Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038454
Status:
SUSPENDED
Last Update Posted:
2005-06-24
First Post:
2002-05-30
Brief Title:
Phase II Study To Evaluate The Safety and Efficacy of Hemoglobin Raffimer in Patients Undergoing First Time CABG Surgery
Sponsor:
Hemosol
Organization:
Hemosol
Study Overview
Official Title:
A Phase II Randomized Single-Blind Controlled Clinical Trial to Evaluate the Efficacy and Safety of HemolinkTm o-Raffinose Cross-Linked Human Hemoglobin in Subjects Undergoing Primary Coronary Artery Bypass Grafting Surgery
Status:
SUSPENDED
Status Verified Date:
2003-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the efficacy of Hemolink in combination with Intraoperative Autologous Donation IAD versus control IAD alone in facilitating avoidance of allogeneic RBC transfusion during and following primary CABG surgery
Detailed Description:
All subjects who consent to take part in the protocol and who meet the inclusionexclusion criteria will undergo the IAD harvest following a post-induction IAD harvest calculation IAD blood will be collected into citrate-phosphate-dextrose-adenine 1 CPDA-1 blood bags All subjects will receive a volume of Hespan equal to the volume of their IAD harvest to a maximum of 1 liter performed as a result of the harvest calculation 0-1200 mL inclusive Additional volume replacement required owing to IAD 1000mL will be performed with crystalloid as required Subjects will be randomized into one of two treatment arms Hemolink arm or control arm upon meeting a transfusion trigger for the first time while on CPB Randomization will be administered centrally Subjects will be transfused upon reaching predetermined transfusion triggers reflecting a decrease in hemoglobin concentration andor oxygenation
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