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Does Modified Ultrafiltration Affect Thromboelastography Results?

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

Congenital Heart Disease

Study type

Observational

Funder types

Other

Identifiers

NCT03214120
K5900405

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

1 day to 1 month old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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