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Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery

NCT ID: NCT00396760

Last Updated: 2006-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-07-31

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.

Conditions

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

Keywords

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cardiac surgery blood transfusion antifibrinolytics aprotinin tranexamic acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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aprotinin or tranexamic acid

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Heart Center

OTHER

Sponsor Role lead

Principal Investigators

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Wulf Dietrich, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, German Heart Center Munich

Locations

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German Heart Center Munich

Munich, Munich, Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1093/bja/aei044. Epub 2004 Dec 10.

Reference Type BACKGROUND
PMID: 15591329 (View on PubMed)

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. doi: 10.1002/14651858.CD001886.

Reference Type BACKGROUND
PMID: 11279735 (View on PubMed)

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. doi: 10.1213/01.ane.0000238447.74029.f5.

Reference Type BACKGROUND
PMID: 17056936 (View on PubMed)

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. doi: 10.1213/01.ane.0000238446.30034.c8.

Reference Type BACKGROUND
PMID: 17056935 (View on PubMed)

Lison S, Dietrich W, Braun S, Boehm J, Schuster T, Englhard A, Perchuc A, Spannagl M, Busley R. Enhanced thrombin generation after cardiopulmonary bypass surgery. Anesth Analg. 2011 Jan;112(1):37-45. doi: 10.1213/ANE.0b013e3181fc6df0. Epub 2010 Dec 2.

Reference Type DERIVED
PMID: 21127274 (View on PubMed)

Dietrich W, Spannagl M, Boehm J, Hauner K, Braun S, Schuster T, Busley R. Tranexamic acid and aprotinin in primary cardiac operations: an analysis of 220 cardiac surgical patients treated with tranexamic acid or aprotinin. Anesth Analg. 2008 Nov;107(5):1469-78. doi: 10.1213/ane.0b013e318182252b.

Reference Type DERIVED
PMID: 18931201 (View on PubMed)

Other Identifiers

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1172/04

Identifier Type: -

Identifier Source: org_study_id