Prospective comparison of two carbon valve prostheses

ISRCTN	ISRCTN72276012
DOI	https://doi.org/10.1186/ISRCTN72276012
Protocol serial number	N0264073738
Sponsor	Department of Health (UK)
Funder	United Bristol Healthcare NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Alan Bryan
Scientific

c/o Research and Development Office
Level 1, Old Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom

Phone	+44 (0)117 928 3473

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Comparison of long-term clinical outcome with two bileaflet carbon prostheses.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Mechanical heart valve replacement
Intervention	Randomised prospective trial.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Death 2. Thromboembolic events 3. Bleeding 4. Valve dysfunction.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/02/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	485
Key inclusion criteria	Patients undergoing mechanical heart valve replacement.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/07/1993
Date of final enrolment	01/02/2005

c/o Research and Development Office

Bristol
BS2 8HW
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2002		Yes	No
Results article	results	01/03/2007		Yes	No