Phase 4
N=36
Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty
Femoral Neck Fractures
Bottom Line
View on ClinicalTrials.gov: NCT02664909 ↗Enrolled (actual)
36
Serious AEs
8.3%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants Who Needed Transfusions — 0; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic Acid (Drug); Placebo (saline) (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- UConn Health
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Needed Transfusions |
0; 5 | — |
| SECONDARY Inpatient Transfusion Amount |
NA; 1.2 | — |
| SECONDARY Difference Between Pre/Post-operative Hemoglobin |
1.45; 1.48 | — |
| SECONDARY Difference Between Pre/Post-operative Hematocrit |
4.1; 4.4 | — |
| SECONDARY Length of Inpatient Hospital Stay |
3.9; 4.8 | — |
| SECONDARY Number of Participants With Post-operative Complications |
6; 11 | — |
| SECONDARY Inpatient Hospitalization Cost |
— | — |
Summary
This study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of 1 gram of topically applied tranexamic acid vs. saline placebo for the reduction of transfusion following hip hemiarthroplasty surgery.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing hip hemiarthroplasty surgery for a displaced femoral neck fracture
Exclusion Criteria
- History of hemophilia, history of deep vein thrombosis, history of pulmonary embolism, history of thrombophilia, history of chronic renal failure
- Patients with coronary ischemia (active or within the past calendar year), patients who have suffered a myocardial infarction, undergone percutaneous coronary intervention, undergone coronary artery bypass grafting, or undergone any revascularization procedure within the past calendar year
- Patients with active subarachnoid hemorrhage, acquired defective color vision, patients who sustained a pathologic fracture (fracture through a neoplastic lesion), or patients who are pregnant
- Patients with a known allergy to tranexamic acid
- Patients taking Warfarin, Dabigatran, Rivaroxaban, Apixaban, and Fresh Frozen Plasma
Data sourced from ClinicalTrials.gov (NCT02664909). 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.