Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176657
Status:
TERMINATED
Last Update Posted:
2007-05-01
First Post:
2005-09-13
Brief Title:
The Use of HEMOBAG to Salvage Blood After Cardiac Surgery
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Comparison of Whole Blood Return and Normal Practice Red Blood Cell Salvage Return Following Cardiopulmonary Bypass
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to attain sufficient numbers of subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The avoidance of blood transfusions benefits the patient Cardiopulmonary bypass CPB is routinely used in complex cardiac surgeries This device requires circulating blood through an oxygenator and pump while the heart is stopped Upon discontinuation of CPB the volume of blood in the CPB circuit approximately 1 to 15 liters is currently processed for the red cell components of the blood Yet all the other blood components are available in this volume of blood but are discarded The Hemobag filters allow for whole blood reinfusion rather than just red cell reinfusion Thus the patients own platelets for example are returned to the patient The product is just being used clinically and we the investigators at University of Medicine and Dentistry New Jersey have been asked to perform a study on our normal practice red blood cell return as described above compared to the whole blood return available with the Hemobag
Detailed Description:
The HemobagTM is a bag containing a microfilter for separation of autologous whole blood from intravenous solutions to provide a whole blood reinfusion from a cardiopulmonary bypass machine
Following cardiopulmonary bypass CPB blood remaining within the bypass machine circuit is normally processed by a centrifugal separation of fluids from red blood cells RBCs and the RBCs are reinfused back into the patient An FDA approved device the HemobagTM provides an alternative by reinfusing whole blood including RBCs from the CPB machine circuit This allows the patients own whole blood to be returned back to the patient with all components including functioning non-activated platelets coagulation factors and plasma In preliminary human trials blood measurements were improved in patients whose CPB blood was processed through the HemobagTM
This study will evaluate 50 patients whose post-CPB blood is processed by normal practice centrifugal separation of RBCs for reinfusion or HemobagTM whole blood reinfusion Outcome measurements will be chest tube drainage for the initial 24 hours following on-pump cardiac surgery ventilatory requirements protein levels transfusion requirements coagulation profile AA gradients arterial blood gas measures and CBC blood panels All of these data are available from the normal clinical care of the patient
The hypothesis is that the HemobagTM treated patients will have improved physiologic function from the return of whole blood rather than just RBCs following cardiac surgery using CPB
Following cardiopulmonary bypass CPB blood remaining within the bypass machine circuit is normally processed by a centrifugal separation of fluids from red blood cells RBCs and the RBCs are reinfused back into the patient An FDA approved device the HemobagTM provides an alternative by reinfusing whole blood including RBCs from the CPB machine circuit This allows the patients own whole blood to be returned back to the patient with all components including functioning non-activated platelets coagulation factors and plasma In preliminary human trials blood measurements were improved in patients whose CPB blood was processed through the HemobagTM
This study will evaluate 50 patients whose post-CPB blood is processed by normal practice centrifugal separation of RBCs for reinfusion or HemobagTM whole blood reinfusion Outcome measurements will be chest tube drainage for the initial 24 hours following on-pump cardiac surgery ventilatory requirements protein levels transfusion requirements coagulation profile AA gradients arterial blood gas measures and CBC blood panels All of these data are available from the normal clinical care of the patient
The hypothesis is that the HemobagTM treated patients will have improved physiologic function from the return of whole blood rather than just RBCs following cardiac surgery using CPB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None