A RCT to Establish the Effectiveness of Intermittent Pneumatic Compression to Prevent Post Stroke DVT "CLOTS-3"

Completed

Phase 3 Results N/A

Eligibility Criteria

Inclusion Criteria

- Any patient admitted to hospital within 3 days of a clinical stroke fulfilling the WHO criteria.
and
• Who is not able to get up from a chair/ out of bed and walk to the toilet without the help of another person
Patients can be randomised from Day 0 (day of admission) to Day 3 of hospital admission. If a patient has a stroke during a hospital admission they are eligible until Day 3 from the stroke onset (Day 0). Stroke should be the most likely clinical diagnosis but a visible infarction does not have to be seen on a brain scan.

Exclusion Criteria

- Patients with stroke due to subarachnoid haemorrhage. These are excluded because they are generally treated in neurology/neurosurgical centres, rather than stroke units, and their care often includes coiling or clipping of aneurysms under general anaesthetic. One could therefore argue that the existing evidence support the use of IPC in surgical patients is adequate to support its routine use in this group of patients.
- Patients who, in the opinion of the responsible clinician / nurse, are unlikely to benefit from Intermittent Pneumatic Compression - for instance those judged to have a very low risk of DVT. For instance, this would include patients who are expected to mobilise within the next day.
- Patients who are anticoagulated (taking Warfarin, unfractionated heparin, Low Molecular Weight Heparin or Direct thrombin inhibitors) at the time of enrolment in whom it is planned to continue the anticoagulation throughout the first week or two after the stroke. These patients are likely to have a very low risk of post stroke DVT and have little potential to benefit from either the IPC or participation in the CLOTS 3 trial. However, patients who may be started on anticoagulants after the first few days for reasons other than prophylaxis against VTE e.g. secondary prevention of ischaemic stroke with atrial fibrillation are eligible for enrolment.
- Patients with contraindications for the use of IPC. These include:
- patients with local leg conditions in which the IPC sleeves would interfere such as dermatitis, vein ligation (immediate postoperative), gangrene, venous stasis, or recent skin graft.
- patients with severe arteriosclerosis or other ischaemic vascular disease as indicated by absence of pedal pulses or history of definite intermittent claudication.
- patients who have massive leg oedema or pulmonary oedema from congestive heart failure.
- Patients who already have swelling or other signs of an existing DVT. Such patients may be recruited once a DVT has been excluded by normal D Dimers or Compression Doppler ultrasound.
- Patients under 16 year of age
Inclusion in another research study, including another randomised controlled trial, does not automatically exclude a patient from participating in CLOTS 3. As long as inclusion in the other study would not confound the results of CLOTS 3, co-enrolment is permissible. Also, local researchers must avoid overburdening patients. Patients should not be co-enrolled in another research study which aims to test an intervention which aims to reduce the risk of venous thromboembolism