Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Post-operative Hemoglobin Loss: A Phase 2 Randomized Double-blind Monocentric Study
Overview
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- haemoglobin decrease in the perioperative period
Overview
Brief 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.
Detailed Description
This dose-response study is a randomized double blind study with five groups of 30 patients each. Patients will be randomized to placebo, tranexamic acid (TXA) 300 mg, tranexamic acid (TXA) 500 mg, tranexamic acid (TXA) 1000 mg or tranexamic acid (TXA) 3000 mg. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of tranexamic acid (TXA) plasma concentration as a predictor of intra and postoperative D-Dimer values.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
randomized double blind study
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
haemoglobin decrease in the perioperative period
Time Frame: Day 1 to Day 4
Percentage of haemoglobin change in the perioperative period. It requires the sampling of haemoglobin just before surgery (Day 1) and on the fourth postoperative day
Secondary Outcomes
- occurrence of a seizure(Day 8)
- allogenic red blood cell transfusion(Day 1 to day 8)
- severe anaemia(Day 1 to day 8)
- incidence of symptomatic thrombotic events and death(Day 1 to day 8)
- Tranexamic acid pharmacokinetics(Day 1)
- D-Dimer kinetics(Day 1)
- number of adverse events(Day: 45)