Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid

Not Applicable

Completed

• Conditions: Surgical Blood Loss; Rotator Cuff Tears; Tranexamic Acid; Shoulder Arthorscopy Surgery
• Interventions: Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml; Drug: 0.9% Sodium Chloride Injection

• Registration Number: NCT04025736
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-07
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Status Verified: 2019-07
• Study First Submitted: 2019-07-14
• Study First Submitted QC: 2019-07-17
• Last Update Submitted: 2019-07-17
• Study First Posted: 2019-07-19
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients received Tranexamic acid	Tranexamic Acid 100Mg/Ml Inj Vil 10Ml	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.
Patients received same volume of saline	0.9% Sodium Chloride Injection	In the control group, the patient received 20ml saline intravenous also 10 min before surgery.

Primary Outcome Measures

Name	Time	Method
Visual clarity during shoulder arthroscopic surgery.	Measure the whole surgery's mean visual clarity grade after surgery through study completion, an average of 1 year.	We use 3-grades visual clarity. grade 1 means poor visual clarity; 2 means fair clarity and 3 means good clarity. The visual clarity was scored in every 15 minutes during

Secondary Outcome Measures

Name	Time	Method
change of serum hemoglobin before and after operation	measure on post operative day one's morning through study completion, an average of 1 year.	use the change of Hb to calculate estimate blood loss by Gross formula.
post operation shoulder swelling	measure on post operative day one's morning through study completion, an average of 1 year.	(compared the circumference of shoulder post op day 1 to the day of admission which were measured at two sites: axillary and deltoid),
patients' visual analog scale (VAS ) pain score on postoperative day 1	measure on post operative day one's morning through study completion, an average of 1 year.	The visual analog scale(VAS) for pain is a continuous scale comprised of a horizontal line, which was 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme (from 0 cm means no pain to 10cm means worst pain possible) for patients self-assessment of pain.

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan