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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The participating anesthesiologists will not be blinded to study arms and hypotheses. Dr.
      Christopher Edmonds will be the head anesthesiologist for this study and will administer
      anesthetics to participants in this trial whenever his schedule makes it possible. Anesthesia
      will be conducted in a standardized fashion, with IV sedation using Versed and IV propofol,
      +/- Fentanyl and Ketamine . A Combined Spinal-Epidural (CSE) will be placed using 12.5-20 mg
      of bupivacaine. If a CSE is unsuccessful and an epidural and/or spinal are successfully
      obtained, the patient may still be included in the study. Patients not receiving neuraxial
      anesthesia will be excluded. If a patient requires general anesthesia, it will be induced at
      this time, but the patient will be excluded from the study. An arterial line and additional
      venous access will be obtained in standardized sterile practice. Sedation will be maintained
      with IV propofol. IV Valium, Toradol and IV acetaminophen will be given towards the end of
      the case, per anesthesiologist's discretion.

      The blood pressure target will be 20-25% below baseline, which will be achieved primarily
      with the neuraxial anesthesia. For blood pressure above this range, the epidural will be
      dosed with a short-acting local anesthetic, and/or IV sedation will be titrated as per the
      anesthesiologist's judgment. For hypotension below this range, pressors or intravenous
      pressors will be given. An IV fluid bolus may also be given in the amount of 10-20cc/kg.
      Additional maintenance IV fluids will be given to maintain urine output of at least
      0.5-1ml/kg/hr. The criteria for transfusion of blood products will be a hemoglobin level of <
      7.0 g/dL or a hemoglobin level of < 10.0 g/dL with clinical signs of symptomatic anemia
      (e.g., unexplained tachycardia, hypotension unresponsive to fluids or vasopressors, change in
      mental status, low urine output, and shortness of breath). Blood will be administered 1 unit
      at a time, and the presence of symptoms or signs will be reassessed after each unit. This
      algorithm may be altered by the treating physician (e.g., PACU attending, surgeon, or the OR
      anesthesiologist), however all decisions will be supported by reasonable documentation.
      Drains will be removed on POD 2 unless specified by the attending surgeon. Of note, the chart
      of the patient will clearly indicate him/her as a study patient; a sticker will be place on
      the front of each participating patient's chart. Their enrollment will also be communicated
      in the clinician rounding notes for each patient. Drains will be labeled for each study
      participant as well, and nurses will record the drain outputs per their floor protocol.

      Attending surgeons, orthopedic surgery residents, physician assistants and research
      assistants involved with this study will assist in data collection. For each patient, we will
      collect demographic data, pre-operative CBC data, intra-operative cell saver auto-transfusion
      volumes, post-operative number of packed red blood cell units transfused, post-operative CBC
      data, post-operative drain outputs, and post-operative complications. This information will
      be gathered from the peri-operative medical records and electronic medical records. Surgeons
      and clinical and research personnel will review medical chart and progress notes for evidence
      of clinically significant VTE, reoperation, hematoma, seroma, and infection.
    

Intervention name(s): E-Aminocaproic acid
Intervention type(s): Drug
Intervention description(s): 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}
Other intervention name(s): EACA
Intervention MeSH terms: Aminocaproic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: E-Aminocaproic Acid; Bilateral Varus Rotational Osteotomy; Blood Loss and Transfusion; Complications; Safety