Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada; Department of Obstetrics and Gynecology and Perinatal Medicine, The First I.M. Sechenov Moscow State Medical University, Moscow, Russia.
Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada.
J Thromb Haemost. 2024 Oct;22(10):2761-2766. doi: 10.1016/j.jtha.2024.07.002. Epub 2024 Jul 11.
It is uncertain whether prothrombin complex concentrate (PCC) improves hemostasis in patients on treatment with oral factor Xa-inhibitors (XaI) who require emergency surgery.
To evaluate whether, in patients with therapeutic levels of oral XaI, preoperative PCC prevents excessive bleeding during and after emergency surgery and is not associated with thrombotic complications.
We conducted a prospective cohort study wherein a fixed 2000 IU dose of 4-factor PCC was given to patients taking oral XaI with plasma XaI levels of at least 75 ng/mL before the emergency surgery with an expected blood loss of at least 50 mL. Patients were followed for 30 days. The primary efficacy outcome was the incidence of normal or mildly abnormal surgical hemostasis, as assessed by the surgeon; primary safety outcome was the incidence of thromboembolic events within 7 days.
We included 20 patients, of which 50% were female, on apixaban (75%) or rivaroxaban (25%) with median XaI level of 128 ng/mL (range, 77-497 ng/mL). The median duration of surgery was 2 hours 42 minutes (range, 15 minutes to 8 hours 17 minutes). Normal or mildly abnormal hemostasis was observed in 16 patients (80%); 2 patients had moderately abnormal and 2 had severely abnormal hemostasis, 1 each of those was considered due to local or technical factors. There were 4 deaths (20%) secondary to underlying disease and 1 incidental pulmonary embolism in a patient with cancer.
A fixed dose of PCC appears to control hemostasis in patients with therapeutic plasma levels of apixaban or rivaroxaban requiring emergency surgery.
对于正在接受口服因子 Xa 抑制剂（XaI）治疗且需要紧急手术的患者，使用凝血酶原复合物浓缩物（PCC）是否能改善止血效果尚不确定。
评估对于正在接受口服 XaI 治疗且血浆 XaI 水平至少为 75ng/ml 的患者，术前给予固定剂量的 2000IU 四因子 PCC 是否能防止紧急手术期间和之后的过度出血，且不会引起血栓并发症。
我们进行了一项前瞻性队列研究，在预计出血量至少为 50ml 的紧急手术前，对于正在接受口服 XaI 治疗且血浆 XaI 水平至少为 75ng/ml 的患者，给予固定剂量的 2000IU 四因子 PCC。患者随访 30 天。主要疗效终点为手术止血正常或轻度异常的发生率，由外科医生评估；主要安全性终点为术后 7 天内血栓栓塞事件的发生率。
我们纳入了 20 名患者，其中 50%为女性，服用阿哌沙班（75%）或利伐沙班（25%），XaI 水平中位数为 128ng/ml（范围，77-497ng/ml）。手术中位时间为 2 小时 42 分钟（范围，15 分钟至 8 小时 17 分钟）。16 名患者（80%）的止血效果正常或轻度异常；2 名患者中度异常，2 名患者严重异常，其中各 1 例被认为是局部或技术因素所致。4 名患者（20%）因基础疾病死亡，1 例癌症患者发生偶然的肺栓塞。
对于正在接受治疗且需要紧急手术的阿哌沙班或利伐沙班治疗的患者，使用固定剂量的 PCC 似乎能控制止血效果。
