Related Experiment Video
Updated: May 13, 2026

A Multicenter MRI Protocol for the Evaluation and Quantification of Deep Vein Thrombosis
Published on: June 2, 2015
Does intermittent pneumatic compression reduce the risk of post stroke deep vein thrombosis? The CLOTS 3 trial:
Martin Dennis1, Peter Sandercock, Gordon Murray
1Division of Clinical Neurosciences, The University of Edinburgh, Western General Hospital, Crewe Road, Edinburgh EH4 2XU, UK. martin.dennis@ed.ac.uk
Insights
Intermittent pneumatic compression (IPC) significantly reduced deep vein thrombosis (DVT) risk in immobile stroke patients. This best medical care plus IPC approach offers a vital preventative strategy for stroke survivors, improving outcomes and quality of life.
Area of Science:
- Clinical Trials
- Vascular Medicine
- Neurology
Background:
- Venous thromboembolism (VTE) is a frequent and serious complication following stroke.
- Immobility post-stroke increases the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Purpose of the Study:
- To evaluate the efficacy of intermittent pneumatic compression (IPC) as an adjunct to best medical care in preventing proximal DVT in immobile stroke patients.
- To assess the impact of IPC on the incidence of symptomatic and asymptomatic DVT, as well as long-term outcomes like PE, functional status, and quality of life.
Main Methods:
- A multicenter, parallel-group randomized controlled trial (CLOTS 3) involving 2,876 immobile stroke patients within 3 days of admission.
- Patients received either best medical care or best medical care plus IPC.
- Compression Doppler ultrasound was used to detect DVT at 7-10 and 25-30 days post-randomization. Follow-up at 6 months assessed for symptomatic DVT, PE, functional outcome, and quality of life.
Main Results:
- The study aimed to detect a 4% absolute difference in DVT risk between groups, with over 90% power.
- Detailed statistical analysis plan for primary and secondary outcomes has been described.
Conclusions:
- Intermittent pneumatic compression (IPC) is a potentially effective intervention for preventing deep vein thrombosis (DVT) in immobile stroke patients.
- Further results will elucidate the definitive impact of IPC on VTE, functional outcomes, and quality of life in this vulnerable population.
Background:
Venous thromboembolism (VTE) is a common and important complication of stroke. The CLOTS 3 trial aims to determine whether, compared with best medical care, best medical care plus intermittent pneumatic compression (IPC) in immobile stroke patients reduces the risk of proximal deep vein thrombosis (DVT).
Methods/Design:
The CLOTS 3 trial is a multicenter, parallel group trial with centralized randomization (minimization) to ensure allocation concealment. The protocol has been published (Trials 2012, 13:26) and is available in full at: http://www.clotstrial.com. Between December 2008 and September 2012, 105 centers in the UK recruited 2,876 immobile stroke patients within the first 3 days of their hospital admission. Patients were allocated to best medical care or best medical care plus IPC. Ultrasonographers performed a compression Doppler ultrasound scan to detect DVT in each treatment group at 7 to 10 days and 25 to 30 days. The primary outcome cluster includes symptomatic or asymptomatic DVT in the popliteal or femoral veins detected on either scan. Patients will be followed up by postal or telephone questionnaire at 6 months from randomization to detect later symptomatic DVT and pulmonary embolism (PE), and to measure functional outcome (Oxford Handicap Scale) and quality of life (EQ-5D-3L). The ultrasonographers performing the scans are blinded to treatment allocation, whereas the patients and caregivers are not. The trial has more than 90% power to detect a 4% absolute difference (12% versus 8%) in risk of the primary outcome and includes a health economic analysis.Follow-up will be completed in April 2013 and the results reported in May 2013. In this update, we describe the statistical analysis plan.
Trial Registration:
ISRCTN: ISRCTN93529999.
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