Intravenous Administration of Tranexamic Acid Significantly Improved Clarity of Visual Field in Arthroscopic Shoulder Surgery. A Prospective, Double-blind and Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Visual clarity during shoulder arthroscopic surgery.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml (Drug)
Patients received same volume of saline
In the control group, the patient received 20ml saline intravenous also 10 min before surgery.
Intervention: 0.9% Sodium Chloride Injection (Drug)
Outcomes
Primary Outcomes
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
- change of serum hemoglobin before and after operation(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.)
- 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.)