Clinical trial NCT02751645: Safety and Efficacy of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients
Official title: The Efficacy and Safety of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Defect
Keywords: Pediatric
Cardiac
Surgery
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2016-04-26
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Effectiveness of ANH to decrease volume of blood products during surgery and the immediate post-operative period.
timeFrame: 2 Days
Secondary outcomes:
measure: Kidney function
timeFrame: 2 days
measure: Normalization of thromboelastogrpahy (TEG) MA value (maximum amplitude)
timeFrame: 2 days
measure: Normalization of thromboelastography (TEG) R value (reaction time)
timeFrame: 2 days
measure: Normalization of thromboelastography (TEG) Alpha Angle value
timeFrame: 2 days
measure: Final hematocrit, platelet count, PT/PTT on ICU admission
timeFrame: 1 day
measure: Hematocrit and platelet count on post-operative day 1
timeFrame: 1 days
measure: Time to end of vasoactive support in the first 24 hours post-operation.
timeFrame: 1 days
measure: Duration of mechanical ventilation and ICU stay
timeFrame: 8 days
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Miriam Treggiari, MD
role: STUDY_DIRECTOR
References: