Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-07

Study Completion Date

2018-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Arthroscopic Rotator Cuff Repair Performed With Intraarticular Tranexamic Acid Could it Provide Improved Visual Clarity and Less Post-operative Pain? A Prospective, Double Blind, Randomized Study of 64 Patients.

NCT05453266

Rotator Cuff Tears Rotator Cuff Rupture Tranexamic Acid +2 more

COMPLETED NA

Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery

NCT04594408

Rotator Cuff Injuries Rotator Cuff Tears Subacromial Impingement +1 more

COMPLETED PHASE4

The Aim of This Study is to Examine the Effect of Intravenously Administered Tranexamic Acid (TXA) on the Visual Clarity, Perioperative Hemorrhage, Duration and Early Postoperative Course of Shoulder Arthroscopy in Beach Chair Position.

NCT05397652

Rotator Cuff Tears Hemorrhage, Surgical Shoulder Injuries

COMPLETED PHASE4

The Effect of Tranexamic Acid (TXA) on Visualization During Shoulder Arthroscopy

NCT04610164

Shoulder Arthroscopy Operative Bleeding Postoperative Pain

UNKNOWN PHASE3

Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty

NCT02569658

Blood Loss Anatomic Total Shoulder Arthroplasty Reverse Total Shoulder Arthroplasty +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rotator Cuff Tears Shoulder Arthorscopy Surgery Surgical Blood Loss Tranexamic Acid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Tranexamic Acid 100Mg/Ml Inj Vil 10Ml

Intervention Type 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 same volume of saline

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

Group Type PLACEBO_COMPARATOR

0.9% Sodium Chloride Injection

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No