Phase 4
N=84
Effect of Intravenous Tranexamic Acid on Visual Clarity During Shoulder Arthroscopy in the Beach Chair Position
Rotator Cuff Tears · Hemorrhage, Surgical · Shoulder Injuries
Bottom Line
View on ClinicalTrials.gov: NCT05397652 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Visual Clarity on Endoscope Screen During Shoulder Arthroscopy (Intraoperative) — 7.79; 7.24 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic Acid Injectable Product (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nikola Matejcic
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Clarity on Endoscope Screen During Shoulder Arthroscopy (Intraoperative) |
7.79; 7.24 | — |
| SECONDARY Independent Assessor Visibility Rating (VAS) |
6.41; 6.13 | — |
| SECONDARY Interobserver Agreement of Independent Assessors for Arthroscopic Visibility Ratings (VAS) |
0.89; 0.89 | — |
| SECONDARY Comparison of Arthroscopic Visibility Ratings Between the Operating Surgeon and Independent Assessors (VAS) |
7.10; 6.68 | — |
| SECONDARY Concentration of Hemoglobin in Waste Irrigation Fluid (mg/100 mL) |
19.30; 20.27 | — |
| SECONDARY Number of Irrigation Pump Pressure-boost Events |
23.40; 18.83 | — |
| SECONDARY Total Irrigation Fluid Volume Used (L) |
34.71; 28.94 | — |
| SECONDARY Intraoperative Mean Arterial Pressure (MAP), mmHg |
79.32; 79.11 | — |
| SECONDARY Duration of Surgery (Minutes) |
127.81; 112.71 | — |
| SECONDARY Intraoperative Blood Loss (mL) |
40.79; 33.48 | — |
| SECONDARY Total Perioperative Blood Loss (mL) |
763.57; 768.44 | — |
| SECONDARY Postoperative (Hidden) Blood Loss (mL) |
722.78; 734.96 | — |
| SECONDARY Perioperative Drop in Hemoglobin (g/dL) |
1.97; 1.99 | — |
| SECONDARY Change in Upper-arm Circumference (cm) as Marker of Swelling |
3.29; 4.60 | — |
| SECONDARY Postoperative Pain (VAS, 0-10) |
3.65; 3.72 | — |
| SECONDARY Total Postoperative Analgesic Consumption (mg) |
3445.35; 3014.63 | — |
| SECONDARY Length of Hospital Stay (Days) |
2.07; 2.22 | — |
Summary
Shoulder arthroscopy offers numerous advantages and has led to a continuous increase in procedural complexity. Adequate intraoperative visual clarity is essential for successful performance of the procedure and is primarily dependent on effective hemorrhage control.The aim of this prospective, double-blind, randomized controlled study is to evaluate the effect of intravenously administered tranexamic acid (TXA) on intraoperative visual clarity, perioperative blood loss, procedure duration, and early postoperative outcomes in patients undergoing shoulder arthroscopy in the beach chair position, an area for which limited data are currently available in the literature. In both the experimental and control groups, hemoglobin levels are measured in the irrigation fluid and in patients' blood samples obtained before and after surgery. Additional outcomes include intraoperative visual clarity, duration of the procedure, postoperative shoulder swelling, postoperative pain intensity, and analgesic consumption.This study applies established scientific methods to determine whether there is a justified basis for the introduction of TXA into routine clinical practice for shoulder arthroscopy.
Eligibility Criteria
Inclusion Criteria
- rotator cuff tear
Exclusion Criteria
- allergy to tranexamic acid, paracetamol (acetaminophen), ketoprofen, tramadol or metamizole sodium
- deep vein thrombosis
- congenital thrombophilia
- coagulopathy
- thromboembolic events within the previous 12 months
- stroke or acute coronary syndrome within the previous 3 months
- renal failure
- liver cirrhosis
- glaucoma or retinal vascular disorder
- chronic treatment with anticoagulant or antiplatelet therapy
- uncontrolled hypertension (systolic blood pressure > 180 mmHg)
Data sourced from ClinicalTrials.gov (NCT05397652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.