Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid

NCT04025736 | Completed DMC

• 1 other identifier: A-BR-106-017
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Tranexamic Acid; Shoulder Arthroscopy; Visual Clarity; Hemostasis

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (3)

• 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.

• post operation shoulder swelling

  measure on post operative day one's morning through study completion, an average of 1 year.

• change of serum hemoglobin before and after operation

  measure on post operative day one's morning through study completion, an average of 1 year.

Study Arms (2)

Patients received Tranexamic acid

EXPERIMENTAL

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.

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

Patients received same volume of saline

PLACEBO COMPARATOR

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

Drug: 0.9% Sodium Chloride Injection

Interventions

Tranexamic Acid 100Mg/Ml Inj Vil 10Ml DRUG

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.

Patients received Tranexamic acid

0.9% Sodium Chloride Injection DRUG

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.

Patients received same volume of saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Related Publications (4)

• 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. Arthroscopy. 2016 Mar;32(3):436-44. doi: 10.1016/j.arthro.2015.08.027.

  PMID: 26524933 RESULT

• 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 Nov;43(11):2720-6. doi: 10.1177/0363546515599629. Epub 2015 Sep 2.

  PMID: 26337246 RESULT

• 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 the Early Phase of Postoperative Rehabilitation: A Randomized Controlled Trial. Arthroscopy. 2019 Jan;35(1):149-157. doi: 10.1016/j.arthro.2018.07.050.

  PMID: 30611343 RESULT

• 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.

  PMID: 28902659 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries; Blood Loss, Surgical

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Inclusion criteria were 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. We excluded patients who did not provide permit, those had history of coagulopathy, who were under anticoagulation therapy before surgery, who had abnormal coagulation profile (prothrombin time or activated partial thromboplastin time) before surgery, who had renal or liver disorder, those who had uncontrolled hypertension (systolic pressure \>180 mmHg), or who were allergy to local anesthetic agent or Tranexamic acid.

Study Record Dates

• First Submitted: July 14, 2019
• First Posted: July 19, 2019
• Study Start: June 7, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TW (1)