Clinical trial NCT03214120: Does Modified Ultrafiltration Affect Thromboelastography Results?
Official title: Does Modified Ultrafiltration Affect Thromboelastography Results?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: thromboelastography, modified ultrafiltration
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates with congenital heart disease requiring cardiac surgery during the first month of life, with the use of cardiopulmonary bypass and modified ultrafiltration.

Brief summary: The study is to evaluate the effect of modified ultrafiltration on different components of Thromboelastography (TEG) in neonates undergoing cardiac surgery using cardiopulmonary bypass.

Detailed description: The study will be performed at Advocate Children's Hospital, Oak Lawn. All neonates undergoing cardiac operations with cardiopulmonary bypass and modified ultrafiltration will be enrolled. Parents will be consented before surgery.

After weaning from cardiopulmonary bypass and before starting modified ultrafiltration, a TEG sample will be taken. The components studied are Reaction time (R), Coagulation time (K), Angle, Maximum Amplitude (MA) and whole blood clot lysis index at 30 minutes (LY30). Another TEG sample will be taken after finishing modified ultrafiltration and before protamine is given. The different components will be compared pre and after modified ultrafiltration. The Primary end points are the changes of the different TEG components after modified ultrafiltration. The secondary end points are the utilization of different blood products (packed red cells, fresh frozen plasma and platelets transfusion) during and after surgery.

Eligibility criteria: Inclusion Criteria: - neonates

* congenital heart disease
* pediatric cardiac operation with cardiopulmonary bypass
* modified ultrafiltration done at the end of cardiopulmonary bypass

Exclusion Criteria: -patients older than 1 month.

* Cardiopulmonary bypass is not used
* Modified ultrafiltration is not performed

Primary outcomes:
measure: change in thromboelastography components after modified ultrafiltration
timeFrame: 1 hour (time during surgery after doing modified ultrafiltration) to 2 days (postoperative recovery in intensive care unit)
Secondary outcomes:
measure: blood products utilization during and after surgery
timeFrame: initial phase of recovery (2 days) in the intensive care unit after cardiac surgery
Other outcomes:
Locations:
city: Oak Lawn
country: United States
facility: Advocate Children's Hospital
state: Illinois
Study officials:
affiliation: Wake Forest University Health Sciences
name: Chawki Elzein, MD
role: PRINCIPAL_INVESTIGATOR
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