Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid

National Cheng-Kung University

Status: Completed

Conditions: Surgical Blood Loss; Tranexamic Acid; Shoulder Arthorscopy Surgery; Rotator Cuff Tears

Treatments: Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml; Drug: 0.9% Sodium Chloride Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04025736

A-BR-106-017

Details and patient eligibility

About

Purpose: The study aimed to determine whether intravenous administration of tanexamic acid (TXA) before shoulder arthroscopic rotator cuff repair surgery can improve arthroscopy visual clarity. Methods: This is a prospective, double-blinded, randomized and placebo-controlled study. From May 2016 to April 2018, patients requiring arthroscopic rotator cuff repair were enrolled and randomly assigned to either the TXA group that received 1000mg tranexamic acid intravenously 10 minutes before surgery or the placebo group that received the same volume of plain saline. Patients with pre-existing liver/renal disease, coagulopathy, or concurrent use of anti-coagulation medications were excluded. The visual clarity was rated by a numeric rating scale from grade

1(poor) to grade 3(clear) every 15 minutes throughout the surgery. Secondary outcomes included estimated perioperative blood loss, operative time, degree of shoulder swelling, postoperative subjective pain score, inpatient duration and associated comorbidities were recorded. Both parametric and nonparametric methods were used for statistical analysis.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who were diagnosed with rotator cuff tear and failure of conservative treatment for more than 3 months. The tear size was measured by MRI and must be repairable.

Exclusion criteria

• Acute traumatic rotator cuff tear.
• History of coagulopathy
• Under anticoagulation therapy before surgery
• Abnormal coagulation profile (prothrombin time or activated partial thromboplastin time) before surgery
• Renal or liver disorder
• Uncontrolled hypertension (baseline systolic pressure >180 mmHg)
• Allergy to local anesthetic agent or TXA.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Patients received Tranexamic acid

Experimental group

Description:

The patient was assigned as intervention group, TXA will be aspirated into a syringe. In TXA group, TXA 1000 mg (20 mL) was given intravenously 10 minutes before surgery.

Treatment:

Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml

Patients received same volume of saline

Placebo Comparator group

Description:

In the control group, the patient received 20ml saline intravenous also 10 min before surgery.

Treatment:

Drug: 0.9% Sodium Chloride Injection