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

Cardiac Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02751645
• Other study ID #: IRB#: 11949
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 30, 2016
• Est. completion date: May 31, 2020

Study information

• Verified date: May 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: May 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Defect

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	The Gerber Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of ANH to decrease volume of blood products during surgery and the immediate post-operative period.	This will be measured by comparing the volume (mL/Kg body weight) of any blood products administered peri-operatively between the two groups.	2 Days
Secondary	Kidney function	This will be measured by the change in creatinine on postoperative day 2 from the pre-operative baseline value	2 days
Secondary	Normalization of thromboelastogrpahy (TEG) MA value (maximum amplitude)	This will be measured by thromboelastography (TEG) test following end of cardiopulmonary bypass	2 days
Secondary	Normalization of thromboelastography (TEG) R value (reaction time)	This will be measured by thromboelastography (TEG) test following end of cardiopulmonary bypass	2 days
Secondary	Normalization of thromboelastography (TEG) Alpha Angle value	This will be measured by thromboelastography (TEG) test following end of cardiopulmonary bypass	2 days
Secondary	Final hematocrit, platelet count, PT/PTT on ICU admission	These lab values will be recorded and compared for each group.	1 day
Secondary	Hematocrit and platelet count on post-operative day 1	These lab values will be recorded and compared for each group.	1 days
Secondary	Time to end of vasoactive support in the first 24 hours post-operation.	This value will be recorded and compared for each group.	1 days
Secondary	Duration of mechanical ventilation and ICU stay	This value will be recorded and compared for each group.	8 days