A randomised clinical trial to compare the AV impulse foot pump with low molecular weight Heparin in the prevention of deep vein thrombosis after total hip replacement
| ISRCTN | ISRCTN17418323 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17418323 |
| Protocol serial number | R/41/1.97/Warw |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South West (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 22/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr David Warwick
Scientific
Scientific
Southampton University Hospitals NHS Trust
Department of Orthopaedic Surgery
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 8079 6245 |
|---|---|
| davidwarwick@handsurgery.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Without prophylaxis, 45% of patients develop a deep vein thrombosis (DVT) after total hip replacement (THR). Prophylaxis is mandatory to reduce this potentially fatal complication. Low molecular weight heparin (LMWH) is well-established as the most effective method available, reducing the rate to 19% but carrying a perceived risk of haemorrhagic complications. The AV Impulse Foot Pump is a promising new device. Early reports (three relatively small randomised studies) report a DVT rate of 7 to 13%, without haemorrhagic complications. LMWH has not been directly compared with the Foot Pump. A large randomised study is required to determine which of these two prophylactic measures is most effective against DVT, with least complications, best patient acceptability and most favourable cost-benefit ratio. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular diseases: Thromboembolic disease |
| Intervention | 1. Foot pump 2. Low molecular weight heparin |
| Intervention type | Other |
| Primary outcome measure(s) |
The prevalence of deep-vein thrombosis, as determined by venography on the sixth, seventh, or eighth postoperative day. |
| Key secondary outcome measure(s) |
1. Transfusion requirements |
| Completion date | 31/12/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 290 |
| Key inclusion criteria | 300 consecutive primary Total Hip Replacement patients; randomised to have either Foot Pump or LMWH until discharge. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1995 |
| Date of final enrolment | 31/12/1997 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Southampton University Hospitals NHS Trust
Southampton
SO16 6YD
United Kingdom
SO16 6YD
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/08/1998 | Yes | No |
