A RCT to Establish the Effectiveness of Intermittent Pneumatic Compression to Prevent Post Stroke DVT

Summary

Strokes occur when blood flow to part of the brain is interrupted. Patients are often bedbound for several days or weeks although if they survive, most will make some recovery. The lack of mobility encourages blood clots to form in the legs - so called deep venous thrombosis or DVT. About 10% of patients will develop these. Pieces of this clot may break off and can be carried by the bloodstream to the lungs. These clots, called pulmonary emboli, can stop the heart and can cause patients with stroke to die suddenly. A treatment which reduces the risk of DVT after surgery is intermittent pneumatic compression (IPC). Inflatable sleeves wrapped around the legs inflate at intervals squeezing blood up the legs, increasing the blood flow, and decreasing the likelihood of clots forming - at least that is the theory!. Although this sounds uncomfortable, most people actually quite like the sensation! There have been some small randomised trials of IPC in stroke patients, particularly those with intracerebral bleeding. However, these studies although encouraging have not provided enough information to persuade clinicians to use this treatment routinely in stroke units. The proposed study will include 2000 patients who have had a stroke and who have been admitted to a stroke unit.

Patients who cannot walk independently, and who are at greatest risk of DVT will be invited to join the study. If they agree they will be randomly allocated to having routine care plus IPC or just routine care. Patient in both groups will have routine ultrasound scans on their legs to detect DVTs. The study will establish whether IPC reduces the risk of DVT. This result could improve the outcome of many thousands of patients each year.

Conditions

• Stroke

Interventions

DEVICE

Intermittent Pneumatic compression

Thigh length sleeves applied to both legs from randomization to Day 30 (Day and night) whilst sitting and lying

OTHER

Routine care

Routine care which might include: early mobilization, adequate hydration, aspirin if ischemic stroke and graduated compression stockings according to local protocols.

Sponsors & Collaborators

• Chief Scientist Office of the Scottish Government

  collaborator OTHER_GOV

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Medtronic - MITG

  collaborator INDUSTRY

• University of Edinburgh

  lead OTHER

Principal Investigators

• Martin S Dennis, FRCP · University of Edinburgh

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-12-31

Primary Completion

2013-01-31

Completion

2013-03-31

Countries

• United Kingdom

Study Locations