016. For personal use only.
3368
DE CATERINAET
Bleeding time
Bleeding time
Bleeding time
Bleeding time
Bleeding time
Linear Regression
Equation
y = 729.33
Total
Total
Total
Total
Total
y =
bleeding
bleeding
bleeding
bleeding
bleeding
Total bleeding
Peak bleeding
Peak bleeding
Peak bleeding
Peak bleeding
Peak bleeding
Peak bleeding
+ 32.60~
y = 41.87 - 0.46~
Coefficient of
Correlation
(R)
.l4
.00
y = 38.36 + 0.24~
.05
y = 46.89 - 0.67~
.l7
.03
y = 2.23 - 0.03~
.03
y = 3.01 - 0.14~
+ 3.83~
+ 0.06~
856.21
y = 40.37
y = 37.12 + 0.18~
y =
y =
2.39 - 0.01~
39.64 + 0.02~
.l 1
.oo
.27
.09
.00
y = 2.14 - 0.01~
.l4
y = 808.45 + 24.54~
y = 3.69 + 0.12~
.l4
.07
.27
y = 36.46 + 0.98~
y = 2.31 - 3.74~
AL
bleeding are both continuous variables. We tested the hypothesis that the hemostatic competence of a patient is related to the results of the bleeding time test.
We first determined the relationship among the various
parameters derived from the bleeding time procedure. The
significant correlation found between bleeding time on one
side and total bleeding and peak bleeding rate on the other
allows us to reach the conclusion that the bleeding time is
indeed a measure of the total amount of blood loss from the
standardized cutaneous incision. However, the relatively low
correlation coefficients between the bleeding time and some
of the alternative parameters derived from the analysis of the
bleeding time curve (see Fig 2) also suggested the exitence of
bleeding determinants during the test procedure not assessed
by the bleeding time. Therefore, determination of parameters
of actual bleeding during the bleeding time procedure might
offer better correlates with blood losses at surgery. Pharmacologic interventions increasing the bleeding time (aspirin
and nitroglycerin in our case) also increase the total amount
.05
y = 39.13 + 0.19~
.03
y = 2.14 - 0.04~
.08
BP23
y = 3.5393
0.16057X
R"2 = 0.005
R=0.07
El
B
D
B
--
B
Q
'B
--.
10
bleeding time ( m i d
BP23
2000
y = 546.86
1000
B
0 Qm
El
O !
2
10
bleeding time ( m i d
Fig 5. Linear regression analysis
of the bleedingtime (BT; x, on the
abscissas)and indices of postoperativebleeding, y, on the ordinates
(chest tube drainage in [AI and transfusion units in [B]) in bypass
surgery patients homogeneous by operation complex'm (three or
more bypasses [BPI applied; operation time, 2.3 to 4.5 hours; time
of extracorporeal circulation, 65 to 135 minutes). Both correlation
coefficients ( R I are nonsignificant. Transfusionunits equal the number of units of whole blood plus the number of units of plasma.
From www.bloodjournal.org by guest on October 26, 2016. For personal use only.
3369
From www.bloodjournal.org by guest on October 26, 2016. For personal use only.
DE CATERINA ET AL
3370
29. Babson S, Babson A: Development and evaluation of a disposable device for performing simultaneous duplicate bleeding time
determinations. Am J Clin Pathol 70:406, 1978
30. Beaumont J-L, Willie A, Lentgre J: Influence de Iacide acetilsalicylique sur Ihbmostase. Bull Mem Soc Med Hop Paris 7 I : 1077.
1955
3 I . Goldman S, Copeland J , Moritz M, Henderson W, Zadina K,
Ovitt T, Doherty J, Read R, Chesler E, Sako Y, Lancaster L, Emery
R, Sharma G, Josa M, Pacold I, Montoye A, Parich D, Sethi G, Holt
J , Kirklin J, Shabetai R, Moores W, Aldridge J, Masud Z, DeMots
H, Floten S, Haakerson C, Harker L: Improvement in early saphenous vein graft patency after coronary artery bypass surgery with
antiplatelet therapy: Results of a Veterans Administration Cooperative Study. Circulation 77: 1324, 1988
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