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 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 trial start date
01/01/1995
Overall trial end date
31/12/1997
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/9730125
Publication citations
-
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.