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Safety and Efficacy of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients

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ClinicalTrials.gov Identifier: NCT02751645
Recruitment Status : Active, not recruiting
First Posted : April 26, 2016
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
The Gerber Foundation
Information provided by (Responsible Party):
Weronika Crescini, MD, Oregon Health and Science University

Brief Summary:
The investigators primary objective is to determine if acute normovolemic hemodilution (ANH) for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period as compared to usual care. This study will enroll 24 pediatric heart surgery patients, aged 6 months to 3 years old undergoing either ANH prior to initiating cardiopulmonary bypass or the standard of care procedures for the use of cardiopulmonary bypass.

Condition or disease Intervention/treatment Phase
Cardiac Defect Procedure: Acute Normovolemic hemodilution Not Applicable

Detailed Description:
Blood transfusion has been associated with worse outcomes in pediatric cardiac surgical patients. The major complications associated with it include increased blood loss during and after surgery, kidney disease requiring dialysis, abnormal coagulation profile, increased vasopressor use, and increased time spent on the ventilator and in the intensive care unit. One strategy to minimize blood product administration is acute normovolemic hemodilution (ANH). The investigators primary aim is to determine if ANH for pediatric cardiac surgical patients decreases the volume of blood products transfused during surgery and the immediate post-operative period, compared to usual care. The investigators designed a randomized, controlled, open label study that equally assigns 24 pediatric cardiac surgery patients aged 6 months to 3 years into two groups to receive either ANH prior to initiating cardiopulmonary bypass or usual standard of care. Participants in the ANH arm of the study will have 10 ml/kg of blood removed following anesthetic induction. In order to maintain normal circulating volume, the collected blood will be replaced with an equal volume of 5% albumin. All participants will be treated with a standardized protocol aimed at blood conservation including the use of retrograde arterial and antegrade venous perfusion, small circuit size, intraoperative red blood cell salvage, and low hemoglobin targets to trigger transfusion.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Efficacy and Safety of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients
Actual Study Start Date : June 30, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
No Intervention: Standard of Care Control
This group will consist of all the participants that receive the standard of care treatment for elective surgical repair or palliation of their cardiac defect with the use of the cardiopulmonary bypass machine.
Experimental: Acute Normovolemic Hemodilution
This group will consist of all the participants that receive the acute normovolemic hemodilution prior to their elective surgical repair or palliation of their cardiac defect with the use of the cardiopulmonary bypass machine.
Procedure: Acute Normovolemic hemodilution
ANH is a technique in which a portion of the patients' own blood is removed before any surgical bleeding occurs. It is stored until the end of the operation, at which point it is returned to the patient.




Primary Outcome Measures :
  1. Effectiveness of ANH to decrease volume of blood products during surgery and the immediate post-operative period. [ Time Frame: 2 Days ]
    This will be measured by comparing the volume (mL/Kg body weight) of any blood products administered peri-operatively between the two groups.


Secondary Outcome Measures :
  1. Kidney function [ Time Frame: 2 days ]
    This will be measured by the change in creatinine on postoperative day 2 from the pre-operative baseline value

  2. Normalization of thromboelastogrpahy (TEG) MA value (maximum amplitude) [ Time Frame: 2 days ]
    This will be measured by thromboelastography (TEG) test following end of cardiopulmonary bypass

  3. Normalization of thromboelastography (TEG) R value (reaction time) [ Time Frame: 2 days ]
    This will be measured by thromboelastography (TEG) test following end of cardiopulmonary bypass

  4. Normalization of thromboelastography (TEG) Alpha Angle value [ Time Frame: 2 days ]
    This will be measured by thromboelastography (TEG) test following end of cardiopulmonary bypass

  5. Final hematocrit, platelet count, PT/PTT on ICU admission [ Time Frame: 1 day ]
    These lab values will be recorded and compared for each group.

  6. Hematocrit and platelet count on post-operative day 1 [ Time Frame: 1 days ]
    These lab values will be recorded and compared for each group.

  7. Time to end of vasoactive support in the first 24 hours post-operation. [ Time Frame: 1 days ]
    This value will be recorded and compared for each group.

  8. Duration of mechanical ventilation and ICU stay [ Time Frame: 8 days ]
    This value will be recorded and compared for each group.



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Ages Eligible for Study:   6 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed signed consent must be obtained by a legally authorized representative.
  • Must be undergoing an elective surgical repair or palliation of a cardiac defect with the use of the cardiopulmonary bypass machine.
  • Must be clinically stable at the time of evaluation for eligibility and on the day of randomization.

Exclusion Criteria:

  • Patients who carry a diagnosis of a bleeding disorder.
  • Patients who have an abnormal coagulation profile as evidenced by a preoperative coagulation screen.
  • Patients who have received a blood transfusion in the preceding 120 days.
  • Patients who have a diagnosis of a chromosomal abnormality.
  • Patients whose participation in the study is deemed unsafe by their primary care team.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751645


Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
The Gerber Foundation
Investigators
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Study Director: Miriam Treggiari, MD Oregon Health and Science University

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Responsible Party: Weronika Crescini, MD, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02751645     History of Changes
Other Study ID Numbers: IRB#: 11949
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share the data collected during this study.

Keywords provided by Weronika Crescini, MD, Oregon Health and Science University:
Pediatric
Cardiac
Surgery