Clinical trial NCT04025736: Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Shoulder Arthorscopy Surgery
Surgical Blood Loss
Tranexamic Acid
Keywords: Tranexamic Acid
Shoulder Arthroscopy
Visual Clarity
Hemostasis
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 \&gt;180 mmHg), or who were allergy to local anesthetic agent or Tranexamic acid.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 \&gt;180 mmHg)
* Allergy to local anesthetic agent or TXA.

Primary outcomes:
measure: Visual clarity during shoulder arthroscopic surgery.
timeFrame: Measure the percentage of grade 3 visual clarity after surgery through study completion, an average of 1 year.
measure: Visual clarity during shoulder arthroscopic surgery.
timeFrame: Measure the whole surgery's mean visual clarity grade after surgery through study completion, an average of 1 year.
Secondary outcomes:
measure: patients' visual analog scale (VAS ) pain score on postoperative day 1
timeFrame: measure on post operative day one's morning through study completion, an average of 1 year.
measure: post operation shoulder swelling
timeFrame: measure on post operative day one's morning through study completion, an average of 1 year.
measure: change of serum hemoglobin before and after operation
timeFrame: measure on post operative day one's morning through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
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. Arthroscopy. 2016 Mar;32(3):436-44. doi: 10.1016/j.arthro.2015.08.027.
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 Nov;43(11):2720-6. doi: 10.1177/0363546515599629. Epub 2015 Sep 2.
citation: 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 the Early Phase of Postoperative Rehabilitation: A Randomized Controlled Trial. Arthroscopy. 2019 Jan;35(1):149-157. doi: 10.1016/j.arthro.2018.07.050.
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.