Rotator Cuff Tears Clinical Trial
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
Verified date | July 2019 |
Source | National Cheng-Kung University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | February 28, 2018 |
Est. primary completion date | February 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Cheng Kung University Hospital | Tainan |
Lead Sponsor | Collaborator |
---|---|
National Cheng-Kung University Hospital |
Taiwan,
Felli L, Revello S, Burastero G, Gatto P, Carletti A, Formica M, Alessio-Mazzola M. Single Intravenous Administration of Tranexamic Acid in Anterior Cruciate Ligament Reconstruction to Reduce Postoperative Hemarthrosis and Increase Functional Outcomes in — View Citation
Karaaslan F, Karaoglu S, Yurdakul E. Reducing Intra-articular Hemarthrosis After Arthroscopic Anterior Cruciate Ligament Reconstruction by the Administration of Intravenous Tranexamic Acid: A Prospective, Randomized Controlled Trial. Am J Sports Med. 2015 — View Citation
Kirsch JM, Bedi A, Horner N, Wiater JM, Pauzenberger L, Koueiter DM, Miller BS, Bhandari M, Khan M. Tranexamic Acid in Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2017 Sep;5(9):e3. doi: 10.2106/JBJS.RVW.17.00021. Review. — View Citation
van Montfoort DO, van Kampen PM, Huijsmans PE. Epinephrine Diluted Saline-Irrigation Fluid in Arthroscopic Shoulder Surgery: A Significant Improvement of Clarity of Visual Field and Shortening of Total Operation Time. A Randomized Controlled Trial. Arthro — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual clarity during shoulder arthroscopic surgery. | 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. | |
Primary | Visual clarity during shoulder arthroscopic surgery. | 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 | patients' visual analog scale (VAS ) pain score on postoperative day 1 | 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. | |
Secondary | post operation shoulder swelling | (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. | |
Secondary | change of serum hemoglobin before and after operation | 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. |
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