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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Enrolling; Phase 2

Conditions: Arthropathy of Hip

Treatments: Drug: Group 1: perfusion of 300 mg Exacyl; Drug: Placebo; Drug: Group 4: perfusion of 3000 mg Exacyl; Drug: Group 2: perfusion of 500 mg Exacyl; Drug: Group 3: perfusion of 1000 mg Exacyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03822793

18CH052

2018-004552-37 (EudraCT Number)

2022-502532-38-01 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Group 1: perfusion of 300 mg Exacyl

Experimental group

Description:

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.

Treatment:

Drug: Group 1: perfusion of 300 mg Exacyl

Group 2: perfusion of 500 mg Exacyl

Experimental group

Description:

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..

Treatment:

Drug: Group 2: perfusion of 500 mg Exacyl

Group 3: perfusion of 1000 mg Exacyl

Experimental group

Description:

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.

Treatment:

Drug: Group 3: perfusion of 1000 mg Exacyl

Group 4: perfusion of 3000 mg Exacyl

Experimental group

Description:

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.

Treatment:

Drug: Group 4: perfusion of 3000 mg Exacyl