A Study Aiming to Demonstrate That the Addition of Intravenous (IV) Tranexamic Acid-Compared to P… (NCT07753161) | Clinical Trial Compass
CompletedNot Applicable
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.
France100 participantsStarted 2022-02-03
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hemoglobin loss
Timeframe: Day 0 (before intervention) and day 2 (post surgery)
Trial details
NCT IDNCT07753161
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche