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

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Age greater than or equal to 12 years old

• Age less than or equal to 45 years old

• Indicated for elective periacetabular osteotomy

Exclusion Criteria:

• Preoperative use of an anticoagulant (Plavix, warfarin, lovenox, etc.)

• History of hypersensitivity to tranexamic acid

• History of thromboembolic event (e.g., Pulmonary embolism or Deep vein thrombosis)

• History of subarachnoid hemorrhage

• History or evidence of hepatic dysfunction (aspartate transaminase-alanine transaminase ratio greater than 60) or renal dysfunction (Creatinine greater than 1.5 mg/dL, or glomerular filtration rate less than 30 mL/minute)

• History of seizure

• Coronary stents or prior diagnosis of coronary artery disease

• Color blindness

• Leukemia

• Congenital or acquired coagulopathy as evidence by international normalized ratio (INR) greater than 1.4 or partial thromboplastin time (PTT) > 1.4 times normal, or Platelets less than 150,000/mm^3 on preoperative laboratory testing

• Use of hormone replacement therapy or hormonal contraceptive agent within 7 days prior to surgery

• Pregnant

• Breastfeeding

• Donated preoperative autologous blood

• Younger than 12-years-old and older than 45-years-old

• Preoperative hemoglobin less than 10 g/dL

• Concomitant open procedures (e.g., femoral osteotomy or osteochondral allograft)

• Patients with any contraindication to neuraxial anesthesia:

• Patient refusal

• History of lumbar spinal fusion

• Infection at the site of the epidural

• Coagulopathy, as defined above

• Ventriculoperitoneal shunt