Swedish Multicenter Trial of Outpatient Prevention of Leg Clots
NCT ID: NCT03259204
Last Updated: 2024-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1400 participants
INTERVENTIONAL
2018-09-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
No interventions assigned to this group
Adjuvant IPC
Leg Immobilization with the addition of IPC. Patients will during lower limb immobilization receive bilateral calf IPC.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Treatment starts within 10 days in a hospital setting
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Danderyd Hospital
OTHER
Stockholm South General Hospital
OTHER
Uppsala University Hospital
OTHER
Gävle Hospital
OTHER
Höglandssjukhuset Eksjö
UNKNOWN
Norrtälje Hospital
UNKNOWN
Östersund Hospital
UNKNOWN
Helsingborgs Hospital
OTHER
Uddevalla Hospital
UNKNOWN
Norra Älvsborgs Länssjukhus
UNKNOWN
Istituto Ortopedico Rizzoli
OTHER
Lugano Regional Hospital
UNKNOWN
Alingsås Lasarett
UNKNOWN
University Hospital, Akershus
OTHER
Karolinska University Hospital
OTHER
Responsible Party
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Paul Ackermann
Professor, MD, PhD
Principal Investigators
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Paul W Ackermann, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital, 171 76 Stockholm, SWEDEN
Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Official study site
Other Identifiers
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2017-00202
Identifier Type: -
Identifier Source: org_study_id
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