NCT04456751

Brief Summary

In pediatric cardiac surgery, transfusion requirements are associated with age, development status, pathology, type of surgical intervention and extracorporeal bypass. In adult cardiac surgery, reinterventions (redo)are clearly linked to higher transfusion rates. The investigators want to study if this association is also true in pediatric cardiac surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,439

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 2, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

June 25, 2020

Last Update Submit

August 25, 2020

Conditions

Pediatric Cardiac SurgeryTransfusion

Outcome Measures

Primary Outcomes (1)

  • Transfusion of packed red cells (mL/kg)

    Transfusion requirements will be measured as volume of packed red cells given as mL packed red cells/kg of body weight

    Day of operation up to 5 days postop

Study Arms (2)

No redo op

Patients with a single cardiac operation under extracorporeal bypass

Redo op

Patients with a redo cardiac operation under extracorporeal bypass

Other: Redo op

Interventions

Redo opOTHER

Patients with a redo operation

Redo op

Eligibility Criteria

AgeUp to 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All patients between 0 and 16 years undergoing cardiac surgery with cardiopulmonary bypass in our institution. We will exclude Jehovah's witness patient as they refuse a transfusion.

You may qualify if:

  • Patients between 0 and 16 years
  • Cardiac surgery with cardiopulmonary bypass

You may not qualify if:

  • Jehova's witness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

Location

Study Officials

  • Denis Schmartz, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology department

Study Record Dates

First Submitted

June 25, 2020

First Posted

July 2, 2020

Study Start

July 2, 2020

Primary Completion

August 15, 2020

Study Completion

August 15, 2020

Last Updated

August 26, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)