The Effect of Tranexamic Acid Vs Torniquet on Visual Clarity in Knee Arthroscopic ACL Reconstruction (NCT06781021) | Clinical Trial Compass
By InvitationNot Applicable
The Effect of Tranexamic Acid Vs Torniquet on Visual Clarity in Knee Arthroscopic ACL Reconstruction
Jamaica60 participantsStarted 2024-11-01
Plain-language summary
Study Objective: The study aims to determine if tranexamic acid (TXA) is as effective as a tourniquet in improving visual clarity during arthroscopic ACL reconstruction surgery.
Study Design: This is a randomized prospective controlled trial involving patients with complete ACL tears. Participants will be randomly assigned to either receive TXA or undergo surgery with a tourniquet.
Data Collection: The study will use questionnaires and scales to assess the effects of TXA on visual clarity. Data will be stored securely and analyzed using the SPSS system.
Ethical Considerations: Ethical guidelines will be strictly followed, including informed consent, confidentiality, and the right to withdraw from the study at any time without affecting the standard of care.
Expected Outcome: The study aims to provide insights into the efficacy of TXA in improving surgical visibility, potentially influencing future protocols in arthroscopic surgeries. Results will be disseminated through academic presentations and publications.
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:
* All patients with complete ACL tears requiring reconstruction for the first time.
* Ages \>18
Exclusion Criteria:
* Dementia or any patient with cognitive impairment.
* Patients with previous functional disabilities (Patients with functional disabilities affecting the lower limb such as stroke, neuromuscular disorders or any pathology limiting Knee range of motion can cause abnormalities within the joint enabling scaring, fibrosis or even hypoplastic degenerating tissue. These features may alter the vascularity and directly affect visual clarity)
* Bleed disorders or coagulopathies.
* Sickle Cell Disease, liver, or renal failure.
* Multi- ligamentous knee injuries.
* Anticoagulant therapy.
* Revision ACL reconstruction.
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
Grading TXA
Timeframe: The questionnaire will be administered to the surgeon right after surgery is completed.
2
Grading Tourniquet
Timeframe: The questionnaire will be administered to the surgeon right after surgery is completed.
3
Grading Tourniquet vs TXA
Timeframe: The questionnaire will be administered to the surgeon right after surgery is completed.