Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by German Heart Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
German Heart Center
ClinicalTrials.gov Identifier:
NCT00396760
First received: November 6, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: November 6, 2006
Last Updated: November 6, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014