l’adjonction d’acide tranexamique IV versus placebo dans les ligamentoplasties du LCA entraine une diminution de la perte sanguine et des douleurs postopératoires

Multicentric, double-blind, randomized study to show that the addition of IV tranexamic acid versus placebo in ACL ligamentoplasties leads to a decrease in blood loss and postoperative pain - EXACYLCA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000039-33-FR

Enrollment

100

Registered

2020-04-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

Patients undergoing primary ACL ligamentoplasty with hamstring tendon removal on an outpatient basis

Interventions

Trade Name: EXACYL 0,5 g/5 ml Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patient, male or female, over 18 - Patient with an indication for primary ACL ligamentoplasty isolated +/- requiring an anterolateral plasty or meniscectomy / meniscal suture -Planned surgical procedure on an outpatient basis 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: -Patient with a history of ACL surgery -Patient with a history of knee surgery other than meniscectomy -Patient with pluriligamentary lesions of the knee -Patient with a contraindication to the use of tranexamic acid: history of pulmonary embolism or deep vein thrombosis, stroke or TIA, myocardial infarction or coronary stent, subarachnoid hematoma -Patient with pathology of hemostasis or treatment with AVK or anticoagulants or taking hormone replacement therapy -Patient with hepatic impairment -Patient with renal insufficiency -

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of IV tranexamic acid on the loss of hemoglobin on D2 in patients undergoing primary ACL ligamentoplasty with hamstring tendon sampling performed on an outpatient basis. ;Secondary Objective: -Evaluate the effect of IV tranexamic acid on the loss of hemoglobin on D5 and M1 in patients undergoing primary ACL ligamentoplasty with hamstring tendon removal on an outpatient basis. - Evaluate the effect of IV tranexamic acid on the formation of a hematoma on D0, D5 and D12 in patients undergoing primary ACL ligamentoplasty with hamstring tendon sampling performed on an outpatient basis. -Evaluate the effect of IV tranexamic acid on pain on Day 0 (H1 and H6 post induction), from Day 1 to Day 12 and to Month 1 -Evaluate the effect of IV tranexamic acid on the consumption of analgesics in the first 12 days following a primary ACL ligamentoplasty with removal of hamstring tendons performed on an outpatient basis. -Evaluate the effect of IV tranexamic acid on post-operative mobility at 1 month and 5 months in patients undergoing primary ACL ligamentoplasty with hamstring tendon sampling performed on an outpatient basis. ;Primary end point(s): The loss of hemoglobin between D0 (pre-operative, before any intervention) and Day 2 (post-operative), in absolute difference.;Timepoint(s) of evaluation of this end point: The main analysis of the primary endpoint is performed on the Intent to Treat Population. Very little missing data is expected. If however this should happen, the higher value imputation will be carried out, using a "missing = failure" approach.	—

Measure

Time frame

Main Objective: To evaluate the effect of IV tranexamic acid on the loss of hemoglobin on D2 in patients undergoing primary ACL ligamentoplasty with hamstring tendon sampling performed on an outpatient basis. ;Secondary Objective: -Evaluate the effect of IV tranexamic acid on the loss of hemoglobin on D5 and M1 in patients undergoing primary ACL ligamentoplasty with hamstring tendon removal on an outpatient basis. - Evaluate the effect of IV tranexamic acid on the formation of a hematoma on D0, D5 and D12 in patients undergoing primary ACL ligamentoplasty with hamstring tendon sampling performed on an outpatient basis. -Evaluate the effect of IV tranexamic acid on pain on Day 0 (H1 and H6 post induction), from Day 1 to Day 12 and to Month 1 -Evaluate the effect of IV tranexamic acid on the consumption of analgesics in the first 12 days following a primary ACL ligamentoplasty with removal of hamstring tendons performed on an outpatient basis. -Evaluate the effect of IV tranexamic acid on post-operative mobility at 1 month and 5 months in patients undergoing primary ACL ligamentoplasty with hamstring tendon sampling performed on an outpatient basis. ;Primary end point(s): The loss of hemoglobin between D0 (pre-operative, before any intervention) and Day 2 (post-operative), in absolute difference.;Timepoint(s) of evaluation of this end point: The main analysis of the primary endpoint is performed on the Intent to Treat Population. Very little missing data is expected. If however this should happen, the higher value imputation will be carried out, using a "missing = failure" approach.

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Secondary

Measure	Time frame
Secondary end point(s): -the loss of hemoglobin on D5 and M1 will be evaluated by the difference in the dosage of hemoglobin at this time compared to Day 0 -The formation of a hematoma on Day 0, Day 5 and Day 12 evaluated by a photograph of the lower limb operated on the anterior and posterior side at each time. The photographs will be reviewed by an independent speaker. -The consumption of analgesics will be assessed by the collection of analgesics using a patient diary -Post-operative mobility at 1 month and 5 months assessed using a goniometer by a single, independent practitioner. -The muscle recovery of the hamstrings and quadriceps at 5 months will be evaluated by an isokinetic test comparing the force of the operated leg against the force of the controlateral leg -Patient satisfaction at 5 months will be assessed using a satisfaction questionnaire ;Timepoint(s) of evaluation of this end point: Few missing data is expected on the main criterion. We assume a normal distribution of the main judgment criteria	—

Measure

Time frame

Secondary end point(s): -the loss of hemoglobin on D5 and M1 will be evaluated by the difference in the dosage of hemoglobin at this time compared to Day 0 -The formation of a hematoma on Day 0, Day 5 and Day 12 evaluated by a photograph of the lower limb operated on the anterior and posterior side at each time. The photographs will be reviewed by an independent speaker. -The consumption of analgesics will be assessed by the collection of analgesics using a patient diary -Post-operative mobility at 1 month and 5 months assessed using a goniometer by a single, independent practitioner. -The muscle recovery of the hamstrings and quadriceps at 5 months will be evaluated by an isokinetic test comparing the force of the operated leg against the force of the controlateral leg -Patient satisfaction at 5 months will be assessed using a satisfaction questionnaire ;Timepoint(s) of evaluation of this end point: Few missing data is expected on the main criterion. We assume a normal distribution of the main judgment criteria

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Countries

France

Contacts

Public ContactBARBA

ECTEN

mh.barba@ecten.eu

Outcome results

None listed

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