Phase 2
N=128
Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement
Hip Fractures · Intertrochanteric Fractures
Bottom Line
View on ClinicalTrials.gov: NCT03182751 ↗Enrolled (actual)
128
Serious AEs
11.7%
Results posted
Mar 2023
Primary outcome: Primary: Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells — 17; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tranexamic Acid (TXA) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells |
17; 19 | — |
| SECONDARY Number of Units of Packed Red Blood Cells Transfused |
1.9; 2.3 | — |
| SECONDARY Calculated Blood Loss |
1600; 2000 | — |
| SECONDARY Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE) |
3; 1 | — |
| SECONDARY Wound Complications |
4; 1 | — |
| SECONDARY (Myocardial Infarction) MI Diagnosed |
0; 2 | — |
| SECONDARY Cerebrovascular Accident (CVA) Diagnosed |
0; 3 | — |
| SECONDARY All-cause Mortality |
7; 6 | — |
Summary
Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.
Eligibility Criteria
Inclusion Criteria
- AO/OTA fracture classification 31A
- Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
- Low energy, isolated injury
Exclusion Criteria
- Intracapsular hip fractures: AO/OTA fracture classification 31B-C
- Polytrauma patients
- Creatinine clearance less than 30 mL/min
- History of unprovoked VTE and/or recurrent VTE
- Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
- Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
- History of CVA, MI, or VTE within the previous 30 days
- Coronary stent placement within the previous 6 months
- Disseminated intravascular coagulation
- Intracranial hemorrhage
Data sourced from ClinicalTrials.gov (NCT03182751). 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.