When it is possible to prove that there is a significant difference between the sequestration group and the other two groups, it also will be possible for patients with a smaller body surface to donate autologous blood and also this group will need…
ID
Source
Brief title
Condition
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Is there a decrease in use of allogeneic blood products in the sequestration
group?
Secondary outcome
Is there a decrease of blood loss in the sequestration group in regards to the
blood loss of the other two groups?
Background summary
Preoperative, during induction of anaesthesia, autologous blood is withdrawn
and afterward is given back after cardio-pulmonary-bypass (CPB), because of the
presumed benefit on haemostasis.
The consequence of the blood withdrawal before CPB is not seldom low Hematocrit
(Ht) during bypass and allogeneic red blood cells (RBC*s) need to be added to
gain a target level of Ht.
Transfusion of RBC*s could be avoided when sequestration of the autologous
blood is applied. During sequestration blood cells are separated from the
plasma.
The autologous RBC*s will be given back to the patient immediately after
withdrawing; the platelets and plasma can be given to the patient after CPB
cessation and protamine administration.
To examine the results of autologous blood withdrawal on patients with a normal
Hb/Ht a prospective, randomized study will be performed.
The hypothesis is that sequestration of autologous blood will result in less
transfusion of allogeneic blood products.
Primarily will be investigated the amount of allogeneic blood products
transfusion and the coagulation of the patient.
When the outcome will be positive: the treatment can be in the follow-up study
validated for the patient with a smaller body surface.
Study objective
When it is possible to prove that there is a significant difference between the
sequestration group and the other two groups, it also will be possible for
patients with a smaller body surface to donate autologous blood and also this
group will need also less allogeneic blood products.
Study design
There will be 3 groups of patients.
Each group will consist of 34 patients.
Group 1. autologous blood withdrawal.
Group 2. autologous blood withdrawal with sequestration.
Group 3. control group
In group 1 autologous blood is withdrawn during induction of anesthesia and is
given back to the patient after administration of protamine. Till that time it
will be kept on good condition on 37 degrees Celsius.
In group 2 autologous blood is withdrawn and sequestration will take place
immediately. After sequestration the RBC will be given back to the patient; the
plasma and platelets will be given back to the patient after CPB and will be
kept on a gentle shaker.
In group 3 there will be no withdrawing of autologous blood.
In all groups the rest volume will be handled the same with auto transfusion
apparatus as usually.
The volume what is declined is replaced by colloid solution.
Intervention
Group 1. autologous blood withdrawal and return transfusion.
Group 2. autologous blood withdrawal with sequestration and return transfusion.
Group 3. control group
Study burden and risks
Load:
Extra time to explain and inform the patient of this study and for signing the
informed consent.
Risk:
No extra risk.
's Gravendijkwal 230 / Postbus 2040
3015 CE ROTTERDAM / 3000 CA ROTTERDAM
Nederland
's Gravendijkwal 230 / Postbus 2040
3015 CE ROTTERDAM / 3000 CA ROTTERDAM
Nederland
Listed location countries
Age
Inclusion criteria
Adults age >= 18 year, undergoing openheartsurgery for CABG and or valve surgery
BSA > 170 dm2
Hemoglobin/Hematocrit >= 0,20 L/L
Exclusion criteria
Pre-operative Total Trombocytes < 120 x 109/L
Pre-operative increased liver enzymes: ASAT, ALAT, AF >= 2,5 x ULN
NYHA Class III and IV
Severe impaired renal function: Creatinine > 120 umol/l
Re operation
COPD
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL26000.078.08 |
Other | NTR candidate nummer 4740 |