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

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ClinicalTrials.gov Identifier: NCT02257580
Recruitment Status : Active, not recruiting
First Posted : October 6, 2014
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Tracking Information
First Submitted Date  ICMJE September 29, 2014
First Posted Date  ICMJE October 6, 2014
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE April 1, 2015
Estimated Primary Completion Date November 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
Intraoperative calculated total blood loss [ Time Frame: Post-Surgery, an expected average of 1 week ]
Post-surgery. determined by estimated blood volume, change in postoperative hemoglobin (preoperative hemoglobin - postoperative hemoglobin), and transfused hemoglobin. Length of stay may vary from days to months, depending on the severity of injury or if serious complication occurs.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02257580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
  • Intraoperative cell saver utilization [ Time Frame: Post-Surgery, an expected average of 1 week ]
    cumulative mL of reinfusion, measured intraoperatively at the end of the case
  • Postoperative allogeneic blood transfusion [ Time Frame: Post-Surgery, an expected average of 1 week ]
    units of packed red blood cells per patient
  • Post operative blood loss [ Time Frame: Post-Surgery, an expected average of 1 week ]
    24 hour drain output (mL)
  • Length of hospital stay [ Time Frame: Post-Surgery, an expected average of 1 week ]
    postoperative day of discharge after surgery- day of intake.
  • Complications [VTE (symptomatic of DVT or PE), infection (superficial, deep), hematoma, seroma, reoperation, and death] [ Time Frame: an expected average of 1 week (post-surgery), Follow-up at 6 weeks ]
    Incidence of VTE (symptomatic of DVT or PE), infection (superficial, deep), hematoma, seroma, reoperation, and death, measured in person-years ( x cases per 100,000 person years)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Intravenous EACA on Blood Loss and Transfusion Requirements After Bilateral VRO
Official Title  ICMJE The Effect of Intravenous E-Aminocaproic Acid (EACA) on Blood Loss and Transfusion Requirements After Bilateral Varus Rotational Osteotomy (VRO)
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • E-Aminocaproic Acid
  • Bilateral Varus Rotational Osteotomy
Intervention  ICMJE 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}
Other Name: EACA
Study Arms  ICMJE
  • Experimental: E-Aminocaproic acid (EACA)
    An EACA loading dose of 100 mg/kg with a max of 4-5 grams will be given up to 1 hour prior to incision. During the case, an EACA infusion of 33 mg/kg/hr (max of 1 gram/hr) will be maintained. The use of EACA will be terminated at the end of the case.
    Intervention: Drug: E-Aminocaproic acid
  • Placebo Comparator: Placebo
    Equivalent volume of normal saline prepared by the pharmacy.
    Intervention: Drug: E-Aminocaproic acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 2, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date November 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02257580
Other Study ID Numbers  ICMJE 2014-303
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospital for Special Surgery, New York
Study Sponsor  ICMJE Hospital for Special Surgery, New York
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Scher, MD Hospital for Special Surgery, New York
PRS Account Hospital for Special Surgery, New York
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP