Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment during cast immobilization of the lower leg. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment.

Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster cast immobilization following surgical or conservative treatment. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzanne C. Cannegieter, MD PhD
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Nadroparin

Criteria

Inclusion Criteria:

All patients in need of immobilization of the lower leg with a plaster cast (or equivalent of a cast) for a minimum of one week for the following indications:

• Trauma of the lower leg

• Surgery of the lower leg followed by lower leg immobilization with a plaster cast

• Non-traumatic indications

Exclusion Criteria:

• Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy)

• Pregnancy

• Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists.

• History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence)

• Mental of physical disability to fulfill study requirements

• Insufficient knowledge of the Dutch language

• Previous participation in the Pot-(K)Cast study