Thrombophilic Risk Factors in Preterm and Infants Treated at Ha'Emek Medical Center Between the Years 1990 to 2010

NCT ID: NCT01443273

Last Updated: 2019-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2020-12-31

Brief Summary

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There are several factor that can be related to Neonatal Thrombotic events. Among them hypercoagulability can be the cause of those events. Factor V Leiden (FVL) and Prothrombin mutation are the most common causes of hereditary thrombophilia. The incidence of in the arab population is known to be higher than the incidence in another western populations. The purpose of this study is to review retrospectively the thrombophilic risk factors that were found in a cohort of premature babies and term newborns treated and investigated at the Neonatal Intensive Care Unit and at the Pediatric Hematology Unit.

Detailed Description

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All the demographic and clinical data will be summarized. Factors non related to the coagulation system like catheters, severe infections or congenital heart defects will be recorded. Also a full workup of prothrombotic risk factors are routinely performed in those infants. The study included basic coagulation analysis, Protein C, S and Antithrombin III activity, Activated Protein C Resistance, serum homocystein, lipoprotein (a) and Lupus Anticoagulant.

Also the three common genetic factors are analysed including Factor F Leiden (G1691A), Prothrombin Mutation (G20210A) and MTHFR polymorphism (C677T).

Conditions

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Premature Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Infants with thrombotic events

All infants (premature and term) diagnosed at the Neonatal Intensive Care Unit with thrombotic events

Medical Records study

Intervention Type OTHER

No interventions will be done related to the study besides summary of the Medical Files.

Interventions

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Medical Records study

No interventions will be done related to the study besides summary of the Medical Files.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

-All newborns (Term and Premature) diagnosed with Neonatal Thrombotic events between year 1990 to 2010.
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Dr Koren Ariel

Head of Pediatric Dpt B and Pediatric Hematology Unit and

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carina Levin, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Hematology Unit - Ha'Emek Medical Center

Locations

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Pediatric Hematology Unit - HaEmek Medical Center

Afula, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ariel Koren, MD

Role: CONTACT

972-4-6495576 ext. 5576

Facility Contacts

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Ariel Koren, MD

Role: primary

972-4-6495576 ext. 5576

Other Identifiers

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0041-11-EMC

Identifier Type: -

Identifier Source: org_study_id

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