Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation: Determining the Balance Between Benefits and Risks
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,500
- Locations
- 8
- Primary Endpoint
- Symptomatic deep venous thrombosis (DVT)
Study Overview
Brief 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.
Detailed Description
Background:
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 exists. In the proposed study we will use relevant symptomatic endpoints in a large cohort of patients. Furthermore we will follow subjects with an adverse event for a longer period, during which we will assess the long term sequelae of these events. Lastly, we will determine high risk groups that will benefit most from anticoagulant treatment.
Objective:
Comparative effectiveness research to determine cost-effectiveness of an existing healthcare policy, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster cast immobilization following surgical or conservative treatment. In addition we will investigate personalized prophylaxis based on genetic and acquired risk factors.
Study Design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LMWH
750 patients with lower leg cast immobilization will be randomized tot receive treatment with a LMWH.
Intervention: LMWH (Drug)
Outcomes
Primary Outcomes
Symptomatic deep venous thrombosis (DVT)
Time Frame: 3 Months
Symptomatic deep venous thrombosis confirmed with compression ultrasonography
Pulmonary Embolism (PE)
Time Frame: 3 months
Fatal or non-fatal pulmonary embolism confirmed with: * an intraluminal filling defect in segmental or more proximal branches on spiral CT scan, or * a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan, or * detected at autopsy
Major Bleeding
Time Frame: 3 months
Major bleeding, defined as: * a fatal bleeding, or * symptomatic bleeding in a critical area or organ, or * extrasurgical site bleeding causing a fall in hemoglobin level of 1.24mmol/L (2.0g/dL) or more, leading to transfusion of one or more units of whole blood or red cells, or * surgical site bleeding that requires a second intervention or a hemarthrosis interfering with rehabilitation, or surgical site bleeding that needs blood suppletion.
Secondary Outcomes
- Other clinically relevant bleeding(3 months)
- Surgical site infection(3 months)
Investigators
Suzanne C. Cannegieter, MD PhD
Study director
Leiden University