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 knee replacement
| ISRCTN | ISRCTN51028168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51028168 |
| Secondary identifying numbers | R/41/1.97/Warw |
- 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
- Surgery
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | What is the relative effectiveness (against deep vein thrombosis [DVT]), safety and cost of Low Molecular Weight Heparin and the AV Impulse Foot Pump after total knee replacement surgery? |
| Ethics approval(s) | Our study had the approval of the local Medical Research and Ethics Committee. |
| Health condition(s) or problem(s) studied | Total knee replacement |
| Intervention | Enoxaparin (40 mg) was administered, subcutaneously, 12 hours before surgery (in accordance with the UK licence) and every 24 hours thereafter until discharge from hospital. The slippers for the foot pump were applied in the recovery room and the controller was then engaged. The foot pump was then used whenever the patient was not weight-bearing until discharge from hospital. The patient lay in bed with the legs parallel to the floor. The controller activated the pump every 20 seconds at a pressure of 130 mmHg for a period of one second. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Enoxaparin |
| Primary outcome measure | Frequency of DVT as shown by the results of ipsilateral ascending venography between the sixth and eighth postoperative days. |
| Secondary outcome measures | 1. Perioperative blood loss: a single drain was used routinely and blood loss was derived from a summation of intraoperative blood loss and postoperative drainage at 36 hours 2. Haemoglobin and haematocrit: measured before operation, on the second day after surgery and just before discharge 3. Blood loss index: transfusion requirements of the patients were noted. We recorded whether or not the patient had bruising or oozing from the site of the wound on the fourth and seventh postoperative days. 4. Swelling: assessed by measuring the circumference of the thigh and calf at 10 cm above and below the joint, respectively on the fourth and seventh postoperative days. The level was marked by an indelible pen to maintain consistency. 5. Knee flexion: measured active knee flexion with a goniometer on the fourth and seventh postoperative days. The soft-tissue side-effects were assessed in an open-label manner as it was apparent whether or not the patient was using a foot pump. |
| Overall study start date | 01/08/1997 |
| Completion date | 01/02/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 229 |
| Key inclusion criteria | Patients scheduled for unilateral primary total knee replacement at the Avon Orthopaedic Centre. |
| Key exclusion criteria | 1. Refusal of consent 2. Long-term warfarin therapy for pre-existing cardiac or cerebral disease 3. A bleeding tendency 4. Painful joints or wounds in the feet which would preclude the use of the foot pump |
| Date of first enrolment | 01/08/1997 |
| Date of final enrolment | 01/02/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southampton University Hospitals NHS Trust
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South West (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/04/2002 | Yes | No |
