Phase 3
N=116
Tranexamic Acid in Reverse Total Shoulder Arthroplasty
Shoulder Joint Disease · Complications; Arthroplasty · Intraoperative Complications · Blood Loss, Surgical
Bottom Line
View on ClinicalTrials.gov: NCT02043132 ↗Enrolled (actual)
116
Serious AEs
1.0%
Results posted
Jun 2017
Primary outcome: Primary: Total Blood Loss — 1122.4; 1472 Total Blood Loss (mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tranexamic Acid (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Corewell Health East
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Blood Loss |
1122.4; 1472 | — |
| PRIMARY Total Hemoglobin Loss |
154.6; 200.1 | — |
| PRIMARY Total Drain Output |
221; 372 | — |
| SECONDARY Number of Participants Experiencing Pulmonary Embolism |
0; 0 | — |
| SECONDARY Number of Participants Experiencing Myocardial Infarction |
0; 1 | — |
| SECONDARY Number of Participants Experiencing Deep Vein Thrombosis |
0; 0 | — |
| SECONDARY Number of Participants Experiencing Hematoma as a Surgical Site Complication |
0; 0 | — |
| SECONDARY Number of Participants Experiencing Infection as a Surgical Site Complication |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing scheduled primary reverse total shoulder arthroplasty performed by J. Michael Wiater, MD.
- Patients age 18 and older
Exclusion Criteria
- Pregnant* or breast-feeding women
- Allergy to tranexamic acid
- Acquired disturbances of color vision
- Use of estrogen containing medications (i.e. oral contraceptive pills)
- Hormone replacement therapy
- Preoperative anemia [Hemoglobin (Hb) 1.4
- Partial Thromboplastin Time (PTT) > 1.4 times normal
- A history of arterial or venous thromboembolism
- Cerebral Vascular Accident
- Deep Vein Thrombosis
- Pulmonary Embolism
- Subarachnoid hemorrhage
- Active intravascular clotting
- Major comorbidities
- Coronary artery disease (New York Heart Association Class III or IV)
- Previous MI
- Severe pulmonary disease (FEV 115 μmol/L in males, > 100 μmol/L in females, or hepatic failure)
- Participation in another clinical trial 35. *All women of child bearing potential must have a negative serum or urine pregnancy test.
Data sourced from ClinicalTrials.gov (NCT02043132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.