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

ClinicalTrials.gov Identifier:

NCT00154427

First received: September 9, 2005

Last updated: June 15, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

June 15, 2012

Start Date ^ICMJE

August 2004

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Incidence of critical, serious adverse events within 30 days.

Change History

Complete list of historical versions of study NCT00154427 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Surgical drainage volume
Amount of transfusions

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Use of Activated Recombinant Human Factor VII in Cardiac Surgery

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass

Intervention ^ICMJE

Drug: activated recombinant human factor VII

Study Arm (s)

Not Provided

Publications *

Gill R, Herbertson M, Vuylsteke A, Olsen PS, von Heymann C, Mythen M, Sellke F, Booth F, Schmidt TA. Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the setting of bleeding after cardiac surgery. Circulation. 2009 Jul 7;120(1):21-7. Epub 2009 Jun 22.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

172

Completion Date

November 2007

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Brazil, Denmark, France, Germany, India, Italy, Malaysia, Singapore, South Africa, Spain, Sweden, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00154427

Other Study ID Numbers ^ICMJE

F7CARD-1610, 2004-000100-40

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Charlotte Born

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top