Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid

Rotator Cuff Tears Clinical Trial

Official title:

Intravenous Administration of Tranexamic Acid Significantly Improved Clarity of Visual Field in Arthroscopic Shoulder Surgery. A Prospective, Double-blind and Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04025736
• Other study ID #: A-BR-106-017
• Status: Completed
• Phase: N/A
• Start date: June 7, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: July 2019
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Arthorscopy Surgery
• Surgical Blood Loss
• Tranexamic Acid

Intervention

Drug:
• Tranexamic Acid 100Mg/Ml Inj Vil 10Ml
Tranexamic acid (TXA) is a synthetic analog of the amino acid lysine which acts by competitively blocking the plasminogen lysine-binding site and inhibiting fibrinolysis. Several studies showed that TXA could reduce both blood loss and the amount of blood transfusion after shoulder arthroplasty surgeries.
• 0.9% Sodium Chloride Injection
Normal saline is a mixture of sodium chloride in water and has a number of uses in medicine. We use the same volume of normal saline as placebo.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Felli L, Revello S, Burastero G, Gatto P, Carletti A, Formica M, Alessio-Mazzola M. Single Intravenous Administration of Tranexamic Acid in Anterior Cruciate Ligament Reconstruction to Reduce Postoperative Hemarthrosis and Increase Functional Outcomes in — View Citation

Karaaslan F, Karaoglu S, Yurdakul E. Reducing Intra-articular Hemarthrosis After Arthroscopic Anterior Cruciate Ligament Reconstruction by the Administration of Intravenous Tranexamic Acid: A Prospective, Randomized Controlled Trial. Am J Sports Med. 2015 — View Citation

Kirsch JM, Bedi A, Horner N, Wiater JM, Pauzenberger L, Koueiter DM, Miller BS, Bhandari M, Khan M. Tranexamic Acid in Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2017 Sep;5(9):e3. doi: 10.2106/JBJS.RVW.17.00021. Review. — View Citation

van Montfoort DO, van Kampen PM, Huijsmans PE. Epinephrine Diluted Saline-Irrigation Fluid in Arthroscopic Shoulder Surgery: A Significant Improvement of Clarity of Visual Field and Shortening of Total Operation Time. A Randomized Controlled Trial. Arthro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual clarity during shoulder arthroscopic surgery.	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 the operation scoring system to evaluate visual clarity during arthroscopic surgery. 4 Grade 1 means poor visibility (active bleeding that the vision was too poor to perform the operation); Grade 2 means fair visibility (minor bleeding that can interfere vision but surgery can still perform); Grade 3 means good visibility (clear vision without obvious blood).	Measure the percentage of grade 3 visual clarity after surgery through study completion, an average of 1 year.
Primary	Visual clarity during shoulder arthroscopic surgery.	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	Measure the whole surgery's mean visual clarity grade after surgery through study completion, an average of 1 year.
Secondary	patients' visual analog scale (VAS ) pain score on postoperative day 1	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.	measure on post operative day one's morning through study completion, an average of 1 year.
Secondary	post operation shoulder swelling	(compared the circumference of shoulder post op day 1 to the day of admission which were measured at two sites: axillary and deltoid),	measure on post operative day one's morning through study completion, an average of 1 year.
Secondary	change of serum hemoglobin before and after operation	use the change of Hb to calculate estimate blood loss by Gross formula.	measure on post operative day one's morning through study completion, an average of 1 year.