NCT05819788

Brief Summary

When small children undergo heart surgery with the heart-lung machine, in the past, blood products to help the blood clot such as Fresh Frozen Plasma (FFP) was routinely used in children under 10kg. With blood clot monitoring technology, we feel that it might not be necessary to expose all children to FFP. We want to determine if those children who did not receive FFP bleed more or require more blood products as compared to those who did receive FFP while on the heart lung machine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
431

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

August 28, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

April 6, 2023

Last Update Submit

September 6, 2024

Conditions

CoagulopathyCongenital Heart Disease

Outcome Measures

Primary Outcomes (2)

  • Transfusion

    Units of blood products transfused

    24 hours

  • Bleeding

    Chest tube output

    24 hours

Secondary Outcomes (2)

  • Length of ventilation

    5 days

  • Length of stay

    5 days

Study Arms (2)

FFP

Patients undergoing CPB receiving FFP

no FFP

Patients undergoing CPB not receiving FFP

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients between 4 and 8 kilograms with congenital cardiac defects

You may qualify if:

  • pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass

You may not qualify if:

  • Patients requiring FFP for heparin resistance and anti-thrombin III deficiency will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

MeSH Terms

Conditions

Hemostatic DisordersHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesCardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mancho Ng, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 19, 2023

Study Start

August 28, 2023

Primary Completion

July 8, 2024

Study Completion

July 8, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

CA(1)