Low-Dose, Early Fresh Frozen Plasma Transfusion Therapy After Severe Trauma Brain Injury: A Clinical, Prospective, Randomized, Controlled Study
| Autor: | Wen-Bo Sun, Yang Bai, Jing Bai, Wei-Chao Zheng, Xu-Peng Wang, Rui Li, Li-Min Zhang, Man-Man Qi |
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| Rok vydání: | 2019 |
| Předmět: |
Male
Randomization Traumatic brain injury Intracranial hematoma law.invention 03 medical and health sciences Plasma 0302 clinical medicine Randomized controlled trial Double-Blind Method law Brain Injuries Traumatic Secondary Prevention Medicine Hematoma Subdural Acute Humans Blood Transfusion Prospective Studies Aged business.industry Glasgow Outcome Scale Perioperative Middle Aged medicine.disease Interim analysis Intracranial Hemorrhage Traumatic Treatment Outcome 030220 oncology & carcinogenesis Anesthesia Surgery Female Neurology (clinical) Fresh frozen plasma business Intracranial Hemorrhages 030217 neurology & neurosurgery Craniotomy |
| Zdroj: | World neurosurgery. 132 |
| ISSN: | 1878-8769 |
| Popis: | Background To 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). Methods A 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. Results Between 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. Conclusions LEFT 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. |
| Databáze: | OpenAIRE |
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