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Use of recombinant activated Factor Seven in bleeding extracorporeal membrane oxygenation patients post cardiac surgery: a randomised prospective study
ISRCTN ISRCTN98382551
ClinicalTrials.gov identifier
Public title Use of recombinant activated Factor Seven in bleeding extracorporeal membrane oxygenation patients post cardiac surgery: a randomised prospective study
Scientific title
Acronym N/A
Serial number at source N0012154243
Study hypothesis Will an early use of Factor Seven (FVII):
1. Stop bleeding?
2. Reduce use of other blood products?
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Extracorporeal membrane oxygenation (ECMO) patients post cardiac surgery
Participants - inclusion criteria Post cardiac surgery patients
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/04/2004
Anticipated end date 31/03/2006
Status of trial Completed
Patient information material
Target number of participants 40
Interventions 1. Use of FVII
2. Placebo
Primary outcome measure(s) 1. Amount of post-operative bleeding
2. Use of human blood products
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)
Trial website
Publications
Contact name Dr  C  Ng
  Address PICU
Great Ormond Street Hospital
Great Ormond Street
  City/town London
  Zip/Postcode WC1N 3JH
  Country United Kingdom
Sponsor Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Fax +44 (0)20 7307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2005
Last edited 10/11/2011
Date ISRCTN assigned 30/09/2005
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