Phase 4
Completed N=138
Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery?
Source: ClinicalTrials.gov NCT01714336 ↗Enrolled (actual)
138
Serious AEs
21.0%
Results posted
May 2016
Primary outcomePrimary: Number of Participants Who Received a Hospitalization Transfusion — 18; 12 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Does tranexamic acid improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Received a Hospitalization Transfusion |
18; 12 | — |
| SECONDARY Mean Number of Units Transfused |
1.8; 1.2 | — |
| SECONDARY Calculated Blood Loss |
1214; 902 | — |
| SECONDARY Number of Participants With Venous Thromboembolism (VTE) Diagnosis |
2; 3 | — |
| SECONDARY Number of Participants With Wound Complications |
2; 5 | — |
| SECONDARY Number of Participants With Myocardial Infarction (MI) Diagnosis |
3; 2 | — |
| SECONDARY Number of Participants With Cerebrovascular Accident (CVA) Diagnosis |
0; 1 | — |
| SECONDARY Number of Participants Who Died |
11; 10 | 0.75 |
Eligibility Criteria
Inclusion criteria
- AO/OTA (Orthopedic Trauma Association) fracture classification 31B
- Surgically treated with either hemiarthroplasty or total hip arthroplasty
- Acute fracture treated within 72 hours of injury
- Low energy isolated injury
- Age greater than 18 years old
Exclusion Criteria
- Transfusion received during admission, prior to surgery
- Creatinine clearance less than 30 mL/min
- History of unprovoked Venous Thromboembolism (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 cerebrovascular accident (CVA), Myocardial infarction (MI), or VTE within the previous 30 days
- Coronary stent placement within the previous 6 months
- Disseminated intravascular coagulation
- Subarachnoid hemorrhage
Data sourced from ClinicalTrials.gov (NCT01714336). 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. Informational only — not medical advice.