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The Effect of Intravenous EACA on Blood Loss and Transfusion Requirements After Bilateral VRO

NCT02257580 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-11-23

Study results available
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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.

Conditions

  • E-Aminocaproic Acid
  • Bilateral Varus Rotational Osteotomy

Interventions

DRUG

E-Aminocaproic acid

E-Aminocaproic acid (EACA) is a synthetic lysine analog that competitively inhibits the activation of plasminogen to plasmin and subsequently decreases the degree of fibrinolysis (Faraoni,2014} and is currently being used to decrease blood loss and transfusion requirements after orthopaedic procedures.(Eubanks,2010} Multiple meta analyses and retrospective and prospective studies have shown that EACA decreases blood loss and transfusion requirements after orthopaedic surgery{ McLeod,2013; Thompson, 2005; Thompson,2008; Gill,2008; Florentino-Pineda,2001}.Results from these studies also suggest that EACA will decreased post-operative morbidity, length of hospital stay, hospital costs, and complications.{Chimento,2013; Thompson,2005; Florentino-Pineda,2001}

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • David Scher, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2020-10-26
Completion
2020-10-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02257580 on ClinicalTrials.gov