NCT04560010|TerminatedPhase 4ResultsDMCFDA Drug
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Enrollment rate was slower than anticipated
The Effect of Tranexamic Acid in Anticoagulated Patients Undergoing Total Shoulder Athroplasty
Sponsor study identifier
interventional
17
1 country
1
Study Start
October 6, 2020
Actual (reported)Primary Completion
March 11, 2023
Actual (reported)Study Completion
March 11, 2023
Actual (reported)This is a randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in anticoagulated patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing anatomical and reverse total shoulder arthroplasty (TSA). Patients will be randomized to either receive 2 doses of IV TXA, first dose prior to surgical incision and second dose given 3 hours later or to the control group, where no TXA will be administered.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 11, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 17, 2020
Actual (reported)September 23, 2020
Actual (reported)October 6, 2020
Actual (reported)March 11, 2023
Actual (reported)March 11, 2023
Actual (reported)March 26, 2024
Actual (reported)Calculated Total Blood Loss
"The volume of perioperative blood loss will be determined on the basis of the blood volume and change in hemoglobin from preoperatively to 1 day postoperatively. The volume of total perioperative blood loss will be determined according to the following formula: Total blood loss (ml) = 1000 x 〖Hb〗\_loss/〖Hb〗\_i"
Baseline to 24 hours post op
Total Surgical Drain Output
Surgical drain output will be recorded by floor nurse every 8 hours in EPIC. Data will be recorded up to 24 hours post-op if needed.
Up to 24 hours post-op
Number of Participants With Presence of Hematoma
2 weeks post-op
Number of Participants Who Needed a Post-op Blood Transfusion
Up to 24 hours post-op
Average Operative Time
During operation, up to 4 hours
Number of Patients Who Developed Adverse Events Such as Myocardial Infarction (MI), Pulmonary Embolus (PE), and/or Deep Vein Thrombosis (DVT)
Up until 30 days after last day of study participation, an average of 6 weeks
Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.
Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA.
Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
NYU Langone Health
New York, New York, 10016, United States
Arthur Hertling, MD
NYU Langone Health
17 participants (actual enrollment reported by the registry).
First Submitted
Contact the study team to confirm eligibility.
September 17, 2020
First Posted
September 23, 2020
Study Start
October 6, 2020
Actual (reported)Primary Completion
March 11, 2023
Actual (reported)Study Completion
March 11, 2023
Actual (reported)Last Updated
March 26, 2024
Results First Posted
March 26, 2024
Record last verified: 2024-02
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Source: ClinicalTrials.gov.
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