dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Anaya, Rafael |
dc.contributor.author | Rodriguez, Mireia |
dc.contributor.author | Gil, José María |
dc.contributor.author | Moral, Victoria |
dc.contributor.author | Millan, Angélica |
dc.contributor.author | Vilalta, Noèlia |
dc.contributor.author | Guilabert Sanz, Patricia |
dc.contributor.author | Blanco Vargas, Domingo |
dc.date.accessioned | 2019-07-05T07:34:17Z |
dc.date.available | 2019-07-05T07:34:17Z |
dc.date.issued | 2019-05 |
dc.identifier.citation | Anaya 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.issn | 0025-7974 |
dc.identifier.uri | https://hdl.handle.net/11351/4182 |
dc.description | Femur fracture; Platelet aggregation inhibitors; Clinical protocol |
dc.description.abstract | INTRODUCTION:
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.iso | eng |
dc.publisher | Lippincott, Williams & Wilkins |
dc.relation.ispartofseries | Medicine;98(19) |
dc.rights | Attribution 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ |
dc.source | Scientia |
dc.subject | Articulació coxofemoral - Cirurgia |
dc.subject | Plaquetes sanguínies - Agregació |
dc.subject | Plaquetes sanguínies - Inhibidors |
dc.subject | Raquianestèsia |
dc.subject | Assaigs clínics |
dc.subject.mesh | Hip Fractures |
dc.subject.mesh | /surgery |
dc.subject.mesh | Platelet Aggregation Inhibitors |
dc.subject.mesh | Anesthesia, Spinal |
dc.subject.mesh | Randomized Controlled Trial |
dc.title | 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 |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1097/MD.0000000000015514 |
dc.subject.decs | fracturas de cadera |
dc.subject.decs | /cirugía |
dc.subject.decs | inhibidores de la agregación plaquetaria |
dc.subject.decs | anestesia raquídea |
dc.subject.decs | ensayo clínico controlado aleatorizado |
dc.relation.publishversion | https://journals.lww.com/md-journal/fulltext/2019/05100/Evaluation_of_a_strategy_to_shorten_the_time_to.47.aspx |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut 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.pmid | 31083195 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |