Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Bleeding and Cardiac Surgery, Allogeneic Blood Transfusion, Aortic Valve Replacement, Coronary Artery Bypass Graft Surgery

Intervention / Treatment
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* Drug: aprotinin or tranexamic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aprotinin or tranexamic acid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours postoperative drainage blood loss |  |  | 
| incidence of allogeneic blood transfusion |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| activation of fibrinolysis and hemostasis |  |  | 
| impairment of renal function |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aprotinin, cardiac surgery, blood transfusion, antifibrinolytics, tranexamic acid