NCT02253810

Efficacy of Tranexamic Acid for Reducing Blood Loss and Blood Transfusion After Periacetabular Osteotomy

The Effect of Intravenous Tranexamic Acid on Blood Loss and Transfusion After Periacetabular Osteotomy: a Prospective, Double-blinded, Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized controlled, double-blinded trial is to assess the efficacy of intravenous tranexamic acid, a drug, in reducing blood loss and transfusion in patients undergoing periacetabular osteotomy, an elective reorientation procedure for the hip joint. The investigators hypothesize that tranexamic acid will be more effective than placebo (normal saline solution) in reducing blood loss and transfusion after periacetabular osteotomy.

Detailed description

Periacetabular osteotomy (PAO) is an elective reorientation surgery for the hip joint, typically for the treatment of hip dysplasia in young, otherwise healthy patients, which requires multiple pelvic osteotomies around the acetabulum. A major source of its perioperative morbidity is blood loss. The principal cause of postoperative blood loss after PAO is surgical trauma, with secondary activation of both the coagulation cascade and local fibrinolysis. In the PAO literature, allogeneic transfusion rates are as high as 58%, and blood loss can range to nearly 4 L. The risk of excessive blood loss and blood transfusion in young, healthy patients after elective surgery is an event that can be reduced with blood conservation protocols, which can include pharmacological agents. Tranexamic acid is a synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen activation that interferes with fibrinolysis. Multiple studies and meta-analyses have shown that intravenous administration of the antifibrinolytic agent tranexamic acid reduces postoperative bleeding and the need for transfusion during joint replacement surgery. However, no published data exists to support its use during PAO. We hypothesize that intravenous tranexamic acid will reduce perioperative blood loss and, thus, transfusion requirement in patients undergoing PAO. A total of 80 patients will be enrolled. Patients will be randomized to receive either intravenous tranexamic acid versus placebo (normal saline) during PAO. Calculated total blood loss (primary outcome) will be determined, and intraoperative cell saver utilization (secondary outcome), and (3) postoperative allogeneic blood transfusion (secondary outcome) will be recorded. Patients will be followed for a total of 6 weeks after surgical intervention. If the use of IV tranexamic acid in the PAO patient population significantly reduces total perioperative blood loss, then it would provide an efficacious and inexpensive method for reducing postoperative morbidity after PAO.

Conditions

• Dysplasia, Congenital Hip

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Medication administered intra-operatively to promote blood clotting.
DRUG	Placebo	Saline solution

Timeline

• Start date: 2014-10-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2014-10-01
• Last updated: 2022-11-25
• Results posted: 2022-11-25

Locations

1 site across 1 country: United States