Clinical Trials Logo

Clinical Trial Summary

To the Investigators' knowledge, TXA has not been studied in the setting of reverse total shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo in the setting of RTSA. The purpose of this study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates in patients undergoing reverse total shoulder arthroplasty.


Clinical Trial Description

Shoulder arthroplasty is a procedure used to relieve pain and dysfunction associated with arthritic destruction of the gleno-humeral joint. It has been demonstrated that in patients with concomitant rotator cuff deficiency, reverse total shoulder arthroplasty (rTSA) is an efficacious procedure that relieves pain as well as increases the lever-arm of the deltoid muscle, thus improving post-operative strength and range of motion.

However, perioperative blood loss in total shoulder arthroplasty can be significant, with an overall rate of allogeneic blood transfusion reported to be 7.4%-43% [1-5]. Patients undergoing reverse total shoulder arthroplasty are at even further risk of requiring a postoperative blood transfusion [2]. Blood transfusions are associated with significant risks to patient health that range from mild to life threatening.

Tranexamic acid (TXA) is an antifibrinolytic medication (reduces the destruction of blood clots, thus promoting the ability to stop bleeding) that is frequently used to reduce perioperative blood loss, blood transfusions and associated costs in major cardiac, vascular, obstetric, and orthopedic procedures. Currently, TXA is increasingly used in orthopedic joint reconstructive surgery and has proven to be safe and effective in reducing blood loss following total knee arthroplasty (TKA) and total hip arthroplasty (THA) [11-33]. Multiple recent meta-analyses have found that use of TXA in the setting of TKA and THA leads to significantly less overall blood loss and lower rates of blood transfusion without increasing rates of venous thromboembolism (VTE) or other complications [34-37]. TXA is now on formulary at William Beaumont Hospital.

100 patients slated to undergo elective reverse total shoulder arthroplasty will be recruited and randomized to receive either an infusion of the standard dose of TXA (10mg/kg) or placebo (an equivalent volume of normal saline) within 60 minutes prior to surgery and at wound closure.

Adult subjects 18 years of age or older will participate in this study after the objectives, methods, and potential hazards of the study have been fully explained, and after they have signed the informed consent form. The Investigator or designee is responsible for keeping a record of all subjects who sign an informed consent form for entry into this study

DATA AND SAFETY MONITORING PLAN Beaumont Research will follow their standard operating policy and procedure for establishing a group of designated Beaumont Hospital faculty that will be responsible for data and safety monitoring. This group will include a clinician, physician, scientific member and statistician. They will meet twice throughout the course of the study. A medical monitor was not appointed since this is a single-site study; Dr. J. Michael Wiater will personally oversee the health and well-being of all patients and submit AE reports, and the designated group will directly review all adverse event reports. Beaumont's Human Investigation Committee will review the data safety monitoring plan as part of their IRB approval process.

Study data will be transcribed by study personnel from the source documents into an electronic database maintained in Excel. The data collections forms are to be completed by the research nurse at the time of the data collection so that they always reflect the latest observations on the subjects participating in the study. Demographic data will be filled in preoperatively, intraoperative blood loss will be recorded in the OR, postoperative blood loss and transfusion will be collected retrospectively, and complications will be recorded as they occur or at 2 and 6 week follow-up. All data entries, corrections and alterations must be made by the investigator or other authorized study personnel. The Research Institute will complete internal auditing at random intervals during the study for data integrity, proper informed consent process implementation and documentation, protocol adherence, and patient safety reporting compliance to regulatory bodies.

Descriptive statistics will be provided for all data collected. Missing data will remain missing and will not be replaced by substitutions or interpolations. Statistical software (SPSS, IBM, Inc) will be used for all analyses. Baseline and demographic data will be compared between the 2 randomization arms to determine if any imbalances exist. Categorical variables will be shown as counts and % frequencies. They will be examined using Pearson's Chi-square where appropriate (expected frequency>5), otherwise a Fisher's Exact test will be used. Continuous variables will be examined for normality. Normally distributed variables will be analyzed using t-tests and non-normally distributed variables will be examined using non-parametric Wilcoxon rank tests. All continuous variables will be shown as means+/- the standard deviation followed by the median and (25th, 75th percentiles) where needed.

The primary outcome of intraoperative and postoperative blood loss and postoperative drop in Hb will be examined for normality. Normally distributed variables will be analyzed using t-tests and non-normally distributed variables will be examined using non-parametric Wilcoxon rank tests. Total number of postoperative transfusions and total number of patients requiring postoperative transfusions will be shown as counts and % frequencies. They will be examined using Pearson's Chi-square where appropriate (expected frequency>5), otherwise a Fisher's Exact test will be used.

The secondary outcomes of systemic and surgical site complications will be examined between the two randomization arms using Pearson's Chi-square where appropriate (expected frequency>5), otherwise a Fisher's Exact test will be used. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02043132
Study type Interventional
Source William Beaumont Hospitals
Contact
Status Completed
Phase Phase 2/Phase 3
Start date September 2013
Completion date February 2016

See also
  Status Clinical Trial Phase
Completed NCT04114253 - QStat in Liver Transplant
Recruiting NCT05077124 - Safe and Timely Antithrombotic Removal (STAR) Registry
Active, not recruiting NCT03651154 - Hypovolemic Phlebotomy to Reduce Blood Transfusions in Major Hepatic Resections N/A
Recruiting NCT04519593 - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma N/A
Withdrawn NCT00861367 - Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate N/A
Terminated NCT03246919 - Ideal Time of Oxytocin Infusion During Cesarean Section Phase 4
Completed NCT04443920 - Tranexamic Acid for Total Knee Arthroscopy Phase 4
Withdrawn NCT04933253 - Mediastinal Temperature and Post-operative Bleeding N/A
Recruiting NCT02938962 - Intravenous vs. Topical Tranexamic Acid in Revision THA (VITALITY-X) Phase 4
Recruiting NCT02130752 - Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery N/A
Recruiting NCT05164809 - Effect of Electrosurgery on Blood Loss and Intraoperative Transfusions in Musculoskeletal Tumor Surgery
Not yet recruiting NCT04574128 - Retransfusion or Not of Cardiotomy Blood N/A
Completed NCT02911831 - IV Tranexamic Acid Prior to Hysterectomy Early Phase 1
Completed NCT02740374 - Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery N/A
Enrolling by invitation NCT05474027 - Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery Phase 4
Completed NCT05391607 - Comparison Between Hyperoncotic and Isooncotic Albumin to Support Blood Loss Replacement Phase 4
Completed NCT03152461 - Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge
Recruiting NCT02441751 - Intraoperative Volume Management and QT Interval
Completed NCT01053169 - Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study) N/A
Completed NCT00656396 - Point of Care Coagulation Testing in Patients Undergoing Major Surgery Phase 3