Phase 3
N=284
Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population
Hip Fractures
Bottom Line
View on ClinicalTrials.gov: NCT03923959 ↗Enrolled (actual)
284
Serious AEs
1.4%
Results posted
Oct 2024
Primary outcome: Primary: Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells. — 118; 111 Participants — p=0.966
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tranexamic Acid Injectable Solution (Drug); Placebo (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Lancaster General Hospital
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells. |
118; 111 | 0.966 |
| SECONDARY Complication Rate |
43; 30 | 0.183 |
| SECONDARY Hospital Readmission |
11; 8 | 0.729 |
| SECONDARY Mortality Rate |
15; 11 | 0.655 |
| SECONDARY Length of Stay |
5; 4.8 | 0.7832 |
Summary
The overall design of the study is a prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.
Eligibility Criteria
Inclusion Criteria
- Provision of written informed consent
- Age > or = to 65 years
- Hip fracture location within the femoral neck, intertrochanteric, and subtrochanteric regions
- Indication for one of the following surgical interventions: hemiarthroplasty, total hip replacement, sliding plate and screw fixation, or intramedullary fixation
Exclusion Criteria
- Indication for closed reduction or percutaneous screw
- Allergy to TXA
- Cerebrovascular accident/stroke, active coronary disease/myocardial infarction, or deep vein thrombosis/pulmonary emboli within one (1) month of the fracture
- Presence of hypercoaguable disorder, including cancer (active disease), elevated blood homocysteine levels, antiphospholipid antibody syndrome and inherited protein deficiencies (antithrombin III, factor V Leiden, protein S & C deficiencies, prothrombin gene mutation)
Data sourced from ClinicalTrials.gov (NCT03923959). 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.