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

NCT06434207 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2026-02-23

No results posted yet for this study

Summary

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.

Conditions

  • Congenital Heart Disease
  • Single-ventricle
  • Thrombosis

Interventions

OTHER

Collecting discarded blood samples

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

Sponsors & Collaborators

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06434207 on ClinicalTrials.gov