Overview

This trial is active, not recruiting.

Conditions bleeding and cardiac surgery, allogeneic blood transfusion, aortic valve replacement, coronary artery bypass graft surgery
Treatment aprotinin or tranexamic acid
Phase phase 3
Sponsor German Heart Center
Start date January 2005
End date July 2006
Trial size 220 participants
Trial identifier NCT00396760, 1172/04

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 bleeding.Only patients undergoing first time CABG or first time aortic valve replacement are included in this study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

Measure
24 hours postoperative drainage blood loss
time frame:
incidence of allogeneic blood transfusion
time frame:

Secondary Outcomes

Measure
activation of fibrinolysis and hemostasis
time frame:
impairment of renal function
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - informed consent - Patients undergoing primary CABG or Aortic valve replacement surgery Exclusion Criteria: - Previous sternotomy - OPCAB surgery - urgent/emergency operation - Coumadin treatment - previous aprotinin exposure - preoperative renal impairment (Creatinine > 2 mg/dL) - patients refusing blood transfusions - no informed consent

Additional Information

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
Principal investigator Wulf Dietrich, MD, PhD
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-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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2006.
Information provided to ClinicalTrials.gov by German Heart Center.