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Use of NovoSeven® in Cardiac Surgery - Article


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Cardiac Rehabilitation

Clinical Trial: Use of NovoSeven® in Cardiac Surgery

This study is currently recruiting patients.
Verified by Novo Nordisk September 2005

Sponsored by: Novo Nordisk
Information provided by: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00154427

Purpose

This trial is conducted in Europe.

The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.

Condition Intervention Phase
Post-operative bleeding following cardiac surgery
  Drug: Activated recombinant human factor VII (NovoSeven®)
 Phase II

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Bleeding in Patients Following Cardiac Surgery.

Further Study Details: 
Primary Outcomes: Incidence of critical, serious adverse events within 30 days.
Secondary Outcomes: Amount of transfusions; Surgical drainage volume
Expected Total Enrollment:  210

Study start: October 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Post-operative bleeding according to pre-defined criteria for critical bleeding.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00154427

Public Access to Clinical Trials - Novo Nordisk.      Please contact NN via email:    clinicaltrials@novonordisk.com

Denmark
      Rigshospitalet, Hjertecentret, Copenhagen,  Denmark; Recruiting

France
      Hospital Laennec, Nantes,  France; Recruiting

Germany
      Klinik für Anästhesie und Operative Intensivmedizin, Berlin,  Germany; Recruiting

Italy
      Policlinico San Donato, San Donato Milanese,  Italy; Recruiting

Spain
      Hospital Ramon y Cajal, Madrid,  Spain; Recruiting

Sweden
      Lund University Hospital, Lund,  Sweden; Recruiting

United Kingdom
      Southampton General Hospital, Southampton,  United Kingdom; Recruiting

Study chairs or principal investigators

Mark Dowling,  Study Director,  Novo Nordisk Limited   

More Information

Study ID Numbers:  F7CARD-1610; Eudract No. 2004-000100-40
Last Updated:  September 9, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00154427
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Sweden: Medical Products Agency; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Denmark: Danish Medicines Agency; Germany: Paul-Ehrlich-Institut
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005


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Page Updated: November 5, 2004
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