Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
01/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr C Ng

ORCID ID

Contact details

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

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes