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

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

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Drug: Tranexamic acid (intra-articular); Drug: Tranexamic acid (intravenous)

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 05030
      • Konkuk University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No tranexamic acid; arthroscopic rotator cuff repair performed with plain normal-saline irrigation.
Experimental: Intra-articular TXA; Tranexamic acid 500 mg added to each 1 L of normal-saline irrigation fluid during arthroscopic rotator cuff repair.	Drug: Tranexamic acid (intra-articular); 500 mg of tranexamic acid added per 1 L of normal-saline irrigation fluid.
Experimental: Intravenous TXA; Tranexamic acid 1000 mg administered intravenously 10 minutes before surgery; plain normal-saline irrigation as in the control group.	Drug: Tranexamic acid (intravenous); 1000 mg of tranexamic acid administered intravenously 10 minutes before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative visual clarity	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.	Intraoperatively, at the end of each of the six surgical stages

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total operative time	Total duration of the surgical procedure.	Intraoperative (duration of surgery)
Estimated blood loss	Estimated blood loss calculated from serum hemoglobin measured before and after surgery using the formula described by Good et al.	From immediately before surgery to immediately after the end of surgery
Irrigation-fluid volume	Total volume of irrigation fluid used during the procedure.	Intraoperatively, from skin incision to skin closure (duration of surgery)
Number of irrigation-pressure increases	Number of times the irrigation pump pressure was increased to control bleeding affecting the surgical field	Intraoperatively, from skin incision to skin closure (duration of surgery)
Postoperative shoulder swelling	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	Baseline (pre-operative) and postoperative day 1
Postoperative pain	Pain assessed using a visual analog scale (VAS) on postoperative day 1	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

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Investigators: Principal Investigator: Seok Won Chung, MD, Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): August 25, 2023
• Study Completion (Actual): August 26, 2023

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: tranexamic acid; shoulder arthroscopy; rotator cuff repair; visual clarity; intra-articular administration
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: 2022-12-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No