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NCT Number: NCT06434207

Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis

Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery. The molecular mechanisms that are responsible for the clotting profile predisposing children to blood clots in the early stages of life are currently not well described.

The goal of this proposal is to prospectively collect plasma samples from ten (10) neonates with antenatal diagnosis of severe congenital heart disease (CHD) to better understand mechanisms responsible for abnormal clotting in the perioperative period.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Embolism and Thrombosis Heart Defects, Congenital Heart Diseases Single-ventricle Thrombosis Univentricular Heart Vascular Diseases

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life

Exclusion criteria

  • None

Treatment and study plan

Collecting discarded blood samples

Other

Discarded blood samples will be collected from routine clinical labs collected before and after surgery.

Primary outcomes

  1. Characterization of microRNA in whole blood samples from neonates

    Time frame: 2 days

    isolation, purification and sequencing of patterns of miRNA and clustering analysis will be performed to determine predominant populations of miRNA related to inflammation, complement activation, and coagulation among other pathways

Study contacts

Contact information is provided by the study sponsor or research team.

Hanna Van Pelt, BS

CONTACT

[email protected]

Rachel Bernier, MPH

CONTACT

[email protected]

857-218-5348

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Acronym: EVmiRNA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 30, 2024
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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