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STOP leg clots-Swed...
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Svedman, SimonKarolinska Institutet
(författare)
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
- Artikel/kapitelEngelska2021
Förlag, utgivningsår, omfång ...
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2021-05-20
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BMJ Publishing Group Ltd,2021
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electronicrdacarrier
Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:uu-462048
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-462048URI
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https://doi.org/10.1136/bmjopen-2020-044103DOI
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https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-183939URI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:149036984URI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:149037603URI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
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Funding Agencies|Swedish research councilSwedish Research CouncilEuropean Commission [Dnr: 2017-00202]
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Introduction: Leg immobilisation in a cast or an orthosis after lower limb injuries is associated with a high risk of complications of venous thromboembolism (VTE) and hampered healing. Current pharmacoprophylaxes of VTE are inefficient and associated with adverse events. Intermittent pneumatic compression (IPC) could represent a novel, efficient and safe VTE-prophylactic alternative that may enhance injury healing. The aim of STOP leg clots is to assess the efficacy of adjuvant IPC-therapy on reduction of VTE incidence and improvement of healing in lower leg immobilised outpatients.Methods and analys: STOP leg clots is a multicentre randomised controlled superiority trial. Eligible patients (700 patients/arm) with either an acute ankle fracture or Achilles tendon rupture will be randomised to either addition of IPC during lower-leg immobilisation or to treatment-as-usual. The primary outcome will be the total VTE incidence, that is, symptomatic and asymptomatic deep venous thrombosis (DVT) or symptomatic pulmonary embolism (PE), during the leg immobilisation period, approximately 6-8 weeks. DVT incidence will be assessed by screening whole leg compression duplex ultrasound at removal of leg immobilisation and/or clinically diagnosed within the time of immobilisation. Symptomatic PE will be verified by CT.Secondary outcomes will include patient-reported outcome using validated questionnaires, healing evaluated by measurements of tendon callus production and changes in VTE-prophylactic mechanisms assessed by blood flow and fibrinolysis. Data analyses will be blinded and based on the intention-to-treat.
Ämnesord och genrebeteckningar
Biuppslag (personer, institutioner, konferenser, titlar ...)
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Alkner, Björn,1968-Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Department of Orthopaedics, Eksjö, Region Jönköping County, Sweden(Swepub:liu)bjoal31
(författare)
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Berg, Hans EKarolinska Institutet
(författare)
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Domeij-Arverud, EricaKarolinska Institutet
(författare)
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Jonsson, Kenneth BUppsala universitet,Ortopedi,Uppsala Univ Hosp, Sweden(Swepub:uu)kennjons
(författare)
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Nilsson Helander, KatarinaSahlgrens Univ Hosp, Sweden
(författare)
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Ackermann, Paul WKarolinska Institutet
(författare)
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Karolinska InstitutetAvdelningen för kirurgi, ortopedi och onkologi
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:BMJ Open: BMJ Publishing Group Ltd11:52044-6055
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