Use of recombinant activated Factor Seven in bleeding extracorporeal membrane oxygenation patients post cardiac surgery: a randomised prospective study

ISRCTN	ISRCTN98382551
DOI	https://doi.org/10.1186/ISRCTN98382551
Protocol serial number	N0012154243
Sponsor	Department of Health
Funder	Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr C Ng
Scientific

PICU
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Use of recombinant activated Factor Seven in bleeding extracorporeal membrane oxygenation patients post cardiac surgery: a randomised prospective study
Study objectives	Will an early use of Factor Seven (FVII): 1. Stop bleeding? 2. Reduce use of other blood products?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Extracorporeal membrane oxygenation (ECMO) patients post cardiac surgery
Intervention	1. Use of FVII 2. Placebo
Intervention type	Other
Primary outcome measure(s)	1. Amount of post-operative bleeding 2. Use of human blood products
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/03/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	40
Key inclusion criteria	Post cardiac surgery patients
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/2004
Date of final enrolment	31/03/2006

Great Ormond Street Hospital

London
WC1N 3JH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan