Does Modified Ultrafiltration Affect Thromboelastography Results?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03214120

Enrollment

Registered

2017-07-11

Start date

2018-01-08

Completion date

2019-01-01

Last updated

2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

thromboelastography, 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 1 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
change in thromboelastography components after modified ultrafiltration	1 hour (time during surgery after doing modified ultrafiltration) to 2 days (postoperative recovery in intensive care unit)	effect of modified ultrafiltration on different components of thromboelastography

Secondary

Measure	Time frame	Description
blood products utilization during and after surgery	initial phase of recovery (2 days) in the intensive care unit after cardiac surgery	use of packed red cells, fresh frozen plasma and platelets during or after surgery

Countries

United States

Outcome results