• Li-Min Zhang, Rui Li, Wen-Bo Sun, Xu-Peng Wang, Man-Man Qi, Yang Bai, Jing Bai, and Wei-Chao Zheng.
• Department of Anesthesiology, Cangzhou Central Hospital, Cangzhou, China. Electronic address: azai2010@126.com.
• World Neurosurg. 2019 Dec 1; 132: e21-e27.

BackgroundTo investigate role of Low-dose, Early Fresh frozen plasma Transfusion (LEFT) therapy in preventing perioperative coagulopathy and improving long-term outcome after severe traumatic brain injury (TBI).MethodsA prospective, single-center, parallel-group, randomized trial was designed. Patients with severe TBI were eligible. We used a computer-generated randomization list and closed opaque envelops to randomly allocate patients to treatment with fresh frozen plasma (5 mL/kg body weight; LEFT group) or normal saline (5 mL/kg body weight; NO LEFT group) after admission in the operating room.ResultsBetween January 1, 2018, and November 31, 2018, 63 patients were included and randomly allocated to LEFT (n = 28) and NO LEFT (n = 35) groups. The final interim analysis included 20 patients in the LEFT group and 32 patients in the NO LEFT group. The study was terminated early for futility and safety reasons because a high proportion of patients (7 of 20; 35.0%) in the LEFT group developed new delayed traumatic intracranial hematoma after surgery compared with the NO LEFT group (3 of 32; 9.4%) (relative risk, 5.205; 95% confidence interval, 1.159-23.384; P = 0.023). Demographic characteristics and indexes of severity of brain injury were similar at baseline.ConclusionsLEFT therapy was associated with a higher incidence of delayed traumatic intracranial hematoma than normal fresh frozen plasma transfusion in patients with severe TBI. A restricted fresh frozen plasma transfusion protocol, in the right clinical setting, may be more appropriate in patients with TBIs.Copyright © 2019 Elsevier Inc. All rights reserved.

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