A comparison of the effects of rofecoxib and diclofenac on the PFA-100, a laboratory based indicator of platelet function, in a post-operative neurosurgical population
| ISRCTN | ISRCTN73370863 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73370863 |
| Protocol serial number | N0263111551 |
| Sponsor | Department of Health (UK) |
| Funder | University College London Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 19/07/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Haematological Disorders
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
Contact information
Dr Mary Newton
Scientific
Scientific
The National Hospital for Neurology and Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom
| Phone | +44 (0)20 7829 8711 |
|---|---|
| mary.newton@uclh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Does rofecoxib, a non-steroidal COX II inhibitor analgesic, cause less platelet dysfunction than diclofenac, a standard non-steroidal COX I inhibitor, in post-operative neurosurgical patients when used as analgesic adjuncts? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Platelet dysfunction |
| Intervention | 1. Rofecoxib 2. Diclofenac This trial was stopped in September 2003 due to participant recruitment issues. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rofecoxib, diclofenac |
| Primary outcome measure(s) |
Assessment of comparative effects of COX I/COX II inhibitors on platelet function using the platelet function analyser, the PFA-100, on blood samples taken from the participants. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2004 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key inclusion criteria | 30 Patients from Neurosurgery/NSITU. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/09/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The National Hospital for Neurology and Neurosurgery
London
WC1N 3BG
United Kingdom
WC1N 3BG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
