The Effect of Tranexamic Acid Vs Torniquet on Visual Clarity in Knee Arthroscopic ACL Reconstruction

NCT06781021 | Enrolling By Invitation DMC

• 1 other identifier: CREC-MN.049,2023/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ACL Tears

Keywords

ACL Tear

Outcome Measures

Primary Outcomes (3)

• Grading TXA

  The grading allotted to patients treated with tranexamic acid assed by the Arthroscopic visual clarity scale.

  The questionnaire will be administered to the surgeon right after surgery is completed.

• Grading Tourniquet

  The Grading given to patients treated with Pneumatic torniquet assessed by the Arthroscopic Visual clarity scale

  The questionnaire will be administered to the surgeon right after surgery is completed.

• Grading Tourniquet vs TXA

  The grading given to patients treated with TXA vs Pneumatic torniquet assessed by the arthroscopic visual clarity scale

  The questionnaire will be administered to the surgeon right after surgery is completed.

Study Arms (2)

Tourniquet Surgery

ACTIVE COMPARATOR

Torniquet surgery prevents blood loss by acting as a physical barrier to cut vessels and tissue. This physical barrier is in the form of pressure which is applied to the vessels but also to the surrounding tissues it touches. This pressure can damage nerves, muscle which can delay return to normal function afterwards if applied for a prolonged period. This however has not been a common occurrence and is used as the standard of care in ACL arthroscopic surgeries.

Procedure: Tourniquet; Procedure: TXA

TXA Surgery

ACTIVE COMPARATOR

TXA does the has the same function without the physical compression. In other words, it acts as a chemical torniquet. It enables clotting at damaged tissue which are more likely to bleed and obstruct the surgical field. This drug has not been shown to have any adverse reactions and is safe for use.

Procedure: Tourniquet; Procedure: TXA

Interventions

Tourniquet PROCEDURE

In all cases the application of a pneumatic torniquet will be applied to the proximal thigh after induction of anesthesia but will not be inflated for the group receiving TXA.

TXA Surgery; Tourniquet Surgery

TXA PROCEDURE

In all cases the application of a pneumatic torniquet will be applied to the proximal thigh after induction of anesthesia but will not be inflated for the group receiving TXA.

TXA Surgery; Tourniquet Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with complete ACL tears requiring reconstruction for the first time.
• Ages \>18

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

University Hospital of the West Indies, Department of Surgery

Kingston, Jamaica, Jamaica

Location

Related Publications (38)

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MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: All patients will be positioned supine and administered spinal anesthesia. In all cases the application of a pneumatic torniquet will be applied to the proximal thigh after induction of anesthesia but will not be inflated for the group receiving TXA. Dependent on the randomized groups assigned; The standard torniquet pressure of 300 mm Hg will only be inflated for persons assigned to the torniquet group who will receive normal saline intravenously. Only the research assistant and the anesthetic staff will be aware of whether inflation of torniquet was applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: January 17, 2025
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: January 17, 2025

Record last verified: 2024-10

Locations

JA (1)