Phase 3
Completed N=87
The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery
Source: ClinicalTrials.gov NCT02684851 ↗Enrolled (actual)
87
Serious AEs
1.2%
Results posted
Jan 2021
Primary outcomePrimary: Allogenic Blood Transfusion Rates — 21; 13 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 This can indicate results are unpublished — a known publication-bias signal.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
The purpose of this study is to determine if patients undergoing acetabular ORIF (open reduction with internal fixation) who receive tranexamic acid have a reduced risk of allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for thromboembolic events compared to patients who receive placebo. Investigators want to determine the cost-effectiveness related to allogenic blood transfusion as a blood loss management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic surgery carries with it a significant risk for blood loss. Current management of perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse reactions. There have been significant efforts to reduce the use of allogenic blood transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been used in management of blood during surgery. In order to determine the impact of tranexamic acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will conduct a prospective randomized study. Patients undergoing acetabular surgery will be screened for this study. Patients will be then randomized to placebo or tranexamic acid which will be administered during and after surgery. The following data will be collected: patient characteristics, surgery information, blood loss, blood transfusions, wound complication within 30 days of surgery, and cost.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Allogenic Blood Transfusion Rates |
21; 13 | — |
| PRIMARY Units of Packed Red Blood Cells Transfused |
2.65; 2.36 | — |
| SECONDARY Number of Participants With a Thromboembolic Event |
1; 0 | — |
| SECONDARY Estimate Blood Loss |
727.6; 560.1 | — |
Eligibility Criteria
Inclusion Criteria
- All patients aged 18 or above undergoing acetabular ORIF.
Exclusion Criteria
- All patients aged below 18 years undergoing acetabulum surgery
- Patients with color-blindness (color vision changes used to assess toxicity)
- Patients with subarachnoid hemorrhage.
- Patients with active intravascular coagulation.
- Patients with a previous history of venous thromboembolism or with a history of hypercoaguable conditions (i.e. Factor V Leiden, antiphospholipid antibody).
- Prisoners
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT02684851). 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.