Phase 4
Completed N=28
The Effect of Intravenous EACA on Blood Loss and Transfusion Requirements After Bilateral VRO
E-Aminocaproic Acid · Bilateral Varus Rotational Osteotomy
Source: ClinicalTrials.gov NCT02257580 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Intraoperative Calculated Total Blood Loss — 535.7; 628.0 mL
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
E-Aminocaproic acid (EACA) is an anti-fibrinolytic agent that is used to decrease blood loss and transfusion requirements after several orthopedic procedures. The aim of this prospective double-blind placebo-controlled randomized trial is to determine whether IV EACA reduces intra-operative calculated total blood loss in patients undergoing bilateral varus rotational osteotomy (VRO). This study will also investigate intraoperative cell saver utilization, transfusion of allogeneic blood, hospital length-of-stay (LOS), short term complications, and long-term outcomes.This study will provide Level I evidence and has the potential to improve outcomes in children undergoing this procedure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Calculated Total Blood Loss |
535.7; 628.0 | — |
| SECONDARY Intraoperative Cell Saver Utilization |
7; 7 | — |
| SECONDARY Postoperative Allogeneic Blood Transfusion |
4; 3 | — |
| SECONDARY Post Operative Blood Loss |
72.5; 103.3 | — |
| SECONDARY Length of Hospital Stay |
5.5; 5.1 | — |
| SECONDARY Complications [VTE (Symptomatic of DVT or PE), Infection (Superficial, Deep), Hematoma, Seroma, Reoperation, and Death] |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Scheduled for bilateral varus rotational osteotomy (VRO) with or without associated soft tissue and osseous procedures
Exclusion Criteria
- Preoperative use of an anticoagulant (Plavix, warfarin, lovenox, etc.)
- History of hypersensitivity to EACA
- History of thromboembolic event (e.g., PE or DVT)
- History of renal insufficiency or failure
- Congenital or acquired coagulopathy as evidence by INR >1.4 or PTT > 1.4 times normal, or Platelets <150,000/mm3 on preoperative laboratory testing
- Use of hormone replacement therapy or hormonal contraceptive agents within days prior to surgery
- Use of acetylsalicylic acid (ASA), antiplatelet agents within 7 days prior to surgery
- Pregnant
- Breastfeeding
- Not received neuraxial anesthesia
Data sourced from ClinicalTrials.gov (NCT02257580). 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.