Edwards Gail, Roman Cristina, Jithoo Rondhir, Mitra Biswadev
Pharmacy Department, The Alfred Hospital, Melbourne, Australia.
Emergency & Trauma Centre, The Alfred Hospital, Melbourne, Australia.
Trauma Case Rep. 2017 Dec 29;13:46-49. doi: 10.1016/j.tcr.2017.12.003. eCollection 2018 Feb.
Idarucizumab is the first effective humanized monoclonal antibody fragment developed specifically as a reversal agent for dabigatran, a Direct Oral Anticoagulant. Despite recent trials demonstrating reversal of clinically relevant bleeding, there is a paucity of data on use outside the trial setting. This manuscript describes the use of Idarucizumab to reverse dabigatran in two patients presenting to the emergency department of a major tertiary hospital with acute traumatic subdural haematomas (SDH).
Patients were identified through retrospective review of medication dispensing systems and electronic medical records.
Two cases of Idarucizumab use were identified. Case 1 was of a 63-year-old male who presented following a motorcycle crash. Case 2 was of a 77-year-old male who presented with a 3-week history of ataxia and recurrent falls. Both patients were taking dabigatran for atrial fibrillation (AF). CT Brain revealed acute SDH with clinical indications for urgent surgical evacuation. Serum dabigatran levels were obtained on arrival in the emergency department with levels of 155 ng/ml and 110 ng/ml (reference range 117-275 ng/ml). Idarucizumab for dabigatran reversal was commenced; Case 1 received 5 g Idarucizumab as an intravenous bolus dose, while Case 2 received 5 g Idarucizumab as two 2.5 g intravenous infusions. Serum dabigatran levels for Cases 1 and 2 were 0 ng/ml at 75 min and 340 min post Idarucizumab administration respectively. Both patients proceeded to craniotomy with evacuation of the SDH. There was no extension of the SDH in either case. Anticoagulation was withheld until outpatient clinic review, and both patients transferred for rehabilitation prior to discharge home.
Idarucizumab was clinically effective for reversing dabigatran, resulting in undetectable serum levels, and should be considered in patients presenting to hospital with clinically significant bleeding associated with dabigatran therapy.
依达赛珠单抗是首个专门开发用于逆转直接口服抗凝剂达比加群作用的有效人源化单克隆抗体片段。尽管近期试验表明其可逆转临床相关出血，但关于试验环境以外的使用数据却很少。本手稿描述了在一家大型三级医院急诊科就诊的两名急性创伤性硬膜下血肿（SDH）患者中使用依达赛珠单抗逆转达比加群的情况。
通过回顾药物配给系统和电子病历确定患者。
确定了两例使用依达赛珠单抗的病例。病例1是一名63岁男性，因摩托车事故前来就诊。病例2是一名77岁男性，有3周共济失调和反复跌倒病史。两名患者均因心房颤动（AF）服用达比加群。脑部CT显示急性硬膜下血肿，有紧急手术清除的临床指征。患者到达急诊科时测定血清达比加群水平，分别为155纳克/毫升和110纳克/毫升（参考范围117 - 275纳克/毫升）。开始使用依达赛珠单抗逆转达比加群；病例1静脉推注5克依达赛珠单抗，病例2分两次静脉输注2.5克依达赛珠单抗，共5克。病例1和病例2在依达赛珠单抗给药后75分钟和340分钟时血清达比加群水平分别为0纳克/毫升。两名患者均进行了开颅手术清除硬膜下血肿。两例均未出现硬膜下血肿扩大。抗凝治疗暂停至门诊复查，两名患者在出院前转至康复机构。
依达赛珠单抗在临床上可有效逆转达比加群，使血清水平检测不到，对于因达比加群治疗出现临床显著出血而入院的患者应考虑使用。
