Anticoagulation of Calf Thrombosis (ACT): A Pilot Feasibility Study

Completed

• Conditions: Calf thrombosis/below knee DVT; Circulatory System; Other venous embolism and thrombosis

• Registration Number: ISRCTN75175695
• Lead Sponsor: Central Manchester NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. All ambulatory outpatients presenting to Manchester Royal Infirmary Emergency department diagnosed with below knee calf vein thrombosis by vascular ultrasound scan (USS)
2. Able to give informed consent
3. Aged 16-90

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined incidence of thrombus propagation above knee or development of pulmonary embolism during the 3 months randomisation period

Secondary Outcome Measures

Name	Time	Method
1. Incidence of major and minor bleeding episodes<br>2. Incidence of post thrombotic leg syndrome at 2 years using validated screening tool <br>3. Incidence of DVT recurrence at 2 years