StopLegClots: Swedish Multicenter Trial of Outpatient Prevention of Leg Clots

Sponsor

Karolinska University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03259204

Collaborator

Sahlgrenska University Hospital, Sweden (Other), Danderyd Hospital (Other), Stockholm South General Hospital (Other), Uppsala University Hospital (Other), Region Örebro County (Other), Gävle Hospital (Other), Höglandssjukhuset Eksjö (Other), Norrtälje Hospital (Other), Östersund Hospital (Other), Helsingborgs Hospital (Other), Uddevalla Hospital (Other), Norra Älvsborgs Länssjukhus (Other), Istituto Ortopedico Rizzoli (Other), Lugano Regional Hospital (Other)

1,400

Enrollment

Location

Arms

Anticipated Duration (Months)

21.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Achilles Tendon Rupture Ankle Fractures Venous Thromboembolism	Device: Adjuvant IPC	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Prevention of Thromboembolism and Failed Healing During Lower Limb Immobilization - Multicenter Study With Adjuvant Intermittent Pneumatic Compression Therapy

Actual Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

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)
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).
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.
Callus production [6 weeks]
Microdialysis followed by quantification of procollagens will assess callus production in Achilles tendon healing.
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 .
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.