The Effect of Intravenous EACA on Blood Loss and Transfusion Requirements After Bilateral VRO
Condition: E-Aminocaproic Acid; Bilateral Varus Rotational Osteotomy
MeSH terms: Hemorrhage
Intervention: E-Aminocaproic acid
Intervention description: 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}
Intervention MeSH terms: Aminocaproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: E-Aminocaproic Acid; Bilateral Varus Rotational Osteotomy; Blood Loss and Transfusion; Complications; Safety

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.
    

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