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RESEARCH ARTICLE
Year : 2019  |  Volume : 4  |  Issue : 1  |  Page : 17-23

Effects of intravenous tranexamic acid on bleeding during and after pelvic fracture surgery: protocol for a prospective, randomized, parallel-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: 10.4103/2542-4157.253725

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Background and objectives: Numerous studies have shown that tranexamic acid effectively reduces the amount of bleeding and drainage, and reduces the blood transfusion rate during and after various operations. The present study aims to investigate whether tranexamic acid effectively reduces the amount of bleeding during and after pelvic fracture surgery. Subjects and methods: This prospective, single-center, randomized, parallel-controlled trial includes 70 patients with pelvic fracture who received treatment from April 2015 to January 2017 at the Department of Orthopedics, General Hospital of Western Theater Command, China. These patients were randomly divided into a tranexamic acid group and a control group. Fifteen minutes prior to the skin incision, the tranexamic acid and control groups respectively received an intravenous infusion of 100 mL normal saline alone or with 10 mg/kg tranexamic acid. Patients were followed up at postoperative 1, 3, and 5 days. This study was approved by the Ethics Committee of the General Hospital of Western Theater Command on February 16, 2015 (approval No. 2015-keyan-04). All patients provided written informed consent for study inclusion. Data collection: April 1, 2015 to January 30, 2017; study completed: March 31, 2017; study status: completed with data analysis ongoing. Outcome measures: The primary outcome measure is intraoperative blood loss, as a measure of intraoperative hemostasis. The secondary outcome measures are intraoperative blood transfusion, drainage volume at postoperative 1, 3, and 5 days, and hemoglobin level, D-dimer level, international normalized ratio, prothrombin time, and activated partial thromboplastin time preoperatively and at postoperative 1, 3, and 5 days. Discussion: This study will provide evidence to validate whether intravenous tranexamic acid administered 15 minutes prior to pelvic fracture surgery reduces intra- and postoperative bleeding. Trial registration: This study protocol was registered with Chinese Clinical Trial Registry (registration number: ChiCTR-ICC-15006070) on March 13, 2015.


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