Swedish Multicenter Trial of Outpatient Prevention of Leg Clots
- Conditions
- Ankle FracturesVenous ThromboembolismAchilles Tendon Rupture
- Interventions
- Device: Adjuvant IPC
- Registration Number
- NCT03259204
- Lead Sponsor
- Karolinska University Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1400
- Acute unilateral Achilles tendon rupture or isolated Ankle Fracture
- Treatment starts within 10 days in a hospital setting
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adjuvant IPC Adjuvant IPC Leg Immobilization with the addition of IPC. Patients will during lower limb immobilization receive bilateral calf IPC.
- Primary Outcome Measures
Name Time Method Venous Thromboembolic Events (VTE) Up til the time of removal of leg immobilization, approx. 6-8 weeks The primary outcome is VTE defined as symptomatic Deep venous Thrombosis (DVT) or asymptomatic DVTs,or symptomatic pulmonary embolism
- Secondary Outcome Measures
Name Time Method Patient reported Outcome - EQ-5D-5L 6 months and 1 year symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D-5L).
Health economic analyses 2 years Together with Karolinska Institutet, LIME, the trial treatment effects will involve a within-trial evaluation of cost effectiveness integrated into a decision-analytic model of longer run costs and health effects
Patient reported Outcome - ATRS 6 months and 1 year symptoms will be assessed using the reliable and valid score; the Achilles tendon Total Rupture Score (ATRS)
Patient reported Outcome - FAOS 6 months and 1 year symptoms will be assessed using the reliable and valid score; the Foot and Ankle Outcome Score (FAOS)
Patient reported Outcome - OMAS 6 months and 1 year symptoms will be assessed using the reliable and valid score; the Olerud-Molander Ankle Score (OMAS)
Functional outcome - muscular endurance tests (heel-rise) 1 year Patient leg function will be measured by a validated endurance test (i.e. the heel-rise test) at 1 year post-injury.
Patient mortality 1year and 2 years Mortality of patients included will be recorded and investigated for cause of death. If the cause of death is VTE, this will be reported. The overall mortality rate in this study is expected to be low. Mortality will be investigated via patient journals at one year after study inclusion, and at 2 years via national mortality register.
Incidence of VTE in patients using low molecular weight heparin(LMWH) with or without adjvant IPC 6-8 weeks Efficacy of LMWH with and without the use of IPC as to prevent VTE will be studied in order to confirm the efficency of a commonly used drug for VTE prophylaxis.
VTE-preventive mechanisms 6 weeks VTE-preventive mechanisms will be analyzed at the 6 week visit by assessments of profibrinolysis and coagulation factors as well as by blood-flow quantification .
Callus production 6 weeks Microdialysis followed by quantification of procollagens will assess callus production in Achilles tendon healing.
Trial Locations
- Locations (1)
Karolinska University Hospital
🇸🇪Stockholm, Sweden