Status:
COMPLETED
Efficacy of Tranexamic Acid for Reducing Blood Loss and Blood Transfusion After Periacetabular Osteotomy
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Dysplasia, Congenital Hip
Eligibility:
All Genders
12-45 years
Phase:
NA
Brief 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 periacetabu...
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...
Eligibility Criteria
Inclusion
- Age greater than or equal to 12 years old
- Age less than or equal to 45 years old
- Indicated for elective periacetabular osteotomy
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT02253810
Start Date
October 1 2014
End Date
October 1 2018
Last Update
November 25 2022
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021