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NCT02257580 · ClinicalTrials.gov registry record · Phase 4
The Effect of Intravenous EACA on Blood Loss and Transfusion Requirements After Bilateral VRO
A Phase 4 study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT02257580: Completed Phase 4 study, sponsored by Hospital for Special Surgery, New York.
NCT02257580 is a Phase 4 study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02257580, a Phase 4 study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study 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.
Primary Outcome
Determined by estimated blood volume, calculated using difference in preoperative and postoperative hemoglobin and applied to the Nadler equation for estimating blood volume while adjusting for transfused hemoglobin to produce a single metric of calculated intraoperative blood loss.
Interventions
- DRUG E-Aminocaproic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2015-04-01 |
| Est. Completion | 2020-10-26 |
| Phase | Phase 4 |
What the finished NCT02257580 record still lists
NCT02257580 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which E-Aminocaproic acid is the first listed.
NCT02257580 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02257580 about?
NCT02257580 is a clinical study titled "The Effect of Intravenous EACA on Blood Loss and Transfusion Requirements After Bilateral VRO". 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 calculat...
What is the current status of trial NCT02257580?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2015-04-01. Estimated completion is 2020-10-26.
What interventions are being tested in trial NCT02257580?
The interventions under investigation include: E-Aminocaproic acid (DRUG).
Who is sponsoring clinical trial NCT02257580?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02257580's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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