Anaya Rafael, Rodriguez Mireia, Millan Angélica, Reguant Francesca, Llorca Jordi, Guilabert Patricia, Ruiz Ana, Pantoja Percy-Efrain, Gil José María, Moral Victoria, Merchán-Galvis Angela, Martinez-Zapata Maria Jose
Anesthesiology Service, Hospital de la Santa Creu i Sant Pau, 08025 Barcelona, Spain.
Orthopedic and Traumatology Surgery Service, Hospital de la Santa Creu i Sant Pau, 08025 Barcelona, Spain.
J Clin Med. 2021 Nov 18;10(22):5371. doi: 10.3390/jcm10225371.
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.
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/L. The primary outcome was the emergency admission-to-surgery interval. Secondary outcomes were platelet function, postoperative bleeding, medical and surgical complications, and mortality.
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.
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.
接受抗血小板治疗的股骨近端骨折患者可从早期手术中获益。我们的目标是在血小板功能测试表明可行时,在神经轴麻醉下进行早期手术。
我们开展了一项多中心随机开放标签平行临床试验。患者被随机分为早期血小板功能引导手术组(试验组)或延迟手术组(对照组)。当功能性血小板计数(通过血小板功能分析仪测量)>80×10⁹/L时安排早期手术。主要结局是急诊入院至手术的间隔时间。次要结局包括血小板功能、术后出血、内科和外科并发症以及死亡率。
总共156例患者被随机分组,每组78例,平均(标准差)年龄为85.96(7.9)岁,女性占67.8%。试验组手术的中位(四分位间距)时间为2.3(1.5 - 3.7)天,对照组为4.9(4.4 - 5.6)天。三分之一的患者入院第一天未达到功能性血小板计数阈值,需要进行不止一次检测。两组临床结局无差异。
根据血小板功能测试进行个体化的策略可缩短接受慢性抗血小板治疗的患者在神经轴麻醉下进行股骨近端骨折手术的时间。需要开展样本量更大的随机临床试验来进一步评估该策略的临床影响和安全性。