Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT00396760|
Recruitment Status : Unknown
Verified November 2006 by German Heart Center.
Recruitment status was: Active, not recruiting
First Posted : November 7, 2006
Last Update Posted : November 7, 2006
|Condition or disease||Intervention/treatment||Phase|
|Bleeding and Cardiac Surgery Allogeneic Blood Transfusion Aortic Valve Replacement Coronary Artery Bypass Graft Surgery||Drug: aprotinin or tranexamic acid||Phase 3|
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-exploration.Antifibrinolytic 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 analysis.The 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||January 2005|
|Estimated Study Completion Date :||July 2006|
- 24 hours postoperative drainage blood loss
- incidence of allogeneic blood transfusion
- activation of fibrinolysis and hemostasis
- impairment of renal function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396760
|German Heart Center Munich|
|Munich, Germany, 80636|
|Principal Investigator:||Wulf Dietrich, MD, PhD||Department of Anesthesiology, German Heart Center Munich|