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Use of Activated Recombinant Human Factor VII in Cardiac Surgery

This study has been terminated.
(Trial terminated after recruiting 172 patients but without proceeding to the highest dosing cohort as this no longer reflects common clinical practice)
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00154427
First received: September 9, 2005
Last updated: June 15, 2012
Last verified: February 2012
  Purpose

This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA).

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
Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass
Drug: activated recombinant human factor VII
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomised, Double-blind, Placebocontrolled, Dose Escalation Trial on Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Post-operative Bleeding in Patients Following Cardiac Surgery Requiring Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of critical, serious adverse events [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgical drainage volume [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • Amount of transfusions [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Enrollment: 172
Study Start Date: August 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-operative bleeding according to pre-defined criteria for critical bleeding
  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: NCT00154427

  Show 26 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Charlotte Born Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00154427     History of Changes
Other Study ID Numbers: F7CARD-1610, 2004-000100-40
Study First Received: September 9, 2005
Last Updated: June 15, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Singapore: Health Sciences Authority
Denmark: Danish Medicines Agency
South Africa: Medicines Control Council
Germany: Paul-Ehrlich-Institut
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Brazil: National Health Surveillance Agency
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Sweden: Medical Products Agency
India: Ministry of Health
United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Malaysia: Ministry of Health

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemorrhage
Hemostatic Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014