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The Anticoagulation of Calf Thrombosis (ACT) project: study protocol for a randomized controlled trial
Daniel Horner1, Kerstin Hogg, Richard Body
1Emergency Department, Manchester Royal Infirmary, Central Manchester NHS Foundation Trust, Oxford Road, Manchester, UK. Danielhorner@nhs.net
Trials
|April 5, 2012
Summary
The Anticoagulation of Calf Thrombosis (ACT) trial is evaluating whether anticoagulation or conservative management is better for distal deep vein thrombosis (DVT). This pilot study will assess feasibility and collect data on outcomes like clot propagation and bleeding.
Area of Science:
- Vascular Medicine
- Clinical Trials
- Thrombosis Research
Background:
- Distal deep vein thrombosis (DVT) in calf veins is common in symptomatic patients.
- Current management for distal DVT is often conservative, but risks of propagation and post-thrombotic syndrome exist.
- Predicting outcomes for untreated distal DVT and balancing risks versus anticoagulation benefits remains challenging.
Purpose of the Study:
- To assess the feasibility of comparing therapeutic anticoagulation with conservative management for acute symptomatic distal DVT.
- To gather contemporary data on clot propagation, bleeding rates, and long-term outcomes in patients with distal DVT.
- To inform the design of a definitive clinical trial for distal DVT management.
Main Methods:
- A pragmatic, open-label, randomized controlled pilot trial comparing therapeutic anticoagulation and conservative management.
- Adult patients with acute distal DVT will be randomized.
- 3 months of blinded sonographic follow-up and 2-year final review will be conducted.
Main Results:
- Primary outcomes focus on feasibility endpoints for conducting a larger trial.
- Secondary outcomes include composite VTE events (propagation, PE, death), bleeding incidence, post-thrombotic syndrome, and VTE recurrence.
- Data collection aims to provide accurate rates for future study design.
Conclusions:
- The ACT trial will determine the feasibility of comparing anticoagulation and conservative management for distal DVT.
- Contemporary data on clinical outcomes will be provided.
- Results will guide the establishment of a definitive study if feasibility is demonstrated.
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