Effects of two different tranexamic acid administration methods on perioperative blood loss in total hip arthroplasty: study protocol for a prospective, open-label,randomized, controlled clinical trial / 中国组织工程研究

ABSTRACT

BACKGROUND: Reducing perioperative blood loss in total hip arthroplasty is a hot topic for joint surgeons. Both intravenous infusion and intra-articular injection of tranexamic acid significantly reduce perioperative blood loss, blood transfusion volume, and need for blood transfusion in patients undergoing total hip arthroplasty. However, differences between the intravenous and intra-articular methods are not clear.OBJECTIVE: To evaluate the effects of these two tranexamic acid administration methods on perioperative blood loss in patients undergoing total hip arthroplasty.METHODS: We are conducting a prospective, single-center, open-label, randomized, controlled clinical trial at the Tengzhou Central People's Hospital, China. Ninety patients undergoing unilateral total hip arthroplasty have been randomized into three groups. In the intravenous infusion group (n=30), 15 mg/kg tranexamic acid diluted in 100 mL physiological saline was infused intravenously at the beginning of surgery and 20 mL of physiological saline was injected intra-articularly after deep fascia suturing. In the intra-articular injection group (n=30), 100 mL of physiological saline was infused intravenously at the beginning of surgery and a mixture of 1.5 g tranexamic acid and 20 mL physiological saline was injected intra-articularly after deep fascia suturing. In the control group (n=30), 100 mL of physiological saline was infused intravenously at the beginning of surgery and 20 mL of physiological saline was injected intra-articularly after deep fascia suturing. The primary outcome is hidden blood loss at 1 and 3 days postoperatively. The secondary outcomes are visible blood loss, need for blood transfusion, and mean blood transfusion volume intraoperatively and on days 1 and 3 postoperatively. Other outcomes are the incidence of adverse reactions and complications within 3 months of surgery. The study protocol has been approved by the Ethics Committee of Tengzhou Central People's Hospital of China, approval number 2015-026. All protocols will be performed in accordance with the Ethical Principles for Medical Research Involving Human Subjects in the Declaration of Helsinki. Written informed consent was provided by each patient and their family members after they indicated that they fully understood the treatment plan.DISCUSSION: This trial was designed in April 2015. Cases were collected in July 2015. Data analysis will be finished in December 2017. This study is designed to investigate the effects of intravenous infusion versus intra-articular injection of tranexamic acid on perioperative blood loss in patients undergoing total hip arthroplasty to determine the more effective mode of administration.