NCT01252420

Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis

Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis (TWISTER)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Monash Medical Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a limited duration of treatment (two weeks of low molecular weight treatment) is a safe and effective treatment for distal deep vein thrombosis of the lower limb.

Detailed description

Approximately 50% of symptomatic episodes of deep vein thrombosis (DVT) will be confined to the calf veins (distal DVT). The proportion of distal DVT that propagate to the proximal veins, increasing the risk of pulmonary embolism, is not known. The best treatment of isolated distal DVT is therefore controversial and options include no treatment, follow-up scanning and treatment of only those patients with thrombus propagating to proximal veins, and full anticoagulation for periods ranging from 2 weeks to 3 months. There is good evidence that the 3-month thromboembolic risk in patients with a negative CUS that is limited to the proximal veins is low, in the order of 1%. Previous studies have demonstrated that patients treated with a short period of anticoagulation (4-6 weeks) have a low risk of developing recurrent DVT or PE. In addition, the specificity of CUS for distal DVT is lower than that for proximal DVT, increasing the proportion of false positive findings, making it likely that a proportion of patients diagnosed with distal DVT are treated unnecessarily, with the attendant risks of major and fatal haemorrhage. The need for anticoagulation of patients with distal DVT to prevent recurrent DVT is therefore uncertain, however a survey of current practice suggested that most patients with this condition currently receive antithrombotic therapy. The impact of anticoagulation on initial patient symptoms, and the subsequent risk of the post-thrombotic syndrome are also unclear, and may be a possible alternative justification for antithrombotic therapy. In this proposed multicentre, prospective, cohort study, we plan to determine if a shorter duration of anticoagulation (minimum 2 weeks) is a safe and effective treatment for isolated distal vein thrombosis.

Conditions

• Venous Thrombosis
• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Enoxaparin	1.5mg/kg daily for 2 weeks

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-11-01
• Completion: 2014-11-01
• First posted: 2010-12-03
• Last updated: 2010-12-06

Locations

4 sites across 2 countries: Australia, New Zealand