Swedish Multicenter Trial of Outpatient Prevention of Leg Clots (StopLegClots)
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|ClinicalTrials.gov Identifier: NCT03259204|
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : October 7, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Achilles Tendon Rupture Ankle Fractures Venous Thromboembolism||Device: Adjuvant IPC||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||Prevention of Thromboembolism and Failed Healing During Lower Limb Immobilization - Multicenter Study With Adjuvant Intermittent Pneumatic Compression Therapy|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2023|
No Intervention: Leg Immobilization
Routine care include that the lower limb will be immobilized in an orthosis or a below-knee plaster cast according to local routines.
Experimental: Adjuvant IPC
Leg Immobilization with the addition of IPC. Patients will during lower limb immobilization receive bilateral calf IPC.
Device: Adjuvant IPC
This IPC-system delivers sequential circumferential compression. The IPC device is mobile and should therefore not restrict patient mobilization, but can be taken off if the patient wants to mobilize independently.
- Venous Thromboembolic Events (VTE) [ Time Frame: 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
- Patient reported Outcome - ATRS [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months and 1 year ]symptoms will be assessed using the reliable and valid score; the Olerud-Molander Ankle Score (OMAS)
- Patient reported Outcome - EQ-5D-5L [ Time Frame: 6 months and 1 year ]symptoms will be assessed using the reliable and valid score; EuroQol Group's questionnaire (EQ-5D-5L).
- Functional outcome - muscular endurance tests (heel-rise) [ Time Frame: 1 year ]Patient leg function will be measured by a validated endurance test (i.e. the heel-rise test) at 1 year post-injury.
- Callus production [ Time Frame: 6 weeks ]Microdialysis followed by quantification of procollagens will assess callus production in Achilles tendon healing.
- VTE-preventive mechanisms [ Time Frame: 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 .
- Incidence of VTE in patients using low molecular weight heparin(LMWH) with or without adjvant IPC [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259204
|Contact: Luigi Belcastro, RNfirstname.lastname@example.org|
|Contact: Simon Svedman, MD||Simon.email@example.com|
|Principal Investigator:||Paul W Ackermann, MD, PhD||Karolinska University Hospital, 171 76 Stockholm, SWEDEN|