Clinical trial NCT04560010: TXA in Anticoagulated Patients Study
Official title: The Effect of Tranexamic Acid in Anticoagulated Patients Undergoing Total Shoulder Athroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Total Shoulder Athroplasty
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects scheduled to undergo TSA (anatomic and reverse) will be randomized to receive one of two treatment options. This study will utilize a simple randomization approach to generate two-equal groups. All subjects have an equal chance (1:2) of getting randomized into one of the twp treatments groups: (1) Two doses of IV TXA, one before incision and the second 3 hours later. (2) control group - no TXA given. Randomization of each subject will be done on day of surgery. The randomization schedule will be generated using a computer software program such as randomization.com
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria

* Patients older than 18 years old
* Patients undergoing scheduled primary anatomic total shoulder arthroplasty
* Patients undergoing scheduled primary reverse total shoulder arthroplasty
* Patients who consent to be randomized
* Preoperative use of anticoagulant or antiplatelet therapy within 10 days prior to surgery:

  * Coumadin (Warfarin)
  * Heparin
  * Low molecular weight heparin
  * Factor Xa inhibitors
  * Apixaban (Eliquis)
  * Rivarixaban (Xatelto)
  * Edoxaban (Savaysa)
  * Dabigatran (Pradaxa)
  * Clopidogrel (Plavix)
  * Prasugrel (Effient)
  * Ticagrelor (Brilinta)

Exclusion Criteria

* Patients younger than 18
* Patients who are pregnant\* or breast-feeding women
* Patients who are allergic to tranexamic acid
* Patients scheduled for revision total shoulder arthroplasty
* Patients with proximal humerus fracture or fracture sequelae
* Patients who use estrogen containing medications (i.e. oral contraceptive pills)
* Patients who have acquired disturbances of color vision
* Patients with a history of any of the following diagnosis: '

  * Subarachnoid hemorrhage
  * Active intravascular clotting
  * Severe pulmonary disease (FEV \<50% normal)
  * Plasma creatinine \> 115 μmol/L in males, \> 100 μmol/L in females, or hepatic failure)
  * (Renal impairment serum creatinine \> 1.5 times the upper limit of normal NYU)
  * Preoperative anemia \[Hemoglobin (Hb) \< 11g/dL in females, Hb \< 12 g/dL in males\]
* Patients who refuse blood products
* Patients undergoing hormone replacement therapy
* Patients with diagnosed or self-reported cognitive dysfunction;
* Patients who are unable to understand or follow instructions;
* Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
* Patients with BMI over 50
* Any patient that the investigators feel cannot comply with all study related procedures.

Primary outcomes:
measure: Calculated Total Blood Loss
timeFrame: Baseline to 24 hours post op
measure: Total Surgical Drain Output
timeFrame: Up to 24 hours post-op
Secondary outcomes:
measure: Number of Participants With Presence of Hematoma
timeFrame: 2 weeks post-op
measure: Number of Participants Who Needed a Post-op Blood Transfusion
timeFrame: Up to 24 hours post-op
measure: Average Operative Time
timeFrame: During operation, up to 4 hours
measure: Number of Patients Who Developed Adverse Events Such as Myocardial Infarction (MI), Pulmonary Embolus (PE), and/or Deep Vein Thrombosis (DVT)
timeFrame: Up until 30 days after last day of study participation, an average of 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Arthur Hertling, MD
role: PRINCIPAL_INVESTIGATOR
References: