Evaluation of equivalence between oral versus intravenous administration of tranexamic acid in total hip replacement surgery

Phase 1

• Conditions: Bleeding in total hip arthroplasty; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-004167-29-BE
• Lead Sponsor: CHU de Liège

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-08
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

- Adult patients >18 year old
- Physical status score ASA 1-2-3
- Scheduled for total hip arthroplasty, under regional anesthesia (supra-inguinal fascia-iliaca block) combined with general or spinal anesthesia.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 129
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 129

Exclusion Criteria

Kidney injury
Pregnant women
Patients who were diagnosed with thromboembolic disease in last 12 months
Patients having undergone a digestive surgery that could lead to malabsorption (sleeve, by-pass, gastrectomy, intragastric balloon)
Insulin-dependent diabetic with gastroparesis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The efficiency of oral tranexamic acid is noninferior to intraveinous administration;Secondary Objective: Evaluation and monitoring of the serum dosage of tranexamic acid at the incision as well as 4 hours post-administration in order to correlate blood loss and plasma concentration of the molecule. <br>Evaluation of the decreased hemoglobin level monitored in post-operative biological controls at Day 1 and Day 3, the prevalence of post-operative renal insufficiency, the duration of the hospital stay, the prevalence of common post-operative complications (venous thrombosis, embolism, early infection...);Primary end point(s): Primary end point will be the assessment of blood loss in the first 48 hours post- operation;Timepoint(s) of evaluation of this end point: 48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The monitoring of the serum dosage of tranexamic acid at the incision as well as 4 hours post-administration in order to correlate blood loss and plasma concentration of the molecule. <br>The decreased hemoglobin level monitored in post-operative biological controls at Day 1 and Day 3. <br>The prevalence of post-operative renal insufficiency. <br>The duration of the hospital stay. <br>The prevalence of common post-operative complications (venous thrombosis, embolism, early infection...);Timepoint(s) of evaluation of this end point: 48 hours after surgery