Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-28 @ 5:17 PM
Study NCT ID:
NCT05367466
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2022-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors of Neonatal Thrombosis
Sponsor:
Kırıkkale University
Organization:
Study Overview
Official Title:
Evaluation of Acquired and Hereditary Risk Factors of Neonatal Thrombosis: Single-centre Experience
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The incidence of symptomatic thrombosis is between 2.4 and 6.8 per 1000 neonatal intensive care unit admission while it is 5.1 per 100 000 live births. Compared to adults, the anticoagulant and fibrinolytic system of newborns is significantly different.
In this study, the aim is to evaluate infants with neonatal thrombosis in our unit to characterize acquired and genetic risk factors, the laboratory work-up parameters and the diagnosis approach.
In this study, the aim is to evaluate infants with neonatal thrombosis in our unit to characterize acquired and genetic risk factors, the laboratory work-up parameters and the diagnosis approach.
Detailed Description:
All newborn patients diagnosed with neonatal thrombosis in our NICU between 2014 and 2019; were included in the study.
Patients' data: maternal and neonatal characteristics, consanguinity, need for resuscitation, Apgar scores, diagnoses, need for mechanical ventilation, sepsis, catheter placement, treatment regimens and hospital outcomes; Laboratory findings: CBC; D-dimer levels and the performed genetic test Thrombosis diagnosis was confirmed by imaging techniques such as ultrasonography (USG), echocardiography, and magnetic resonance imaging (MRI).
The genotypes: Factor V (Leiden) G1691A, prothrombin G20210A, MTHFRC677T, MTHFRA1298C, PAI-SERPINE1, Factor XIII V34L mutations
Patients' data: maternal and neonatal characteristics, consanguinity, need for resuscitation, Apgar scores, diagnoses, need for mechanical ventilation, sepsis, catheter placement, treatment regimens and hospital outcomes; Laboratory findings: CBC; D-dimer levels and the performed genetic test Thrombosis diagnosis was confirmed by imaging techniques such as ultrasonography (USG), echocardiography, and magnetic resonance imaging (MRI).
The genotypes: Factor V (Leiden) G1691A, prothrombin G20210A, MTHFRC677T, MTHFRA1298C, PAI-SERPINE1, Factor XIII V34L mutations
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: