Transcript Improved coagulation after cardiopulmonary bypass using

Improved Coagulation After Cardiopulmonary Bypass
®
Using the Hemobag
Scott R. Beckmann, B.S.,C.C.P. Thomas Winkler, M.D., William Shely, M.D., Salem Hospital, Salem, OR, 97301 USA
Introduction
Preserving blood components
There are increasing international stresses within healthcare
regarding the allogeneic blood supply, its use and associated
costs and morbidity (1). The concern is arguably one of greatest
in the cardiac surgery arena today (2).
Improved blood administration practices have been encouraged
by multiple professional societies whose members provide
cardiac surgical care. (3-4).
The Hemobag® Blood Salvage Device is a reservoir system that
allows the patient’s own whole blood to be salvaged, quickly
hemoconcentrated and safely infused. It efficiently uses the
same convenient reservoir bag while insuring CPB circuit
integrity for reinstituting bypass safely and securely, if
necessary.
®
Hemobag
Group
Patient Plt Pkg RBC FFP Cryo ANH HB Vol
0
0
0
450
0
730
0
2
2
3
3
0
360
0
1215
8
3
0
2
0
0
500
0
750
2
4
3
6
8
10
400
0
2500
27
5
10
0
2
0
450
0
750
12
6
0
0
0
0
0
0
900
0
7
2
0
2
0
350
0
750
4
8
0
2
0
0
400
0
720
2
9
0
0
0
0
400
0
700
0
10
0
0
2
0
480
0
720
2
1
0
0
0
0
900
1000
225
0
2
0
0
0
0
600
900
0
0
3
0
0
0
0
800
900
450
0
4
2
0
4
2
400
800
225
8
5
0
0
0
0
350
600
225
0
6
0
0
0
0
0
800
450
0
QUICK VOLUME LINE
7
0
0
0
0
800
1000
225
0
FOR ANESTHESIA OR TO
8
0
0
0
0
400
2150
0
0
9
0
0
0
0
350
550
225
0
10
0
0
0
0
480
1250
450
0
Hemobag®
Patients
Figure 1
THE FIELD (if necessary)
Note: The number of platelet packs (Plt Pkg), units of red blood cells (RBC), fresh frozen plasma
(FFP) and cryoprecipitate (Cryo) transfused in the first hours after protamine infusion. ANH is acute
normovolemic hemodilution and ATS is autotransfusion washed RBCs. Donor exposures (Dnr Exp)
are the total number of allogeneic donor exposures observed.
Table 2
Method
The decision to transfuse allogeneic blood bank products was
made by the same physicians using the same transfusion
criteria for both groups of patients during the time periods in
this study.
Process indicators and central hospital laboratory results were
statistically compared by independent group t-test or ANOVA
between the NHB and HB patients before and after the first
hours immediately after protamine administration and the
reinfusion of ATS, ANH and HB blood. Specific factor
comparisons were made employing Bonferroni adjustments.
The alpha level was set at 0.05 or 0.10 depending on the
factors. Statistical analysis was performed using SPSS
software (SPSS 14.0, Chicago, IL).
** References available on
handout copy of poster.
Dnr Exp
0
There are vast differences in transfusion practices between
cardiac surgical facilities throughout the world (5). As well, there
are numerous blood conservation maneuvers that are employed
during cardiac surgery that have not been widely adopted as
standard of care (6-8).
A prospective, evenly matched two-cohort case series design
was constructed. Hematocrit, platelet count, fibrinogen
concentration ([Fib]), PT, PTT and INR values were compared
in 10 Hemobag® (HB) and 10 non-HB (NHB) adult cardiac
surgical patients at two times after CPB: 1) post acute
normovolemic hemodilution (ANH) infusion and protamine
administration, and 2) after admission to the ICU approximately
one hour after CPB and HB infusion.
An ANH volume (about 4 cc/kg) was withdrawn from each
patient after heparinization, sequestered and returned
immediately after protamine administration in both the HB and
non-HB patients. Cell processing (Cell Saver® 5; Haemonetics
Corporation, Braintree MA) was also employed in both groups
of patients to conserve blood. Immediately post-bypass, the
residual CPB circuit blood was processed by the Cell Saver® 5
in the NHB patients and the Hemobag® technique was utilized
in the HB patients (Figure 1). Residual heparin in the HB
contents was neutralized with an additional 50mg of protamine
sulfate after infusion.
ATS
1
NonHemobag®
Patients
Table 1
Patient data from an underutilized ultrafiltration technique (the
Hemobag®) to process residual extracorporeal circuit blood is
presented as an example of a means to reduce allogeneic blood
related risks and costs (9).
This technology allows for the infusion of shed / residual blood
without creating disturbances in hemodynamic or biochemical
parameters, and avoidance of clinical complications or any
increase in morbity (9-10, 16-17). Further studies indicate that
in over 50% of patients, FFP transfusion does not reliably
reduce the PT or INR and exposes patients to unnecessary risk
(18-19).
and allogeneic blood use
Results
Table 1 lists the patient-by-patient allogeneic, ANH, ATS and
Hemobag® volumes used in the few hours immediately postprotamine sulfate infusion. Figure 2 shows the difference
between CPB and HB blood parameters.
Parameter
Treat
Post
CPB
Hct
Non-HB
24.7 +/- 1.6
31.6 +/- 3.2
HB
24.3 +/- 2.1
34.5 +/- 2.3
Non-HB
*
2.7 +/- 7.4
HB
*
0.8 +/- 2.5
Non-HB
*
1.3 +/- 2.0
HB
*
0
Non-HB
*
1.7 +/- 3.1
HB
*
0.2 +/- 0.6
Non-HB
*
1.7 +/- 2.5
HB
*
0.4 +/- 1.3
Non-HB
*
1.0 +/- 3.2
HB
*
0.2 +/- 0.6
Non-HB
*
1039 +/- 613
HB
*
248 +/- 166
Non-HB
1.6 +/- 0.1
1.5 +/- 0.1
HB
1.6 +/- 0.3
1.4 +/- 0.1
Non-HB
19.2 +/- 0.8
17.7 +/- 1.4
HB
20.6 +/- 2.7
17.2 +/- 1.7
Non-HB
35 +/- 4
34 +/- 4
HB
38 +/- 9
32 +/- 7
Non-HB
195 +/- 42
239 +/- 76
HB
199 +/- 55
295 +/- 63
Non-HB
90 +/- 26
117 +/- 24
Dnr Exp
RBCs
Plt
FFP
Table 2 presents the results of the statistical analysis of the
differences between groups. Except for PTT, all parameters
changed significantly from the post-protamine and HB, ATS and
ANH blood infusion to approximately one hour after and arrival
in the ICU.
Cryo
ATS
INR
Figure 3 reports the cost savings by employing the Hemobag®.
Fibrinogen and Hct (Figure 4) were significantly higher in the
HB group at the end of the first ICU hour.
Significant reductions in PT and INR were also observed after
HB content infusion however, there was only a strong trend in
decreased average PTT. NHB patients required significantly
more donor blood products than the HB patients where nine of
the ten patients required no allogeneic blood during their
hospital stay.
Figure 2
PT
PTT
[Fib]
Plt Cnt
In
ICU
ICU
p
HB
p
Event
p
Interact
p
0.01
0.106
< 0.001
0.035
*
0.107
*
*
*
0.07
*
*
*
0.169
*
*
*
0.159
*
*
*
NS
*
*
0.001
*
*
NS
NS
0.021
NS
NS
NS
0.002
NS
NS
NS
NS
NS
0.044
0.122
0.001
NS
NS
NS
0.001
NS
HB
82 +/- 42
134 +/- 40
®
®
Note: Values are mean +/- one standard deviation. Hemobag effect is between the Hemobag (HB) and
non-HB groups. ICU is between HB and NHB in the ICU. Event is between post CPB and post one hour.
INR Changes Pre and & Post HB Savings of Unused Blood Products
& Blood Product Infusion
®
In the Hemobag Group
NS
NS
Post-Protamine
Post-Infusion
p = < 0.021
7 NHB pts. received blood products [FFP, Plt, Cryo, RBC]
1 HB pt. received blood products [FFP, Plt, Cryo,]
Discussion
Most allogeneic blood products are transfused in the first few
perioperative hours and often based upon arbitrary clinical
observations without adequate documentation of the need for
blood bank components (3).
The results of this case series strongly suggest that cardiac
surgery patients may be spared donor exposures when the
residual bypass circuit blood is highly concentrated and quickly
reinfused as compared to cell washing (9-10).
Use of the Hemobag® for salvaging blood is associated with
significant increases in the patient’s protein and cellular
concentrations, that would have normally been discarded
(average of costs of lost proteins +/- 4,000USD) (15) thus
lowering coagulation times in the important, first few hours
following CPB (11-14).
Use of “multi-pass” ultrafiltration (UF) to process the residual
perfusion circuit blood far exceeds the results of “single-pass”
ultrafiltration methods. This technique has improved our blood
administration practices and helped avoid many unnecessary
transfusions.
The Hemobag® patients obtained significantly improved
coagulation parameters with far fewer blood products than were
required in the non-HB patients. The Hemobag® provides
patients with improved quality of care through the reduction of
allogeneic blood products. Frequently, transfusions are directly
related to costly, negative, patient outcomes and in many cases
can be avoided (20).
The Hemobag® now offers perfusionists a new role in optimizing
homeostasis & coagulation in the first few critical hours after the
termination of cardiopulmonary bypass.
Hct% Pre and & Post HB Infusion
p = 0.010
NS
HB: p = 0.106
Post-Protamine
p = < 0.001
Figure 4
Fibrinogen Pre and & Post
®
Hemobag Infusion
p = 0.044
Figure 3
All blood products
®
for the Hemobag
patients’ charges
$1,722 vs. $12,563
for the control
patients.
A difference of:
$10,841
7 patients
Post-Infusion
HB: p = 0.122
NS
1 patient
Patient charges
ϰ2(1,
N=20) = 6.11, p < 0.025
Post-Protamine
p = < 0.001
Post-Infusion