Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Post-operative Hemoglobin Loss: A Phase 2 Randomized Double-blind Monocentric Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A single preoperative dose of tranexamic acid (TXA) reduces blood loss and red blood cell transfusion in primary hip arthroplasty. Numerous regimens have been tested, ranging from 10mg/kg up to 3g. However the optimal dose to administer is unknown.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
CHU Saint-Etienne
RECRUITING
Saint-etienne
Contact Information
Primary
Julien LANOISELEE, MD
julien.lanoiselee@chu-st-etienne.fr
(0)477828554
Backup
Béatrice DEYGAS, CRA
beatrice.deygas@chu-st-etienne.fr
(0)477127655
Time Frame
Start Date: 2023-12-07
Estimated Completion Date: 2026-12
Participants
Target number of participants: 170
Treatments
Placebo_comparator: Placebo
Patient will be included in this group by randomization and they will receive an intravenous perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 9 minutes, starting at the time of surgical incision.
Experimental: Group 1: perfusion of 300 mg Exacyl
Patient will be included in the group 2 by randomization and they will receive an intravenous perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.
Experimental: Group 2: perfusion of 500 mg Exacyl
Patient will be included in the group 2 by randomization and they will receive an intravenous perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision..
Experimental: Group 3: perfusion of 1000 mg Exacyl
Patient will be included in the group 3 by randomization and they will receive an intravenous perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.
Experimental: Group 4: perfusion of 3000 mg Exacyl
Patient will be included in the group 4 by randomization and they will receive an intravenous perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.
Authors
Zeina PRADES, Paul ZUFFEREY
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Saint Etienne