Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid

July 17, 2019 updated by: National Cheng-Kung University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients received Tranexamic acid
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
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.
Placebo Comparator: Patients received same volume of saline
In the control group, the patient received 20ml saline intravenous also 10 min before surgery.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual clarity during shoulder arthroscopic surgery.
Time Frame: Measure the percentage of grade 3 visual clarity 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 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.
Time Frame: 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
Measure the whole surgery's mean visual clarity grade after surgery through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patients' visual analog scale (VAS ) pain score on postoperative day 1
Time Frame: 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.
measure on post operative day one's morning through study completion, an average of 1 year.
post operation shoulder swelling
Time Frame: 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),
measure on post operative day one's morning through study completion, an average of 1 year.
change of serum hemoglobin before and after operation
Time Frame: 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.
measure on post operative day one's morning through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2017

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

July 14, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-BR-106-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rotator Cuff Tears

Clinical Trials on Tranexamic Acid 100Mg/Ml Inj Vil 10Ml

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe