TXA in Revision Total Shoulder Arthroplasty

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-07

Study Completion Date

2023-03-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arthropathy Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Neither the anesthesiologist or surgeon will be blinded to the patient's group assignment, as they will be the one performing the treatment. All other stakeholders (patient, other caregivers, and research staff collecting the data) will be blinded to the patient's group assignment.

Study Groups

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Tranexamic acid (TXA) Injection

Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.

Group Type EXPERIMENTAL

Tranexamic acid (TXA) injection

Intervention Type DRUG

IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)

Control - No Tranexamic acid (TXA) Injection

Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tranexamic acid (TXA) injection

IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)

Intervention Type DRUG

Other Intervention Names

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TXA

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No