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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75175695
Enrollment
100
Registered
2010-12-03
Start date
2011-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calf thrombosis/below knee DVT Circulatory System Other venous embolism and thrombosis

Interventions

Patients will be randomised to one of the following treatment groups 1. Group A: conservative treatment (TED stockings and simple analgaesia) and full-dose anticoagulation, initiated with Low Molecula

Sponsors

Central Manchester NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Combined incidence of thrombus propagation above knee or development of pulmonary embolism during the 3 months randomisation period

Secondary

MeasureTime frame
1. Incidence of major and minor bleeding episodes 2. Incidence of post thrombotic leg syndrome at 2 years using validated screening tool 3. Incidence of DVT recurrence at 2 years

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 19, 2026