Does intermittent pneumatic compression reduce the risk of post stroke deep vein thrombosis? The CLOTS 3 trial: study protocol for a randomized controlled trial
Key result
CLOTS 3 evaluates intermittent pneumatic compression to reduce proximal DVT in immobile stroke patients.
- n=2,800
Why the study?
There are no preventive strategies clearly shown to be both effective and safe for reducing proximal deep vein thrombosis in immobile stroke patients.
Does intermittent pneumatic compression added to best medical care reduce the risk of proximal deep vein thrombosis in immobile stroke patients?
Population
2800 immobile stroke patients within 3 days of hospital admission in the U.K
Comparison
Best medical care plus intermittent pneumatic compression vs best medical care alone
Design
Parallel group multicentre randomized controlled trial with centralized minimization and single-blind ultrasonographers
Follow-up
6 months
Authors
Discussion
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Member takes
Implication
Leaves open whether intermittent pneumatic compression reduces proximal DVT in immobile stroke; CLOTS 3 RCT will test this.
Study Design
Type
RCT (n=2,800)
Blinding
Single-blind
Randomization
Centralized minimization
Multicenter
Yes
Structured PICO
Does intermittent pneumatic compression added to best medical care reduce the risk of proximal deep vein thrombosis in immobile stroke patients?
P
Population
2,800 immobile patients admitted within 3 days of an acute stroke, planned to be followed for 6 months to assess the risk of deep vein thrombosis.
I
Intervention
Intermittent pneumatic compression added to best medical care
C
Comparator
Best medical care alone
O
Outcome
Symptomatic or asymptomatic deep vein thrombosis in the popliteal or femoral veins detected on Compression Duplex Ultrasound Scan at about 7-10 days and 25-30 dayscomposite
The CLOTS 3 trial protocol outlines a large-scale randomized study to evaluate the efficacy of intermittent pneumatic compression for preventing deep vein thrombosis in immobile stroke patients.
Limitations
- Imperfect blinding of the ultrasonographers which could bias detection of the primary outcome
- Inability to blind patients and caregivers which might bias assessment of secondary outcomes
- Lack of screening logs
- Lack of central verification of negative scans or 100% source data verification
Cite This Study
Dennis et al. (2012) conducted an RCT in Acute stroke with immobility (n=2,800). Intermittent pneumatic compression vs. Best medical care alone was evaluated on Symptomatic or asymptomatic deep vein thrombosis in the popliteal or femoral veins detected on compression duplex ultrasound scan or confirmed on imaging within 30 days. The CLOTS 3 trial is a planned randomized controlled trial designed to determine whether intermittent pneumatic compression reduces the risk of proximal deep vein thrombosis in immobile stroke patients.