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Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2006 by German Heart Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00396760
First Posted: November 7, 2006
Last Update Posted: November 7, 2006
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.
Information provided by:
German Heart Center
  Purpose
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 Intervention Phase
Bleeding and Cardiac Surgery Allogeneic Blood Transfusion Aortic Valve Replacement Coronary Artery Bypass Graft Surgery Drug: aprotinin or tranexamic acid Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by German Heart Center:

Primary Outcome Measures:
  • 24 hours postoperative drainage blood loss
  • incidence of allogeneic blood transfusion

Secondary Outcome Measures:
  • activation of fibrinolysis and hemostasis
  • impairment of renal function

Estimated Enrollment: 220
Study Start Date: January 2005
Estimated Study Completion Date: July 2006
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.

  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00396760


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00396760     History of Changes
Other Study ID Numbers: 1172/04
First Submitted: November 6, 2006
First Posted: November 7, 2006
Last Update Posted: November 7, 2006
Last Verified: November 2006

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

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