Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0012154243
Study information
Scientific title
Use of recombinant activated Factor Seven in bleeding extracorporeal membrane oxygenation patients post cardiac surgery: a randomised prospective study
Acronym
Study hypothesis
Will an early use of Factor Seven (FVII):
1. Stop bleeding?
2. Reduce use of other blood products?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Extracorporeal membrane oxygenation (ECMO) patients post cardiac surgery
Intervention
1. Use of FVII
2. Placebo
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Amount of post-operative bleeding
2. Use of human blood products
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2004
Overall trial end date
31/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Post cardiac surgery patients
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/2004
Recruitment end date
31/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Great Ormond Street Hospital
London
WC1N 3JH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary