Swedish Multicenter Trial of Outpatient Prevention of Leg Clots (StopLegClots)

Karolinska University Hospital

Status: Enrolling

Conditions: Achilles Tendon Rupture; Venous Thromboembolism; Ankle Fractures

Treatments: Device: Adjuvant IPC

Study type: Interventional

Funder types: Other

Identifiers

NCT03259204

2017-00202

Details and patient eligibility

About

Lower limb immobilization is associated with high risk of complications, i.e. venous thromboembolism (VTE) and failed healing. Pharmacoprophylaxis of VTE is in leg-immobilized patients, however, low- or non-effective and associated with adverse events. Thus, there is a need for novel treatments.

This study aims to demonstrate in leg immobilized patients who have suffered an ankle fracture (1000 patients) or an Achilles tendon rupture (400 patients) that adjuvant intermittent pneumatic compression (IPC) therapy, which targets impaired vascular flow, compared to treatment-as-usual with plaster cast, reduces VTE incidence and improves healing.

Full description

The proposed intervention, intermittent pneumatic compression (IPC) is an evidence-based prevention for VTE in hospitalized patients and used in daily practice. IPC is, however, not currently used on outpatients and it is currently unknown if it reduces the risk of VTE during long term leg-immobilization. Plaster cast and orthosis treatments are currently used in daily practice on Achilles tendon ruptures and ankle fractures. At present there is no consensus about using VTE prophylaxis in leg-immobilized patients. Since pharmacoprophylaxis has shown low- or no VTE preventive effects in leg-immobilization, is not recommended by some guidelines.

Furthermore, since all patients will undergo clinical examinations and have DVT-screening performed with compression Doppler ultrasound (CDU) removal of leg immobilization this will comprise an extra security for the included patients to detect a VTE. If a VTE is detected clinical guidelines will be followed by initiating chemical VTE-treatment.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute unilateral Achilles tendon rupture or isolated Ankle Fracture
• Treatment starts within 10 days in a hospital setting

Exclusion criteria

• Inability or refusal to give informed consent for participation in the study
• Inability to comply with the study instructions
• Known kidney disorder
• Heart failure with pitting oedema
• Presence of known malignancy
• Current bleeding disorder
• Pregnancy
• Planned follow-up at another hospital
• Pilon fracture

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,400 participants in 2 patient groups

Leg Immobilization

No Intervention group

Description:

Routine care include that the lower limb will be immobilized in an orthosis or a below-knee plaster cast according to local routines.

Adjuvant IPC

Experimental group

Description:

Leg Immobilization with the addition of IPC. Patients will during lower limb immobilization receive bilateral calf IPC.

Treatment:

Device: Adjuvant IPC