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The anticoagulation of calf thrombosis (ACT) project: results from the randomized controlled external pilot trial

Daniel Horner1, Kerstin Hogg2, Richard Body1

  • 1Emergency Department, The University of Manchester, Manchester, England.

Chest
|July 11, 2014
PubMed
Abstract

Insights

This pilot study found it feasible to research anticoagulation for isolated distal deep vein thrombosis (IDDVT). Anticoagulation may reduce serious VTE complications, warranting further investigation.

Area of Science:

  • Vascular Medicine
  • Thrombosis Research
  • Clinical Trial Design

Background:

  • Limited evidence exists on the clinical significance of isolated distal deep vein thrombosis (IDDVT).
  • International guidelines offer varying recommendations for IDDVT diagnosis and treatment.
  • The benefits of anticoagulation for IDDVT remain unquantified.

Purpose of the Study:

  • To assess the feasibility of conducting a randomized controlled trial for IDDVT.
  • To provide a primary outcome point estimate for a definitive study.
  • To evaluate the potential benefits of therapeutic anticoagulation in IDDVT patients.

Main Methods:

  • An open-label, external pilot randomized controlled trial was conducted.
  • Symptomatic, ambulatory patients with IDDVT were randomized to therapeutic anticoagulation or conservative management.
  • Patients underwent blinded duplex imaging and 3-month follow-up; intention-to-treat analysis was used.

Main Results:

  • Seventy of 93 eligible patients (88.6%) were recruited, with high follow-up rates.
  • The primary clinical outcome occurred in 11.4% of conservatively treated patients versus 0% in the anticoagulated group.
  • No major bleeding events were reported in either group.

Conclusions:

  • A definitive study on the value of therapeutic anticoagulation for IDDVT is feasible.
  • This study provides an estimated point for serious complications associated with a conservative approach.
  • Findings support further research into anticoagulation strategies for IDDVT.

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