Clinical trial NCT00154427: Use of Activated Recombinant Human Factor VII in Cardiac Surgery
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Incidence of critical, serious adverse events
timeFrame: Within 30 days
Secondary outcomes:
measure: Surgical drainage volume
timeFrame: For the duration of the trial
measure: Amount of transfusions
timeFrame: For the duration of the trial
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: San Francisco
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Denver
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Camden
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Bronx
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Bronx
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Syracuse
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Cleveland
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Danville
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Caba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Capital Federal
country: Argentina
facility: Novo Nordisk Investigational Site
city: Corrientes
country: Argentina
facility: Novo Nordisk Investigational Site
city: Rosario
country: Argentina
facility: Novo Nordisk Investigational Site
city: São Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
city: København ø
country: Denmark
facility: Novo Nordisk Investigational Site
city: NANTES Cedex 1
country: France
facility: Novo Nordisk Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: Novo Nordisk Investigational Site
city: Aachen
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt/M.
country: Germany
facility: Novo Nordisk Investigational Site
city: Krefeld
country: Germany
facility: Novo Nordisk Investigational Site
city: Köln
country: Germany
facility: Novo Nordisk Investigational Site
city: Leipzig
country: Germany
facility: Novo Nordisk Investigational Site
city: München
country: Germany
facility: Novo Nordisk Investigational Site
city: Ulm
country: Germany
facility: Novo Nordisk Investigational Site
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
city: New Delhi
country: India
facility: Novo Nordisk Investigational Site
city: Trivendrum
country: India
facility: Novo Nordisk Investigational Site
city: Bologna
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: Roma
country: Italy
facility: Novo Nordisk Investigational Site
city: San Donato Milanese (MI)
country: Italy
facility: Novo Nordisk Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Singapore
country: Singapore
facility: Novo Nordisk Investigational Site
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Novo Nordisk Investigational Site
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: Novo Nordisk Investigational Site
state: Western Cape
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Bilbao
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Lund
country: Sweden
facility: Novo Nordisk Investigational Site
city: Cambridge
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leicester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Southampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.