3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE

Phase 4

Completed

• Conditions: Deep Vein Thrombosis; Pulmonary Embolism; Deep Vein Thrombosis With Pulmonary Embolism

• Registration Number: NCT00365950
• Lead Sponsor: British Thoracic Society

Brief Summary

To determine whether 3 months' anticoagulation is as good as or better than 6 months' for the treatment of DVT/PE

Detailed Description

Multi-centre trial involving 46 hospitals in the United Kingdom, with patients entered by 137 Consultant Physicians. Consenting patients were randomised in a central office to either 3 months' or 6 months' anticoagulation. Information on progress of the patients was requested by the co-ordinating office at 3 months, 6 months and 12 months. Outcomes were measured as death from DVT/PE, non-fatal extensions or recurrences of DVT/PE and major haemorrhages during and after anticoagulation.

Study Timeline

• Study Start: 1999-09
• Study Completion: 2003-12
• Status Verified: 2004-01
• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-17
• Last Update Submitted: 2006-08-17
• Study First Posted: 2006-08-18
• Last Update Posted: 2006-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

• Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate.

Exclusion Criteria

• DVT/PE severe enough to require thrombolysis or pulmonary embolectomy.
• DVT/PE in the preceding 3 years.
• Neoplasia diagnosed/treated within previous 3 years.
• Pregnancy.
• Known major thrombophilias.
• Prolonged or continuous immobility or confinement to bed.
• Previous allergy to heparin or warfarin.
• Requirement for long-term anticoagulation.
• Inability to give informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Death due to DVT/PE
Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment.
Number of major haemorrhages.

Secondary Outcome Measures

Name	Time	Method
Comparison of length of Hospital stay between those given unfractionated heparin and those given low molecular weight heparin.

Trial Locations

Locations (2)

Department of Chest Medicine, Llandough Hospital; 🇬🇧 Cardiff, Wales, United Kingdom

Department of Chest Medicine, Llandough Hospital,; 🇬🇧 Cardiff, Wales, United Kingdom