Testing different doses of tranexamic acid for hip surgery
Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Post-operative Hemoglobin Loss: A Phase 2 Randomized Double-blind Monocentric Study
PHASE2 · Centre Hospitalier Universitaire de Saint Etienne · NCT03822793
This study is testing different doses of tranexamic acid to see which one best reduces blood loss and the need for blood transfusions during hip replacement surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne (other) |
| Locations | 1 site (Saint-Étienne) |
| Trial ID | NCT03822793 on ClinicalTrials.gov |
What this trial studies
This study investigates the optimal dose of tranexamic acid (TXA) to minimize blood loss and the need for blood transfusions during primary hip arthroplasty. It is a randomized double-blind trial involving five groups of patients receiving varying doses of TXA or a placebo. The study also includes a pharmacokinetic/pharmacodynamic analysis to assess the relationship between TXA plasma levels and postoperative D-Dimer values. By determining the most effective dose, the study aims to enhance surgical outcomes for patients undergoing hip replacement surgery.
Who should consider this trial
Good fit: Ideal candidates are patients requiring primary hip arthroplasty and affiliated with the French Social Security Healthcare system.
Not a fit: Patients with hip fractures, contraindications to tranexamic acid, or those on chronic anticoagulants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced blood transfusion needs for patients undergoing hip arthroplasty.
How similar studies have performed: Previous studies have shown that tranexamic acid can effectively reduce blood loss in surgical settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient requiring primary hip arthroplasty (less than 3 months) * Informed Consent from the patient or their legally authorized representative * Affiliation to French Social Security Healthcare system Exclusion Criteria: * Hip fracture of less than 3 months * Bilateral hip arthroplasty or anterior approach to hip arthroplasty * Haemorrhagic surgery in the previous 2 weeks * Contraindication to tranexamic acid * Contraindication to apixaban * Chronic use of anticoagulant * Pregnancy * Previous participation to this study
Where this trial is running
Saint-Étienne
- CHU Saint-Etienne — Saint-Étienne, France (RECRUITING)
Study contacts
- Principal investigator: Julien LANOISELEE, MD — CHU SAINT-ETIENNE
- Study coordinator: Julien LANOISELEE, MD
- Email: julien.lanoiselee@chu-st-etienne.fr
- Phone: (0)477828554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arthropathy of Hip, tranexamic acid, arthroplasty, hip, Exacyl