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

British Thoracic Society2,400 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,400

Conditions

Deep Vein Thrombosis Pulmonary Embolism Deep Vein Thrombosis With Pulmonary Embolism

Interventions

Duration of anticoagulationDRUG

Warfarin durationDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Department of Chest Medicine, Llandough Hospital

Cardiff, Wales, United Kingdom

Department of Chest Medicine, Llandough Hospital,

Cardiff, Wales, United Kingdom

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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