Early Surgery with Neuraxial Anaesthesia in Patients on Chronic Antiplatelet Therapy with a Proximal Femur Fracture: Multicentric Randomised Clinical Trial

Background: Patients with proximal femur fracture on antiplatelet treatment benefit from early surgery. Our goal was to perform early surgery under neuraxial anaesthesia when indicated by the platelet function test. Methods: We conducted a multicentre randomised open-label parallel clinical trial. P...

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Autores principales: Rafael Anaya, Mireia Rodriguez, Angélica Millan, Francesca Reguant, Jordi Llorca, Patricia Guilabert, Ana Ruiz, Percy-Efrain Pantoja, José María Gil, Victoria Moral, Angela Merchán-Galvis, Maria Jose Martinez-Zapata, on behalf of the AFFEcT Study Group
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Publicado: MDPI AG 2021
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Acceso en línea:https://doaj.org/article/f4c393ea056f45eaad31e7e38448b1f3
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spelling oai:doaj.org-article:f4c393ea056f45eaad31e7e38448b1f32021-11-25T18:02:12ZEarly Surgery with Neuraxial Anaesthesia in Patients on Chronic Antiplatelet Therapy with a Proximal Femur Fracture: Multicentric Randomised Clinical Trial10.3390/jcm102253712077-0383https://doaj.org/article/f4c393ea056f45eaad31e7e38448b1f32021-11-01T00:00:00Zhttps://www.mdpi.com/2077-0383/10/22/5371https://doaj.org/toc/2077-0383Background: Patients with proximal femur fracture on antiplatelet treatment benefit from early surgery. Our goal was to perform early surgery under neuraxial anaesthesia when indicated by the platelet function test. Methods: We conducted a multicentre randomised open-label parallel clinical trial. Patients were randomised to either early platelet function-guided surgery (experimental group) or delayed surgery (control group). Early surgery was programmed when the functional platelet count (as measured by Plateletworks) was >80 × 10<sup>9</sup>/L. The primary outcome was the emergency admission-to-surgery interval. Secondary outcomes were platelet function, postoperative bleeding, medical and surgical complications, and mortality. Results: A total of 156 patients were randomised, with 78 in each group, with a mean (SD) age of 85.96 (7.9) years, and 67.8% being female. The median (IQR) time to surgery was 2.3 (1.5–3.7) days for the experimental group and 4.9 (4.4–5.6) days for the control group. One-third of patients did not achieve the threshold functional platelet count on the first day of admission, requiring more than one test. There was no difference in clinical outcomes between groups. Conclusions: A strategy individualised according to the platelet function test shortens the time to proximal femur fracture surgery under neuraxial anaesthesia in patients on chronic antiplatelet treatment. Better powered randomised clinical trials are needed to further evaluate the clinical impact and safety of this strategy.Rafael AnayaMireia RodriguezAngélica MillanFrancesca ReguantJordi LlorcaPatricia GuilabertAna RuizPercy-Efrain PantojaJosé María GilVictoria MoralAngela Merchán-GalvisMaria Jose Martinez-Zapataon behalf of the AFFEcT Study GroupMDPI AGarticlefemur fractureantiplatelet drugsrandomized clinical trialMedicineRENJournal of Clinical Medicine, Vol 10, Iss 5371, p 5371 (2021)
institution DOAJ
collection DOAJ
language EN
topic femur fracture
antiplatelet drugs
randomized clinical trial
Medicine
R
spellingShingle femur fracture
antiplatelet drugs
randomized clinical trial
Medicine
R
Rafael Anaya
Mireia Rodriguez
Angélica Millan
Francesca Reguant
Jordi Llorca
Patricia Guilabert
Ana Ruiz
Percy-Efrain Pantoja
José María Gil
Victoria Moral
Angela Merchán-Galvis
Maria Jose Martinez-Zapata
on behalf of the AFFEcT Study Group
Early Surgery with Neuraxial Anaesthesia in Patients on Chronic Antiplatelet Therapy with a Proximal Femur Fracture: Multicentric Randomised Clinical Trial
description Background: Patients with proximal femur fracture on antiplatelet treatment benefit from early surgery. Our goal was to perform early surgery under neuraxial anaesthesia when indicated by the platelet function test. Methods: We conducted a multicentre randomised open-label parallel clinical trial. Patients were randomised to either early platelet function-guided surgery (experimental group) or delayed surgery (control group). Early surgery was programmed when the functional platelet count (as measured by Plateletworks) was >80 × 10<sup>9</sup>/L. The primary outcome was the emergency admission-to-surgery interval. Secondary outcomes were platelet function, postoperative bleeding, medical and surgical complications, and mortality. Results: A total of 156 patients were randomised, with 78 in each group, with a mean (SD) age of 85.96 (7.9) years, and 67.8% being female. The median (IQR) time to surgery was 2.3 (1.5–3.7) days for the experimental group and 4.9 (4.4–5.6) days for the control group. One-third of patients did not achieve the threshold functional platelet count on the first day of admission, requiring more than one test. There was no difference in clinical outcomes between groups. Conclusions: A strategy individualised according to the platelet function test shortens the time to proximal femur fracture surgery under neuraxial anaesthesia in patients on chronic antiplatelet treatment. Better powered randomised clinical trials are needed to further evaluate the clinical impact and safety of this strategy.
format article
author Rafael Anaya
Mireia Rodriguez
Angélica Millan
Francesca Reguant
Jordi Llorca
Patricia Guilabert
Ana Ruiz
Percy-Efrain Pantoja
José María Gil
Victoria Moral
Angela Merchán-Galvis
Maria Jose Martinez-Zapata
on behalf of the AFFEcT Study Group
author_facet Rafael Anaya
Mireia Rodriguez
Angélica Millan
Francesca Reguant
Jordi Llorca
Patricia Guilabert
Ana Ruiz
Percy-Efrain Pantoja
José María Gil
Victoria Moral
Angela Merchán-Galvis
Maria Jose Martinez-Zapata
on behalf of the AFFEcT Study Group
author_sort Rafael Anaya
title Early Surgery with Neuraxial Anaesthesia in Patients on Chronic Antiplatelet Therapy with a Proximal Femur Fracture: Multicentric Randomised Clinical Trial
title_short Early Surgery with Neuraxial Anaesthesia in Patients on Chronic Antiplatelet Therapy with a Proximal Femur Fracture: Multicentric Randomised Clinical Trial
title_full Early Surgery with Neuraxial Anaesthesia in Patients on Chronic Antiplatelet Therapy with a Proximal Femur Fracture: Multicentric Randomised Clinical Trial
title_fullStr Early Surgery with Neuraxial Anaesthesia in Patients on Chronic Antiplatelet Therapy with a Proximal Femur Fracture: Multicentric Randomised Clinical Trial
title_full_unstemmed Early Surgery with Neuraxial Anaesthesia in Patients on Chronic Antiplatelet Therapy with a Proximal Femur Fracture: Multicentric Randomised Clinical Trial
title_sort early surgery with neuraxial anaesthesia in patients on chronic antiplatelet therapy with a proximal femur fracture: multicentric randomised clinical trial
publisher MDPI AG
publishDate 2021
url https://doaj.org/article/f4c393ea056f45eaad31e7e38448b1f3
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