NCT00396760

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2006

Completed
Last Updated

November 7, 2006

Status Verified

November 1, 2006

First QC Date

November 6, 2006

Last Update Submit

November 6, 2006

Conditions

Bleeding and Cardiac SurgeryAllogeneic Blood TransfusionAortic Valve ReplacementCoronary Artery Bypass Graft Surgery

Keywords

cardiac surgeryblood transfusionantifibrinolyticsaprotinintranexamic acid

Outcome Measures

Primary Outcomes (2)

  • 24 hours postoperative drainage blood loss

  • incidence of allogeneic blood transfusion

Secondary Outcomes (2)

  • activation of fibrinolysis and hemostasis

  • impairment of renal function

Interventions

aprotinin or tranexamic acidDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent
  • Patients undergoing primary CABG or Aortic valve replacement surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Heart Center Munich

Munich, Munich, 80636, Germany

Location

Related Publications (6)

  • 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.

    PMID: 15591329BACKGROUND

  • 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.

    PMID: 11279735BACKGROUND

  • 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.

    PMID: 17056936BACKGROUND

  • 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.

    PMID: 17056935BACKGROUND

  • 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.

    PMID: 21127274DERIVED

  • 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.

    PMID: 18931201DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

AprotininTranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and ProteinsCyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Wulf Dietrich, MD, PhD

    Department of Anesthesiology, German Heart Center Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2006

First Posted

November 7, 2006

Study Start

January 1, 2005

Study Completion

July 1, 2006

Last Updated

November 7, 2006

Record last verified: 2006-11

Locations

DE(1)