Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396760
Status:
UNKNOWN
Last Update Posted:
2006-11-07
First Post:
2006-11-06
Brief Title:
Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery
Sponsor:
German Heart Center
Organization:
German Heart Center
Study Overview
Official Title:
The Influence of High-Dose Aprotinin and Tranexamic Acid on Bleeding Tendency and Allogeneic Blood Transfusion in Patients Undergoing Primary Aortic Valve Replacement or Coronary Artery Revascularization
Status:
UNKNOWN
Status Verified Date:
2006-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
The hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid equally influence bleeding tendency and transfusion requirement in patients undergoing first time cardiac procedures with a low risk of increased postoperative bleedingOnly patients undergoing first time CABG or first time aortic valve replacement are included in this study
Detailed Description:
Excessive bleeding during and after cardiac surgery is a serious complication It exposes patients to the risk of allogeneic blood transfusion or other blood products and the risk of mediastinal re-explorationAntifibrinolytic drugs like aprotinin and tranexamic acid are proven to reduce bleeding tendency and transfusion requirement in cardiac surgery The efficacy of these drugs is proven especially for the unspecific proteinase inhibitor aprotinin however there are concerns about the safety and the high costs of this drug There are only limited head-to-head comparisons of these two drugs
In this double-blind prospective controlled study the efficacy of aprotinin and tranexamic acid is compared Primary outcome is the 24 hours postoperative drainage blood loss and the percentage of patients requiring allogeneic blood transfusion during the hospital stay Subgroups of patients undergoing CABG surgery or aortic valve replacement are predefined for combined and separate data analysisThe power of the study is calculated for this subgroup-analysis
Secondary outcome measurements are molecular marker of activation of hemostasis up to the 5th postoperative day
In this double-blind prospective controlled study the efficacy of aprotinin and tranexamic acid is compared Primary outcome is the 24 hours postoperative drainage blood loss and the percentage of patients requiring allogeneic blood transfusion during the hospital stay Subgroups of patients undergoing CABG surgery or aortic valve replacement are predefined for combined and separate data analysisThe power of the study is calculated for this subgroup-analysis
Secondary outcome measurements are molecular marker of activation of hemostasis up to the 5th postoperative day
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