Swedish Multicenter Trial of Outpatient Prevention of Leg Clots

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    1400
  • sponsor
    Karolinska University Hospital
Updated on 26 January 2021
clot
fracture treatment
venous thromboembolism
achilles tendon rupture
ankle fracture
intermittent pneumatic compression

Summary

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.

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.

Details
Condition Fracture, Venous Thromboembolism, Thromboembolism, Achilles Tendon Rupture, Ankle Fracture, Ankle Fractures, Bone Fractures
Treatment Adjuvant IPC
Clinical Study IdentifierNCT03259204
SponsorKarolinska University Hospital
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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