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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00154427
First received: September 9, 2005
Last updated: January 11, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Surgical drainage volume [ Time Frame: For the duration of the trial ]
  • Amount of transfusions [ Time Frame: For the duration of the trial ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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 63 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00154427     History of Changes
Other Study ID Numbers: F7CARD-1610
2004-000100-40 ( EudraCT Number )
Study First Received: September 9, 2005
Last Updated: January 11, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017