Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr David Warwick

ORCID ID

Contact details

Southampton University Hospitals NHS Trust
Department of Orthopaedic Surgery
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8079 6245
davidwarwick@handsurgery.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R/41/1.97/Warw

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular diseases: Thromboembolic disease

Intervention

1. Foot pump
2. Low molecular weight heparin

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/1995

Overall trial end date

31/12/1997

Reason abandoned

Eligibility

Participant inclusion criteria

300 consecutive primary Total Hip Replacement patients; randomised to have either Foot Pump or LMWH until discharge.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

290

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1995

Recruitment end date

31/12/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton University Hospitals NHS Trust
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/9730125

Publication citations

  1. Results

    Warwick D, Harrison J, Glew D, Mitchelmore A, Peters TJ, Donovan J, Comparison of the use of a foot pump with the use of low-molecular-weight heparin for the prevention of deep-vein thrombosis after total hip replacement. A prospective, randomized trial., J Bone Joint Surg Am, 1998, 80, 8, 1158-1166.

Additional files

Editorial Notes