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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorAnaya, Rafael
dc.contributor.authorRodriguez, Mireia
dc.contributor.authorGil, José María
dc.contributor.authorMoral, Victoria
dc.contributor.authorMillan, Angélica
dc.contributor.authorVilalta, Noèlia
dc.contributor.authorGuilabert Sanz, Patricia
dc.contributor.authorBlanco Vargas, Domingo
dc.date.accessioned2019-07-05T07:34:17Z
dc.date.available2019-07-05T07:34:17Z
dc.date.issued2019-05
dc.identifier.citationAnaya R, Rodriguez M, Gil JM, Moral V, Millan A, Vilalta N, et al. Evaluation of a strategy to shorten the time to surgery in patients on antiplatelet therapy with a proximal femur fracture (AFFEcT Study): Study protocol for a multicenter randomized controlled clinical trial. Medicine (Baltimore). 2019; 98(19):e15514.
dc.identifier.issn0025-7974
dc.identifier.urihttp://hdl.handle.net/11351/4182
dc.descriptionFemur fracture; Platelet aggregation inhibitors; Clinical protocol
dc.description.abstractINTRODUCTION: Patients with femur fracture benefit from early surgery. Recent reports suggest that regional anesthesia may be superior to general anesthesia in these patients. Early surgery under spinal anesthesia could be performed safely by determining platelet function in patients receiving antiplatelet agents. METHODS: Multicenter, randomized, open-label, parallel clinical trial expected to include 156 patients ≥ 18 years of age under chronic treatment with antiplatelet agents who develop a proximal femur fracture. EXCLUSION CRITERIA: presence of multiple or pathological fractures, current treatment with vitamin K antagonists or new oral anticoagulants, and congenital or acquired coagulopathy.Patients will be randomized to eitherThe primary endpoint is time (hours) from admission to surgery. Secondary endpoints include: platelet function; postoperative bleeding; medical-surgical complications; perioperative and 1-year mortality; quality of life; length of hospital stay; cost-effectiveness; and cost-utility. Follow-up assessments will be performed during hospital admission and at 1, 6, and 12 months after surgery. POTENTIAL IMPACT OF THE STUDY: The determination of platelet function at admission to the emergency department in patients with femoral fracture receiving antiplatelet therapy may permit earlier surgery under spinal anesthesia, thus shortening the hospital stay and reducing the risk of complications. These advantages associated with early surgery could positively impact patient well-being and also reduce treatment-related healthcare costs. ETHICS AND DISSEMINATION: The study has been approved by the ethics committees at all participating centers. Their results will be disseminated in congresses and published in peer reviewed journals.
dc.language.isoeng
dc.publisherLippincott, Williams & Wilkins
dc.relation.ispartofseriesMedicine;98(19)
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceScientia
dc.subjectArticulació coxofemoral - Cirurgia
dc.subjectPlaquetes sanguínies - Agregació
dc.subjectPlaquetes sanguínies - Inhibidors
dc.subjectRaquianestèsia
dc.subjectAssaigs clínics
dc.subject.meshHip Fractures
dc.subject.mesh/surgery
dc.subject.meshPlatelet Aggregation Inhibitors
dc.subject.meshAnesthesia, Spinal
dc.subject.meshRandomized Controlled Trial
dc.titleEvaluation of a strategy to shorten the time to surgery in patients on antiplatelet therapy with a proximal femur fracture (AFFEcT Study): Study protocol for a multicenter randomized controlled clinical trial
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1097/MD.0000000000015514
dc.subject.decsfracturas de cadera
dc.subject.decs/cirugía
dc.subject.decsinhibidores de la agregación plaquetaria
dc.subject.decsanestesia raquídea
dc.subject.decsensayo clínico controlado aleatorizado
dc.relation.publishversionhttps://journals.lww.com/md-journal/fulltext/2019/05100/Evaluation_of_a_strategy_to_shorten_the_time_to.47.aspx
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Anaya R, Rodriguez M, Gil JM, Moral V] Servei d’Anestesiologia, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. [Millan A] Servei de Traumatologia i Cirurgia Ortopedica, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. [Vilalta N] Servei d’Hematologia, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. [Guilabert P, Blanco D] Servei d’Anestesiologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
dc.identifier.pmid31083195
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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