LigamentoplastyEXACYLCANCT07753161
A Study Aiming to Demonstrate That the Addition of Intravenous (IV) Tranexamic Acid-Compared to Placebo-During Anterior Cruciate Ligament (ACL) Reconstruction Results in Reduced Blood Loss and Postoperative Pain.
A study testing ACL reconstruction in people with Ligamentoplasty and Anterior Cruciate Ligament (ACL), run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Various reconstruction and graft harvesting techniques are used for ACL reconstruction. The most common techniques involve harvesting one or more hamstring tendons. These tendons are harvested using minimally invasive approaches with "strippers," which do not allow for hemostasis at the base of the thigh-specifically… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ligamentoplasty, Anterior Cruciate Ligament (ACL)
- What is being tested?
- ACL reconstruction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient aged over 18 years4
- Patient with a surgical indication for primary reconstruction of an isolated ACL, +/- requiring an anterolateral reconstruction procedure or meniscectomy/meniscal repair
- Planned outpatient surgical procedure
- Patient affiliated with or a beneficiary of a social security scheme
- Patient informed about the study and having signed the informed consent form
Who cannot join
- Patient with a history of ACL surgery
- Patient with a history of knee surgery other than meniscectomy
- Patient with multi-ligament knee injuries (PCL, MCL, or LCL)
- Patient with a contraindication to the use of tranexamic acid: Hypersensitivity to the active substance or any of the excipients, acute venous or arterial thrombosis, fibrinolytic states resulting from consumptive coagulopathy (except in states associated with predominant activation of the fibrinolytic system with acute severe hemorrhage), severe renal impairment (risk of accumulation), history of convulsions, intrathecal and intraventricular injections, intracerebral applications (risk of cerebral edema and convulsions)
- Patient with a hemostatic disorder, undergoing treatment with VKAs or anticoagulants, or receiving hormone replacement therapy
- Patient with hepatic impairment
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- Patient with renal impairment
- Patient unable or not in a position to agree to the entire procedure and follow-up required by the study
- Patient participating in another clinical study
- Protected patient: adult under guardianship, curatorship, or other legal protection; deprived of liberty by judicial or administrative decision
- Pregnant or breastfeeding woman
- Patient hospitalized without consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Multicenter Study Aiming to Demonstrate That the Addition of Intravenous (IV) Tranexamic Acid-Compared to Placebo-During Anterior Cruciate Ligament (ACL) Reconstruction Results in Reduced Blood Loss and Postoperative Pain.
Various reconstruction and graft harvesting techniques are used for ACL reconstruction. The most common techniques involve harvesting one or more hamstring tendons. These tendons are harvested using minimally invasive approaches with "strippers," which do not allow for hemostasis at the base of the thigh-specifically at the myotendinous junction where the proximal end of the graft is severed. This lack of hemostasis consistently leads to varying degrees of bleeding in the hours or even days following surgery. This bleeding causes pain, hematomas, and muscle inhibition (particularly of the hamstrings), thereby hindering the resumption of activities and delaying physical therapy progress. Tranexamic acid is an antifibrinolytic agent currently gaining widespread use in orthopedic surgery to prevent intraoperative and postoperative bleeding, particularly in knee and hip arthroplasty. Numerous recent publications, including meta-analyses, have demonstrated its efficacy and safety. Only one study has investigated the effect of tranexamic acid in the context of ACL reconstruction, showing a reduction in postoperative pain. The main objective is to evaluate the effect of intravenous tranexamic acid on hemoglobin loss at postoperative day 2 in patients undergoing primary ACL reconstruction with hamstring tendon harvesting on an outpatient basis.
- Conditions
- Ligamentoplasty, Anterior Cruciate Ligament (ACL)
- Being tested
- ACL reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstructionProcedure or surgery
The surgical procedure is performed under regional or general anesthesia. The study treatment is tranexamic acid. It is administered as two 50 ml slow intravenous (IV) infusions (via infusion bags) containing 1 gram each, resulting in a total injected dose of 2 grams. The first infusion is administered at H0-1h (before induction) and the second at H0+3h.
The comparator treatment is a placebo (saline solution). It is administered as two 50 ml slow intravenous (IV) infusions (via infusion bags). The first infusion is administered at H0-1h (before induction) and the second at H0+3h.
| Study group | Role | What they receive |
|---|---|---|
| Patient treated with Tranexamin acid | Experimental | Not described Receives: Procedure: ACL reconstruction |
| Patient treated with placebo | Placebo comparator | Not described Receives: Procedure: ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin loss
Hemoglobin loss between Day 0 (pre-operative, before any intervention) and Day 2 (post-operative), expressed as an absolute difference.
Measured: Day 0 (before intervention) and day 2 (post surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start3 Feb 2022
- Primary completion4 Nov 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LigamentoplastyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753161
- Sponsor's protocol ID
- 2020-000039-33
- Acronym
- EXACYLCA
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Study Aiming to Demonstrate That the Addition of Intravenous (IV) Tranexamic Acid-Compared to Placebo-During Anterior Cruciate Ligament (ACL) Reconstruction Results in Reduced Blood Loss and Postoperative Pain.
- ClinicalTrials.gov ID
- NCT07753161
- Acronym / sponsor ID
- EXACYLCA / 2020-000039-33
- Conditions
- Ligamentoplasty, Anterior Cruciate Ligament (ACL)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Various reconstruction and graft harvesting techniques are used for ACL reconstruction. The most common techniques involve harvesting one or more hamstring tendons. These tendons are harvested using minimally invasive approaches with "strippers," which do not allow for hemostasis at the base of the thigh-specifically at the myotendinous junction where the proximal end of the graft is severed. This lack of hemostasis consistently leads to varying degrees of bleeding in the hours or even days following surgery. This bleeding causes pain, hematomas, and muscle inhibition (particularly of the hamstrings), thereby hindering the resumption of activities and delaying physical therapy progress. Tranexamic acid is an antifibrinolytic agent currently gaining widespread use in orthopedic surgery to prevent intraoperative and postoperative bleeding, particularly in knee and hip arthroplasty. Numerous recent publications, including meta-analyses, have demonstrated its efficacy and safety. Only one study has investigated the effect of tranexamic acid in the context of ACL reconstruction, showing a reduction in postoperative pain. The main objective is to evaluate the effect of intravenous tranexamic acid on hemoglobin loss at postoperative day 2 in patients undergoing primary ACL reconstruction with hamstring tendon harvesting on an outpatient basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient treated with Tranexamin acid | Experimental | Procedure: ACL reconstruction |
| Patient treated with placebo | Placebo comparator | Procedure: ACL reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patient aged over 18 years4
- Patient with a surgical indication for primary reconstruction of an isolated ACL, +/- requiring an anterolateral reconstruction procedure or meniscectomy/meniscal repair
- Planned outpatient surgical procedure
- Patient affiliated with or a beneficiary of a social security scheme
- Patient informed about the study and having signed the informed consent form
Key exclusion criteria (12 listed)
- Patient with a history of ACL surgery
- Patient with a history of knee surgery other than meniscectomy
- Patient with multi-ligament knee injuries (PCL, MCL, or LCL)
- Patient with a contraindication to the use of tranexamic acid: Hypersensitivity to the active substance or any of the excipients, acute venous or arterial thrombosis, fibrinolytic states resulting from consumptive coagulopathy (except in states associated with predominant activation of the fibrinolytic system with acute severe hemorrhage), severe renal impairment (risk of accumulation), history of convulsions, intrathecal and intraventricular injections, intracerebral applications (risk of cerebral edema and convulsions)
- Patient with a hemostatic disorder, undergoing treatment with VKAs or anticoagulants, or receiving hormone replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL reconstructionThe surgical procedure is performed under regional or general anesthesia. The study treatment is tranexamic acid. It is administered as two 50 ml slow intravenous (IV) infusions (via infusion bags) containing 1 gram each, resulting in a total injected dose of 2 grams. The first infusion is administered at H0-1h (before induction) and the second at H0+3h. The comparator treatment is a placebo (saline solution). It is administered as two 50 ml slow intravenous (IV) infusions (via infusion bags). The first infusion is administered at H0-1h (before induction) and the second at H0+3h. | Procedure or surgery | Patient treated with Tranexamin acid, Patient treated with placebo |
Primary outcome
Hemoglobin loss
Time frame: Day 0 (before intervention) and day 2 (post surgery)
Hemoglobin loss between Day 0 (pre-operative, before any intervention) and Day 2 (post-operative), expressed as an absolute difference.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction in people with Ligamentoplasty and Anterior Cruciate Ligament (ACL), run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin loss (time frame: Day 0 (before intervention) and day 2 (post surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.