The Aim of This Study is to Examine the Effect of Intravenously Administered Tranexamic Acid (TXA) on the Visual Clarity, Perioperative Hemorrhage, Duration and Early Postoperative Course of Shoulder Arthroscopy in Beach Chair Position.

• Status: Enrolling by invitation
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Shoulder arthroscopy provides many benefits with a permanent increase in the possibilities and complexity of the application. A condition to perform it is intraoperative visual clarity dependent on hemorrhage control. The aim of this prospective, double blind, randomized, and controlled study is to examine the effect of intravenously administered tranexamic acid (TXA) on the visual clarity, perioperative hemorrhage, duration and early postoperative course of shoulder arthroscopy in beach chair position, which is not yet available in the literature. In the tested and control group, the investigators measure hemoglobin (Hb) in the waste irrigation fluid and the patient's blood before and after the procedure, visual clarity, duration of the procedure, postoperative shoulder swelling, pain level and analgesic drug consumption. The research uses scientific methods to determine if there is a reasonable basis for introducing TXA into routine clinical use.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nikola Matejcic
• Collaborators: University of Rijeka, The Faculty of Medicine; University of Zagreb, The Faculty of Kinesiology; University orthopaedic and trauma hospital Lovran
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• rotator cuff tear

• instability of the glenohumeral joint

• instability of the acromioclavicular joint

Exclusion Criteria:

• allergy to tranexamic acid

• deep vein thrombosis

• congenital thrombophilia

• coagulopathy

• thromboembolic events last 12 months

• stroke or acute coronary syndrome last 3 months

• renal failure

• cirrhosis of the liver

• glaucoma or retinal vascular disorder

• chronic treatment with anticoagulant therapy

• uncontrolled hypertension