Does Modified Ultrafiltration Affect Thromboelastography Results?

Completed

• Conditions: Congenital Heart Disease

• Registration Number: NCT03214120
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Study Start: 2018-01-08
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• neonates

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

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Exclusion Criteria

-patients older than 1 month.

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Advocate Children's Hospital; 🇺🇸 Oak Lawn, Illinois, United States