The Anticoagulation of Calf Thrombosis (ACT) Study: A randomised controlled trial comparing standardised anticoagulation versus conservative therapy in the treatment of below knee deep vein thrombosis. - Anticoagulation of Calf Thrombosis (ACT): A Pilot Feasibility Study

• Conditions: DVT of the calf / below knee region.; MedDRA version: 12Level: LLTClassification code 10013878Term: DVT of calf

• Registration Number: EUCTR2010-021813-22-GB
• Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-25
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All ambulatory outpatients presenting to Manchester Royal Infirmary Emergency department diagnosed with below knee calf vein thrombosis by vascular USS and able to give informed consent.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hospitalised patients.
Patients on long term anticoagulation.
Associated proximal DVT or confirmed PE.
Contraindication to anticoagulation (active bleeding, recent haemorrhagic CVA or upper GI bleed).
Other indication for immediate warfarinisation as per BSH guidelines: Prior confirmed and treated above knee DVT/PE, antiphospholipid syndrome, symptomatic inherited thrombophilia.
Pregnancy.
Chronic non propagating thrombus seen on prior USS.
Previous enrollment to the ACT study and achievement of the primary outcome.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified