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Completed

NCT Number: NCT04025736

Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid

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.

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Key information

Conditions

Rotator Cuff Tears Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rupture Shoulder Arthorscopy Surgery Shoulder Injuries Surgical Blood Loss Tendon Injuries Tranexamic Acid Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

  2. 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

Secondary outcomes

  1. 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.

  2. 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),

  3. 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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 19, 2019
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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