Status:
Trial 1 closed and results were published on 5/27/09. Trial 2 started 5/29/09. Trial 2 closed 2/29/09. Results in preparation.
Purpose:
Trial 1: To determine whether graduated compression stockings (GCS) reduce the risk of poststroke above-knee deep venous thrombosis (DVT).
Trial 2: To determine whether knee-length GCS are as effective as full-length GCS for DVT prophylaxis.
Interventions:
DVT prophylaxis
Category includes drug treatments and procedures evaluated for prevention of deep venous thrombosis (DVT) or pulmonary embolism after stroke. Includes anticoagulants, antiplatelet agents, compression stockings.
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Location(s):
Europe, Argentina, Australia, India, Canada, Mexico, Poland, Singapore
Year Started:
2001
Year Finished:
2009
Year Presented:
2008
Design:
Two-part, multicenter, randomized, partially blinded, controlled trial with a planned enrollment of 2000 patients in each trial.
Inclusion Criteria
Patients presenting within 7 days of stroke, who are not independently mobile, (i.e. who are unable to get up and walk across the room), and who can be randomized within 3 days of hospital admission, are eligible for both studies.
Trial 1: Patients for whom the responsible clinician is unsure about the value of GCS are eligible for this study.
Trial 2: Patients requiring GCS for whom the responsible clinician is unsure of the optimum stocking length, are eligible for this study.
Exclusion Criteria
Patients who are unlikely to benefit from GCS, or who have a condition (e.g. peripheral vascular disease, diabetic, or sensory neuropathy) that the responsible clinician judges may pose a risk tissue necrosis, will be excluded from both studies.
Patient Involvement:
Trial 1: Eligible patients will be randomized to receive either full-length GCS or no GCS. Stockings should be applied immediately after randomization, and worn until the patient is either independently mobile or discharged from the hospital. Patients who wish to stop wearing GCS will be offered knee-length GCS. Patients in the no-GCS cohort should not wear stockings unless a situation develops that clearly indicates their use.
Trial 2: Eligible patients will be randomized to receive either full-length GCS or knee-length GCS. Guidelines for stocking application and compliance are the same as in Trial 1.
All patients in both trials will undergo Doppler ultrasound of both legs between days 7 and 10, and between days 25 and 30, in addition to receiving routine poststroke care throughout the study (e.g. aspirin, heparin, warfarin, or r-tPA, if there are no contraindications). Stockings will be removed the morning of the Doppler ultrasound procedures to ensure the blinding of the examiners. If a DVT is found, patients will be treated according to local protocol. Data regarding treatment, mortality, complications, and compliance will be collected at hospital discharge. At 5.5 months, a questionnaire will be sent to the patients' general practitioners, and at 6 months, the patients will be contacted by phone or by mail.
Primary Outcome:
Incidence at 30 days of DVT's in the popliteal or more proximal veins, detected on either Doppler ultrasound or venography.
Secondary Outcome:
Incidence at 7 days of DVT's in the popliteal or more proximal veins, death in conjunction with DVT at 30 days, all deaths at 6 months, deaths attributed to pulmonary embolism (PE) at 6 months, Modified Rankin Scale (MRS) score at 6 months, any complications of treatment, all DVT's at 30 days, asymptomatic DVT's at 30 days, all confirmed symptomatic DVT's, all confirmed symptomatic PE's, all leg swelling and/or leg ulcers at 6 months,
Results:
All patients were included in the analyses. The primary outcome occurred in 126 (10·0%) patients allocated to thigh-length GCS and in 133 (10·5%) allocated to avoid GCS, resulting in a non-significant absolute reduction in risk of 0·5% (95% CI −1·9% to 2·9%). Skin breaks, ulcers, blisters, and skin necrosis were significantly more common in patients allocated to GCS than in those allocated to avoid their use (64 [5%] vs 16 [1%]; odds ratio 4·18, 95% CI 2·40—7·27).
These data do not lend support to the use of thigh-length GCS in patients admitted to hospital with acute stroke. National guidelines for stroke might need to be revised on the basis of these results.
Source of Information:
CLOTS Trial Web Site. Presented at the 29th International Stroke Conference (February 2004. Presented at 12th European Stroke Conference (May 2003). Stroke 2004 35: e359 - e368
Abstract presentation @ 2008 International Stroke Conference (February 2008).
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