Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
University of Edinburgh Chief Scientist Office |
---|---|
Information provided by: | University of Edinburgh |
ClinicalTrials.gov Identifier: | NCT00789542 |
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.
Condition | Intervention | Phase |
---|---|---|
Stroke |
Device: Intermittant Pnueumatic compression |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Single Group Assignment |
Official Title: | A Randomised Trial to Establish the Effectiveness of Intermittent Pneumatic Compression to Prevent Post Stroke Deep Vein Thrombosis (DVT). |
Estimated Enrollment: | 2000 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | April 2014 |
Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
and
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.
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:
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
Contact: Gina Cranswick | 0131 5373126 | gina.cranswick@ed.ac.uk |
Contact: Janie Hunter | 0131 5373126 | janie.hunter@ed.ac.uk |
United Kingdom, Lothian | |
Western General Hospital | |
Edinburgh, Lothian, United Kingdom, EH4 2XU |
Principal Investigator: | Martin S Dennis, FRCP | University of Edinburgh |
Responsible Party: | University of Edinburgh ( Professor Martin Dennis ) |
Study ID Numbers: | 2008/W/NEU/12, ISRCTN93529999 |
Study First Received: | November 11, 2008 |
Last Updated: | November 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00789542 History of Changes |
Health Authority: | United Kingdom: National Health Service |
stroke deep vein thrombosis doppler |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases Cerebrovascular Disorders |
Thrombosis Embolism and Thrombosis Embolism Brain Ischemia Venous Thrombosis Brain Infarction Infarction |
Cerebral Infarction Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Brain Diseases Cerebrovascular Disorders |
Thrombosis Embolism and Thrombosis Brain Ischemia Venous Thrombosis Cardiovascular Diseases Brain Infarction |