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
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: 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

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
Email	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	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	The prevalence of deep-vein thrombosis, as determined by venography on the sixth, seventh, or eighth postoperative day.
Secondary outcome measures	1. Transfusion requirements 2. Intraoperative blood loss 3. Postoperative drainage 4. Blood-loss index 5. Appearance of the site of the wound according to a subjective visual-analogue scale 6. Swelling of the thigh.
Overall study start date	01/01/1995
Completion date	31/12/1997

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Southampton University Hospitals NHS Trust

Southampton
SO16 6YD
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	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	01/08/1998		Yes	No