Efficacy of Tranexamic Acid for Reducing Blood Loss and Blood Transfusion After Periacetabular Os… (NCT02253810) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Tranexamic Acid for Reducing Blood Loss and Blood Transfusion After Periacetabular Osteotomy
United States89 participantsStarted 2014-10
Plain-language 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.
Who can participate
Age range
12 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.