Clinical trial NCT03259204: Swedish Multicenter Trial of Outpatient Prevention of Leg Clots
Official title: Prevention of Thromboembolism and Failed Healing During Lower Limb Immobilization - Multicenter Study With Adjuvant Intermittent Pneumatic Compression Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Achilles Tendon Rupture
Ankle Fractures
Venous Thromboembolism
Keywords: Achilles tendon
Microdialysis
Immobilization
Wound healing
Intermittent Pneumatic Compression
Ultrasonography
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Danderyd Hospital
name: Stockholm South General Hospital
name: Uppsala University Hospital
name: Gävle Hospital
name: Höglandssjukhuset Eksjö
name: Norrtälje Hospital
name: Östersund Hospital
name: Helsingborgs Hospital
name: Uddevalla Hospital
name: Norra Älvsborgs Länssjukhus
name: Istituto Ortopedico Rizzoli
name: Lugano Regional Hospital
name: Alingsås Lasarett
name: University Hospital, Akershus
First posted: 2017-08-23
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Venous Thromboembolic Events (VTE)
timeFrame: Up til the time of removal of leg immobilization, approx. 6-8 weeks
Secondary outcomes:
measure: Patient reported Outcome - ATRS
timeFrame: 6 months and 1 year
measure: Patient reported Outcome - FAOS
timeFrame: 6 months and 1 year
measure: Patient reported Outcome - OMAS
timeFrame: 6 months and 1 year
measure: Patient reported Outcome - EQ-5D-5L
timeFrame: 6 months and 1 year
measure: Functional outcome - muscular endurance tests (heel-rise)
timeFrame: 1 year
measure: Callus production
timeFrame: 6 weeks
measure: VTE-preventive mechanisms
timeFrame: 6 weeks
measure: Incidence of VTE in patients using low molecular weight heparin(LMWH) with or without adjvant IPC
timeFrame: 6-8 weeks
measure: Patient mortality
timeFrame: 1year and 2 years
measure: Health economic analyses
timeFrame: 2 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital, 171 76 Stockholm, SWEDEN
name: Paul W Ackermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arverud ED, Anundsson P, Hardell E, Barreng G, Edman G, Latifi A, Labruto F, Ackermann PW. Ageing, deep vein thrombosis and male gender predict poor outcome after acute Achilles tendon rupture. Bone Joint J. 2016 Dec;98-B(12):1635-1641. doi: 10.1302/0301-620X.98B12.BJJ-2016-0008.R1.
citation: Domeij-Arverud E, Ackermann PW. Deep Venous Thrombosis and Tendon Healing. Adv Exp Med Biol. 2016;920:221-8. doi: 10.1007/978-3-319-33943-6_21.
citation: Domeij-Arverud E, Labruto F, Latifi A, Nilsson G, Edman G, Ackermann PW. Intermittent pneumatic compression reduces the risk of deep vein thrombosis during post-operative lower limb immobilisation: a prospective randomised trial of acute ruptures of the Achilles tendon. Bone Joint J. 2015 May;97-B(5):675-80. doi: 10.1302/0301-620X.97B5.34581.
citation: Abdul Alim M, Domeij-Arverud E, Nilsson G, Edman G, Ackermann PW. Achilles tendon rupture healing is enhanced by intermittent pneumatic compression upregulating collagen type I synthesis. Knee Surg Sports Traumatol Arthrosc. 2018 Jul;26(7):2021-2029. doi: 10.1007/s00167-017-4621-8. Epub 2017 Jul 1.
citation: Svedman S, Alkner B, Berg HE, Domeij-Arverud E, Jonsson K, Nilsson Helander K, Ackermann PW. STOP leg clots-Swedish multicentre trial of outpatient prevention of leg clots: study protocol for a randomised controlled trial on the efficacy of intermittent pneumatic compression on venous thromboembolism in lower leg immobilised patients. BMJ Open. 2021 May 20;11(5):e044103. doi: 10.1136/bmjopen-2020-044103.