Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery

Coronary Artery Bypass Graft Surgery Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00396760
• Other study ID #: 1172/04
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 6, 2006
• Last updated: November 6, 2006
• Start date: January 2005
• Est. completion date: July 2006

Study information

• Verified date: November 2006
• Source: German Heart Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• aprotinin or tranexamic acid

Locations

Country	Name	City	State
Germany	German Heart Center Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
German Heart Center

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Dietrich W, Busley R, Kriner M. High-dose aprotinin in cardiac surgery: is high-dose high enough? An analysis of 8281 cardiac surgical patients treated with aprotinin. Anesth Analg. 2006 Nov;103(5):1074-81. — View Citation

Diprose P, Herbertson MJ, O'Shaughnessy D, Deakin CD, Gill RS. Reducing allogeneic transfusion in cardiac surgery: a randomized double-blind placebo-controlled trial of antifibrinolytic therapies used in addition to intra-operative cell salvage. Br J Anaesth. 2005 Mar;94(3):271-8. Epub 2004 Dec 10. — View Citation

Henry DA, Moxey AJ, Carless PA, O'Connell D, McClelland B, Henderson KM, Sly K, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2001;(1):CD001886. Review. Update in: Cochrane Database Syst Rev. 2007;(4):CD001886. — View Citation

Royston D, Levy JH, Fitch J, Dietrich W, Body SC, Murkin JM, Spiess BD, Nadel A. Full-dose aprotinin use in coronary artery bypass graft surgery: an analysis of perioperative pharmacotherapy and patient outcomes. Anesth Analg. 2006 Nov;103(5):1082-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hours postoperative drainage blood loss
Primary	incidence of allogeneic blood transfusion
Secondary	activation of fibrinolysis and hemostasis
Secondary	impairment of renal function