A Dose-response Study of Tranexamic Acid in Total Hip Arthroplasty

Arthropathy of Hip Clinical Trial

— PRADO  

Official title:

Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Post-operative Hemoglobin Loss: A Phase 2 Randomized Double-blind Monocentric Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03822793
• Other study ID #: 18CH052
• Secondary ID: 2018-004552-3720
• Status: Recruiting
• Phase: Phase 2
• Start date: December 7, 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Julien LANOISELEE, MD
• Phone: (0)477828554
• Email: julien.lanoiselee[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Hip
• Joint Diseases

Intervention

Drug:
• Placebo
Patient will receive an intravenous perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 9 minutes, starting at the time of surgical incision.
• Group 1: perfusion of 300 mg Exacyl
Patient will receive an intravenous perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.
• Group 2: perfusion of 500 mg Exacyl
Patient will receive an intravenous perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.
• Group 3: perfusion of 1000 mg Exacyl
Patient will receive an intravenous perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.
• Group 4: perfusion of 3000 mg Exacyl
Patient will receive an intravenous perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	haemoglobin decrease in the perioperative period	Percentage of haemoglobin change in the perioperative period. It requires the sampling of haemoglobin just before surgery (Day 1) and on the eighth postoperative day	Day 1 to Day 8
Secondary	Tranexamic acid pharmacokinetics	For tranexamic acid pharmacokinetics, the outcome measure is the sampling of tranexamic blood concentration.	Day 1
Secondary	D-Dimer kinetics	For tranexamic acid pharmacodynamics, the outcome is the sampling of D-Dimer levels.	Day 1
Secondary	allogenic red blood cell transfusion	For allogenic red blood cell transfusion, the outcome measure will be the percentage of patients that will receive the transfusion of at least one allogenic red blood cell unit in the perioperative period.	Day 1 to day 8
Secondary	severe anaemia	For severe anaemia (defined as a level of haemoglobin <10 gram by deciliter), the outcome measure will be the percentage of patients that will have at least one value of haemoglobin <10 gram by deciliter in the perioperative period.	Day 1 to day 8
Secondary	incidence of symptomatic thrombotic events and death	For the incidence of symptomatic thrombotic events and death, the outcome measure is a combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death.	Day 1 to day 8
Secondary	occurrence of a seizure	The endpoint is a combined criteria endpoint involving either the clinical observation of a generalized tonic-clonic seizure or a partial seizure or an epilepsy confirmed by an electroencephalogram interpreted by a neurologist blinded to the patient's inclusion group.	Day 8