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

Study of the noninferiority of an oral versus intravenous administration of tranexamic acid in total hip arthroplasty

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004167-29-BE

Enrollment

258

Registered

2021-02-08

Start date

2021-03-15

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding in total hip arthroplasty

Interventions

Trade Name: Exacyl oral Pharmaceutical Form: Tablet INN or Proposed INN: tranexamic acid Other descriptive name: TRANEXAMIC ACID Concentration unit: mg milligram(s) Concentration type: range Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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	—

Measure

Time frame

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. 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

Measure	Time frame
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. 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...);Timepoint(s) of evaluation of this end point: 48 hours after surgery	—

Measure

Time frame

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. 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...);Timepoint(s) of evaluation of this end point: 48 hours after surgery

—

Countries

Belgium

Contacts

Public ContactPiette Nicolas

CHU de Liège

mcarella@chuliege.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026