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TerminatedNCT00154427Updated Jan 12, 2017

Use of Activated Recombinant Human Factor VII in Cardiac Surgery

A Phase 2 interventional study of activated recombinant human factor VII in Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass, sponsored by Novo Nordisk A/S. Terminated at 63 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-12.

Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment

Why this study was terminated
Trial terminated after recruiting 172 patients but without proceeding to the highest dosing cohort as this no longer reflects common clinical practice
Phase
Phase 2
Study type
Interventional
Enrollment
172
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acquired Bleeding Disorder
  • Cardiac Surgery Requiring Cardiopulmonary Bypass
03

In context

Hemostatic Disorders

503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.

This study's enrollment of 172 is above the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Post-operative bleeding according to pre-defined criteria for critical bleeding
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
172 participants (actual)

Interventions

  • Drugactivated recombinant human factor VII
06

What researchers measure

Primary outcomes

  1. Incidence of critical, serious adverse events

    Time frame: Within 30 days

Secondary outcomes

  1. Surgical drainage volume

    Time frame: For the duration of the trial

  2. Amount of transfusions

    Time frame: For the duration of the trial

07

Study locations

63 sites
  • Novo Nordisk Investigational Site
    Birmingham, Alabama 35235, United States
  • Novo Nordisk Investigational Site
    Tucson, Arizona 85714, United States
  • Novo Nordisk Investigational Site
    San Francisco, California 94115, United States
  • Novo Nordisk Investigational Site
    Denver, Colorado 80262, United States
  • Novo Nordisk Investigational Site
    Atlanta, Georgia 30322, United States
  • Novo Nordisk Investigational Site
    Baltimore, Maryland 21287, United States
  • Novo Nordisk Investigational Site
    Boston, Massachusetts 02215, United States
  • Novo Nordisk Investigational Site
    Camden, New Jersey 08103, United States
  • Novo Nordisk Investigational Site
    Bronx, New York 10461, United States
  • Novo Nordisk Investigational Site
    Bronx, New York 10467, United States
  • Novo Nordisk Investigational Site
    Syracuse, New York 13210, United States
  • Novo Nordisk Investigational Site
    Cleveland, Ohio 44195, United States
  • Novo Nordisk Investigational Site
    Oklahoma City, Oklahoma 73117, United States
  • Novo Nordisk Investigational Site
    Portland, Oregon 97207, United States
  • Novo Nordisk Investigational Site
    Danville, Pennsylvania 17821, United States
  • Novo Nordisk Investigational Site
    Houston, Texas 77030, United States
  • Novo Nordisk Investigational Site
    Norfolk, Virginia 23507, United States
  • Novo Nordisk Investigational Site
    Richmond, Virginia 23298, United States
  • Novo Nordisk Investigational Site
    Buenos Aires, C1181ACH, Argentina
  • Novo Nordisk Investigational Site
    Caba, C1093AAS, Argentina
  • Novo Nordisk Investigational Site
    Capital Federal, 1209, Argentina
  • Novo Nordisk Investigational Site
    Corrientes, 3400, Argentina
  • Novo Nordisk Investigational Site
    Rosario, 2000, Argentina
  • Novo Nordisk Investigational Site
    São Paulo, 05403-000, Brazil
  • Novo Nordisk Investigational Site
    København ø, 2100, Denmark
  • Novo Nordisk Investigational Site
    NANTES Cedex 1, 44093, France
  • Novo Nordisk Investigational Site
    Vandoeuvre Les Nancy, 54511, France
  • Novo Nordisk Investigational Site
    Aachen, 52074, Germany
  • Novo Nordisk Investigational Site
    Berlin, 10117, Germany
  • Novo Nordisk Investigational Site
    Frankfurt/M., 60590, Germany
  • Novo Nordisk Investigational Site
    Krefeld, 47805, Germany
  • Novo Nordisk Investigational Site
    Köln, 50924, Germany
  • Novo Nordisk Investigational Site
    Leipzig, 04289, Germany
  • Novo Nordisk Investigational Site
    München, 80636, Germany
  • Novo Nordisk Investigational Site
    Ulm, 89075, Germany
  • Novo Nordisk Investigational Site
    Bangalore, 560 099, India
  • Novo Nordisk Investigational Site
    Chennai, 600 037, India
  • Novo Nordisk Investigational Site
    Chennai, 600101, India
  • Novo Nordisk Investigational Site
    New Delhi, 110025, India
  • Novo Nordisk Investigational Site
    Trivendrum, 695 011, India
  • Novo Nordisk Investigational Site
    Bologna, 40138, Italy
  • Novo Nordisk Investigational Site
    Milano, 20132, Italy
  • Novo Nordisk Investigational Site
    Roma, 00149, Italy
  • Novo Nordisk Investigational Site
    Roma, 00161, Italy
  • Novo Nordisk Investigational Site
    San Donato Milanese (MI), 20097, Italy
  • Novo Nordisk Investigational Site
    Kuala Lumpur, 50400, Malaysia
  • Novo Nordisk Investigational Site
    Singapore, 168752, Singapore
  • Novo Nordisk Investigational Site
    Johannesburg, Gauteng 2195, South Africa
  • Novo Nordisk Investigational Site
    Durban, KwaZulu-Natal 4001, South Africa
  • Novo Nordisk Investigational Site
    Cape Town, Western Cape 7550, South Africa
  • Novo Nordisk Investigational Site
    Barcelona, 08035, Spain
  • Novo Nordisk Investigational Site
    Bilbao, 48013, Spain
  • Novo Nordisk Investigational Site
    Madrid, 28006, Spain
  • Novo Nordisk Investigational Site
    Madrid, 28034, Spain
  • Novo Nordisk Investigational Site
    Madrid, 28046, Spain
  • Novo Nordisk Investigational Site
    Sevilla, 41013, Spain
  • Novo Nordisk Investigational Site
    Lund, 221 85, Sweden
  • Novo Nordisk Investigational Site
    Cambridge, CB3 8RE, United Kingdom
  • Novo Nordisk Investigational Site
    Leicester, LE3 9QP, United Kingdom
  • Novo Nordisk Investigational Site
    London, EC1A 7BE, United Kingdom
  • Novo Nordisk Investigational Site
    London, SW3 6NP, United Kingdom
  • Novo Nordisk Investigational Site
    London, W1G 8PH, United Kingdom
  • Novo Nordisk Investigational Site
    Southampton, SO16 6YD, United Kingdom
08

References and documents

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. doi: 10.1161/CIRCULATIONAHA.108.834275. Epub 2009 Jun 22. PubMed 19546387 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00154427
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 12, 2005
Start date
Aug 2004
Primary completion
Nov 2007
Completion
Nov 2007
Last update
Jan 12, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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