Clinical trial NCT04650698: TXA in Revision Total Shoulder Arthroplasty
Official title: The Effect of Tranexamic Acid on Calculated Total Blood Loss in Patients Undergoing Revision Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Arthropathy Shoulder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing revision total shoulder arthroplasty. 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.

Detailed description: The objectives of the study are to compare the effectiveness of IV TXA on reducing calculated total blood loss, surgical drain output and hematoma formation in patients undergoing revision total shoulder arthroplasty.

Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 years old
2. Patients younger than 90 years old
3. Patients undergoing scheduled revision total shoulder arthroplasty
4. Patients who consent to be randomized

Exclusion Criteria:

1. Patients younger than 18
2. Patients older than 90 years old
3. Patients who are pregnant or breast-feeding women
4. Patients who are allergic to tranexamic acid
5. Patients with proximal humerus fracture or fracture sequelae
6. Patients who use estrogen containing medications (i.e. oral contraceptive pills)
7. Patients who have acquired disturbances of color vision
8. 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 \[Hemoglobin (Hb) \< 11g/dL in females, Hb \< 12 g/dL in males\]
9. Patients who refuse blood products
10. Patients undergoing hormone replacement therapy
11. Patients with diagnosed or self-reported cognitive dysfunction;
12. Patients who are unable to understand or follow instructions;
13. Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
14. Patients with BMI over 50
15. Any patient that the investigators feel cannot comply with all study related procedures.

Primary outcomes:
measure: Total Calculated Total Blood Loss
timeFrame: up 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: 2 weeks post-op
measure: Average Operative Time
timeFrame: During operation, up to 4 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Orthopedic Hospital
state: New York
Study officials:
affiliation: NYU Langone Health
name: Arthur Hertling, MD
role: PRINCIPAL_INVESTIGATOR
References: