THromboprophylaxis In Sickle Cell Disease with central venous catheters (THIS): an internal pilot randomised controlled trial protocol
Rattachement africain : ca, us, fr. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
INTRODUCTION: Individuals with sickle cell disease (SCD) and central venous catheters (CVC) are at high risk for venous thromboembolism (VTE). Minimal data exist regarding the use of anticoagulation as thromboprophylaxis of VTE in this demographic, and as a result, clinical equipoise exists. Prophylactic dose rivaroxaban, a direct oral anticoagulant, is efficacious and safe as thromboprophylaxis in other demographics, and may be an optimal agent in SCD with CVC. Prior to conducting a full clinical trial to assess rivaroxaban as thromboprophylaxis in SCD with CVC, a pilot study is needed to gauge its feasibility. METHODS AND ANALYSIS: THromboprophylaxis In Sickle Cell Disease pilot trial is an investigator-initiated, multicentre, double-blinded, randomised controlled trial (RCT) assessing if it is feasible and safe to conduct an adequately powered RCT comparing rivaroxaban to matching placebo as thromboprophylaxis in those with SCD and CVC. Fifty adult patients with SCD and CVC will be randomised to receive either rivaroxaban 10 mg daily or matching placebo for the duration of the CVC in situ for up to 1 year. After randomisation, follow-up visits will occur every 3 months. The primary outcomes pertain to the feasibility of a full trial and include numbers of eligible and recruited participants. Exploratory outcomes include overall incidence of VTE and bleeding complications, as well as quality of life. If the full trial is feasible, blinding will be maintained and patients in the pilot study will be included in the full trial. ETHICS AND DISSEMINATION: The trial was initially approved by the University Health Network Research Ethics Board (REB) in Toronto, Canada. All sites will obtain approval from their respective REB prior to commencement of study activities. Study results will be disseminated through presentations at medical conferences and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05033314.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- THromboprophylaxis In Sickle Cell Disease with central venous catheters (THIS): an internal pilot randomised controlled trial protocol
- Date Crossref
- 01/01/2024
- Éditeur
- BMJ
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Toronto Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Centre Hospitalier de l’Université de Montréal Department of Medicine pays non établi dans la noticeÉtablissement de santé
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3M (United States) pays non établi dans la noticeEntreprise
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Institute for Work & Health pays non établi dans la noticeOrganisation à but non lucratif
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Western University pays non établi dans la noticeUniversité ou école supérieure
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Institute for Transfusion Medicine pays non établi dans la noticeÉtablissement de santé
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University of Alberta Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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Assistance Publique – Hôpitaux de Paris pays non établi dans la noticeÉtablissement de santé
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Division of Hematology pays non établi dans la noticeInstitution
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Dalla Lana School of Public Health Institute for Health Policy pays non établi dans la noticeUniversité ou école supérieure
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Institute for Health Policy pays non établi dans la noticeStructure de recherche
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Schulich School of Medicine and Dentistry Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
Department of Medicine — University of Toronto, Department of Medicine — Centre Hospitalier de l’Université de Montréal et 3M (United States), avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.