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NCT Number: NCT07686705

Intravenous Versus Intra-articular Tranexamic Acid for Visual Clarity During Arthroscopic Rotator Cuff Repair

This single-center, prospective, randomized, double-blind controlled trial evaluated whether intravenous (IV) or intra-articular (IA) administration of tranexamic acid (TXA) improves intraoperative visual clarity, compared with a no-TXA control, during arthroscopic rotator cuff repair. Patients with full-thickness rotator cuff tears were randomly allocated to one of three groups: a control group receiving no TXA; an IA group in which 500 mg of TXA was added to each 1 L of normal-saline irrigation fluid; and an IV group receiving 1000 mg of TXA intravenously 10 minutes before surgery. The operating surgeon graded visual clarity on a 0-10 numeric scale at the end of each of six predefined surgical stages. Secondary outcomes included total operative time, estimated blood loss, irrigation-fluid volume, the number of irrigation-pressure increases, postoperative shoulder swelling, and postoperative day 1 pain.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konkuk University Medical Center

Seoul, 05030, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80 years
  • Diagnosed with a rotator cuff tear
  • Failure of conservative treatment for more than 3 months
  • Rotator cuff deemed repairable on magnetic resonance imaging

Exclusion criteria

  • Known hypersensitivity to tranexamic acid
  • Previous cerebrovascular accident
  • Coronary stent or other history of thromboembolic disease
  • Anticoagulant therapy
  • Uncontrolled hypertension (systolic pressure > 180 mmHg)
  • Abnormal prothrombin time or activated partial thromboplastin time
  • Acute traumatic rotator cuff tear
  • Irreparable rotator cuff tear

Treatment and study plan

Tranexamic acid (intra-articular)

Drug

500 mg of tranexamic acid added per 1 L of normal-saline irrigation fluid.

Tranexamic acid (intravenous)

Drug

1000 mg of tranexamic acid administered intravenously 10 minutes before surgery.

Primary outcomes

  1. Intraoperative visual clarity

    Time frame: Intraoperatively, at the end of each of the six surgical stages

    Surgeon-rated clarity of the arthroscopic surgical field on a 0-10 numeric scale (0 = poorest visualization, 10 = optimal visualization), scored at the end of each of six surgical stages: glenohumeral procedure, subacromial bursectomy, acromioplasty, rotator cuff inspection, medial-row repair, and lateral-row repair.

Secondary outcomes

  1. Total operative time

    Time frame: Intraoperative (duration of surgery)

    Total duration of the surgical procedure.

  2. Estimated blood loss

    Time frame: From immediately before surgery to immediately after the end of surgery

    Estimated blood loss calculated from serum hemoglobin measured before and after surgery using the formula described by Good et al.

  3. Irrigation-fluid volume

    Time frame: Intraoperatively, from skin incision to skin closure (duration of surgery)

    Total volume of irrigation fluid used during the procedure.

  4. Number of irrigation-pressure increases

    Time frame: Intraoperatively, from skin incision to skin closure (duration of surgery)

    Number of times the irrigation pump pressure was increased to control bleeding affecting the surgical field

  5. Postoperative shoulder swelling

    Time frame: Baseline (pre-operative) and postoperative day 1

    Shoulder circumference and diameter measured at the axillary and deltoid sites with the arm abducted ~30 degrees, compared between pre-operative and postoperative day 1

  6. Postoperative pain

    Time frame: Pain assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse outcome, on postoperative day 1

    Pain assessed using a visual analog scale (VAS) on postoperative day 1

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

The Effect of Intravenous Versus Intra-articular Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Prospective, Randomized, Double-blind Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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