Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid
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|ClinicalTrials.gov Identifier: NCT04025736|
Recruitment Status : Completed
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tears Shoulder Arthorscopy Surgery Surgical Blood Loss Tranexamic Acid||Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml Drug: 0.9% Sodium Chloride Injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intravenous Administration of Tranexamic Acid Significantly Improved Clarity of Visual Field in Arthroscopic Shoulder Surgery. A Prospective, Double-blind and Randomized Controlled Trial|
|Actual Study Start Date :||June 7, 2017|
|Actual Primary Completion Date :||February 28, 2018|
|Actual Study Completion Date :||February 28, 2018|
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.
- 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).
- 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
- 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.
- 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),
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025736
|National Cheng Kung University Hospital|
|Tainan, Taiwan, 704|