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OpenTrials
Completed

NCT Number: NCT05367466

Risk Factors of Neonatal Thrombosis

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.

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Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

1 day and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

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

Inclusion criteria

  • All newborn accepted at NICU

Exclusion criteria

  • No

Treatment and study plan

Primary outcomes

  1. Thrombosis in the neonatal period is multifactorial

    Time frame: January 2022

  2. Hereditary thrombophilia factors also should be thought

    Time frame: January 2022

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study title

Evaluation of Acquired and Hereditary Risk Factors of Neonatal Thrombosis: Single-centre Experience

Important dates

Study start
2014
Primary completion
2019
Study completion
2022
First posted
May 10, 2022
Registry last updated
May 10, 2022

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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