The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery

• Status: Completed
• Trial end date: 2017-07-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if patients undergoing acetabular ORIF (open reduction with internal fixation) who receive tranexamic acid have a reduced risk of allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for thromboembolic events compared to patients who receive placebo. Investigators want to determine the cost-effectiveness related to allogenic blood transfusion as a blood loss management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic surgery carries with it a significant risk for blood loss. Current management of perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse reactions. There have been significant efforts to reduce the use of allogenic blood transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been used in management of blood during surgery. In order to determine the impact of tranexamic acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will conduct a prospective randomized study. Patients undergoing acetabular surgery will be screened for this study. Patients will be then randomized to placebo or tranexamic acid which will be administered during and after surgery. The following data will be collected: patient characteristics, surgery information, blood loss, blood transfusions, wound complication within 30 days of surgery, and cost.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atrium Health; Carolinas Healthcare System
• Treatments: Antifibrinolytic Agents; Fibrinolytic Agents; Tranexamic Acid

Criteria

Inclusion Criteria:

• All patients aged 18 or above undergoing acetabular ORIF.

Exclusion Criteria:

• All patients aged below 18 years undergoing acetabulum surgery

• Patients with color-blindness (color vision changes used to assess toxicity)

• Patients with subarachnoid hemorrhage.

• Patients with active intravascular coagulation.

• Patients with a previous history of venous thromboembolism or with a history of hypercoaguable conditions (i.e. Factor V Leiden, antiphospholipid antibody).

• Prisoners

• Pregnant women