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STUDY PROTOCOL
Year : 2018  |  Volume : 3  |  Issue : 4  |  Page : 113-119

Hemostasis following local versus intravenous tranexamic acid in patients undergoing posterior open reduction and internal fixation of thoracolumbar fractures: study protocol for a parallel-group, randomized controlled trial


Department of Orthopedics, the General Hospital of Western Theater Command, Chengdu, Sichuan Province, China

Correspondence Address:
Wei Zheng
Department of Orthopedics, the General Hospital of Western Theater Command, Chengdu, Sichuan Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-4157.248609

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Background and objectives: Local bleeding is relatively frequent during and after posterior open reduction and internal fixation of thoracolumbar fractures, with associated health risks. Both local and intravenous tranexamic acid have been shown to effectively reduce intraoperative blood loss, but the optimal method for achieving intraoperative hemostasis remains unclear. This study aims to compare hemostasis following local and intravenous tranexamic acid administration in patients undergoing posterior open reduction and internal fixation of thoracolumbar fractures. Design: A prospective, single-center, parallel-group, randomized controlled trial. Methods: This trial is conducted in 150 patients undergoing posterior open reduction and internal fixation of thoracolumbar fractures at the Department of Orthopedics, the General Hospital of Western Theater Command, China. The included patients are divided randomly and evenly into three groups (n = 50 per group). Patients in the intravenous administration group receive 100 mg/kg tranexamic acid dissolved in 100 mL normal saline intravenously 15 minutes before surgery; in the local administration group, the wound is flushed with a mixture of 10 mg/kg tranexamic acid and 50 mL normal saline before wound closure. Excess fluid is removed 10 minutes later using an aspirator and the wound is closed. Patients in the control group receive intravenous and local administration of normal saline. All patients are followed up at 1, 3, and 5 days after surgery. Outcome measures: The primary outcome measure is intraoperative blood loss, as a measure of intraoperative hemostasis. The secondary outcome measures are intraoperative blood transfusion, amount of drainage at postoperative days 1, 3, and 5, hemoglobin level, D-dimer level, international normalized ratio, prothrombin time, and activated partial thromboplastin time before surgery and at postoperative days 1, 3, and 5. Disscusion: This study compares hemostasis following local versus intravenous tranexamic acid administration in patients undergoing posterior open reduction and internal fixation of thoracolumbar fractures, to determine the optimal intraoperative hemostasis program for reducing surgical risk. Ethics and dissemination: This study has been approved by the Medical Ethics Committee of the General Hospital of Western Theater Command, China (approval No. 2015-keyan-03). The version of study protocol is 1.3. Patients and their family members should participate in this study voluntarily and written informed consent should be obtained from each patient. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Trial registration: This study protocol was registered with Chinese Clinical Trial Registry (registration number: ChiCTR-ICR-15006037) on January 26, 2015.


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