Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425614
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-01-12
Brief Title:
COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry COLTRANE Trial
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Centrifugation-based Versus Filtration-based Intraoperative Cell Salvage on Quality of Perioperative Haemostasis in Cardiac Surgery A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLTRANE
Brief Summary:
Despite significant advances in patient blood management cardiac surgery remains a surgical procedure at high risk for bleeding Numerous perioperative blood conservation strategies have been developed for limiting the use of blood products Among them the processing of shed blood and residual cardiopulmonary bypass circuit volume with autotransfusion device is routinely used Conventional centrifugation-based autotransfusion devices actually available only recover red blood cells while platelets and coagulation factors are almost totally lost Consequently large amounts of intraoperative cell salvage could significantly alter perioperative haemostasis The SAME autotransfusion device i-SEP France is a new and innovative filtration-based autotransfusion device able to recover erythrocytes leukocytes but also platelets By offering the opportunity to re-infuse to patients their own platelets in addition red blood cells significantly improve perioperative haemostasis with this new device is expected The purpose of the COLTRANE trial is to compare the quality of the perioperative haemostasis in cardiac surgical patients for whom intraoperative cell salvage will be performed using either the SAME autotransfusion device or conventional centrifugation-based device
Because allogenic transfusion of blood products as well as surgical re-exploration for excessive bleeding are associated with poor outcomes and prolonged length of stay the use of filtration-based SAME device by maintaining perioperative haemostasis could improve outcomes and reduce length of stay of high risk patients The fact that patients receive their own platelets should also limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection
Because allogenic transfusion of blood products as well as surgical re-exploration for excessive bleeding are associated with poor outcomes and prolonged length of stay the use of filtration-based SAME device by maintaining perioperative haemostasis could improve outcomes and reduce length of stay of high risk patients The fact that patients receive their own platelets should also limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection
Detailed Description:
The SAME device is a new and innovative filtration-based autotransfusion device able to recover both erythrocytes and platelets A multicentre single-arm clinical feasibility and safety trial conducted by our group using SAME device on 50 cardiac surgical patients reported erythrocyte yield per cycle of 89 post-treatment hematocrit of 43 with an excellent washing performance In addition the device recovered 52 of platelets that were found unaltered by the device as demonstrated by a limited platelet activation and a strong response to thrombin-pathway stimulation assessed by flow cytometry By offering the opportunity to re-infuse to the patients their own platelets in addition to their RBC this new device might significantly improve perioperative haemostasis and thus decrease the need for blood products It is well established that severe postoperative bleeding and blood products transfusion lead to increase morbidity and mortality Consequently an improvement of postoperative outcomes and a decrease in intensive care unit ICU and hospital length of stay may be expected The fact that patients receive their own platelets should limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection Consequently a reduction of infectious complication may be also expected
The purpose of COLTRANE trial is to test the hypothesis that the intraoperative use of the filtration-based SAME autotransfusion device could improve perioperative haemostasis thereby reducing the proportion of patients exhibiting clinically significant perioperative bleeding moderate to massive bleeding according the Universal Definition of Perioperative Bleeding UDPB classification
The purpose of COLTRANE trial is to test the hypothesis that the intraoperative use of the filtration-based SAME autotransfusion device could improve perioperative haemostasis thereby reducing the proportion of patients exhibiting clinically significant perioperative bleeding moderate to massive bleeding according the Universal Definition of Perioperative Bleeding UDPB classification
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None