NCT04290884

Tranexamic Acid in Chinese Elderly Patients With Intertrochanteric Fracture RCT

The Use of Tranexamic Acid in Chinese Elderly Patients Undergoing Femoral Nailing for Intertrochanteric Fracture: A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Hip fracture posed a major challenge to the health care system, with the one-year mortality of hip fracture reported as being approximately 20%. Perioperative haemoglobin level was associated with functional level of the patient and even mortality. Different methods for administration of tranexamic acid had been described. It was well established that systemic administration of tranexamic acid could reduce perioperative blood loss and transfusion rate. Topical administration had been shown to decrease blood loss and transfusion rate. The objective of our study is to investigate the hypothesis that tranexamic acid will reduce blood loss and transfusion rate in elderly patients undergoing hip fracture surgery.

Detailed description

The incidence of geriatric hip fractures is projected to increase by more than 250% in the next twenty-five years as the world population ages. Hip fracture in elderly patients are associated with significant morbidity and mortality. One of the significant morbidity is blood loss, which has been reported as high as 1500ml. Blood loss may lead subsequent blood transfusion. The rate of blood transfusion has been reported between 20 to 60%. Blood loss and subsequent blood transfusion could lengthen the overall hospital length of stay and delay the rehabilitation. Tranexamic acid, one of antifibrinolytic agents, is a synthetic derivative of the amino acid lysine and acts as a competitive inhibitor in the activation of plasminogen to plasmin, therefore preventing the degradation of fibrin. Shakur et al. reported that the use could reduce mortality in trauma patients. Tranexamic acid has been widely used in elective orthopaedic surgery such as total joint replacement and spine surgery. Several authors reported that tranexamic acid could decreases the blood loss, transfusion rate and cost.

Conditions

• Fracture of Femur

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	The recruited patients will be randomly assigned to two groups, 50% chance to the experimental group (use of tranexamic acid) and 50% chance to the control group (use of normal saline). After the reduction of the intertrochanteric fracture, 10ml of tranexamic acid is injected under the deep fascia around the fracture area before inserting a drain. As for the control group, 10ml of normal saline is injected instead. Blood will be taken on the third day post operation, and the patient will be seen at 6 weeks, and 3 months.

Timeline

• Start date: 2018-05-23
• Primary completion: 2020-02-14
• Completion: 2020-05-01
• First posted: 2020-03-02
• Last updated: 2020-03-19

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated drug study