Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
German Heart Center

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

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

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-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)
Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 24 hours postoperative drainage blood loss
  2. incidence of allogeneic blood transfusion

Secondary Outcome Measures :
  1. activation of fibrinolysis and hemostasis
  2. impairment of renal function

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00396760

German Heart Center Munich
Munich, Germany, 80636
Sponsors and Collaborators
German Heart Center
Principal Investigator: Wulf Dietrich, MD, PhD Department of Anesthesiology, German Heart Center Munich

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00396760     History of Changes
Other Study ID Numbers: 1172/04
First Posted: November 7, 2006    Key Record Dates
Last Update Posted: November 7, 2006
Last Verified: November 2006

Keywords provided by German Heart Center:
cardiac surgery
blood transfusion
tranexamic acid

Additional relevant MeSH terms:
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors