N/A
N=110
Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty
Blood Loss · Anatomic Total Shoulder Arthroplasty · Reverse Total Shoulder Arthroplasty · Transfusion · Tranexamic Acid
Bottom Line
View on ClinicalTrials.gov: NCT02569658 ↗Enrolled (actual)
110
Serious AEs
0.9%
Results posted
May 2017
Primary outcome: Primary: Post-operative Blood Loss — 152.2; 178.0 mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tranexamic Acid (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Blood Loss |
152.2; 178.0 | — |
| SECONDARY Number of Units Transfused |
0; 0 | — |
| SECONDARY Number of Patients Transfused |
0; 0 | — |
| SECONDARY Number of Participants With Deep Vein Thrombosis |
0; 1 | — |
| SECONDARY Number of Participants With Pulmonary Embolism |
0; 0 | — |
| SECONDARY Number of Participants With Stroke |
0; 0 | — |
Summary
To compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries.
Eligibility Criteria
Inclusion Criteria
- Any patient scheduled for a primary anatomic or reverse TSA
Exclusion Criteria
- Allergy to TXA
- Acquired disturbances of color vision
- Pre-op use of anticoagulant therapy within five days before surgery
- History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA
- Pregnancy or breastfeeding
- Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement
- Renal impairment
- Refusal of blood products
- Any patient undergoing a revision TSA
- Patients who decline to participate
Data sourced from ClinicalTrials.gov (NCT02569658). 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.