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

October 30, 2019 updated by: Dr Koren Ariel, HaEmek Medical Center, Israel
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Afula, Israel, 18101
        • Recruiting
        • Pediatric Hematology Unit - HaEmek Medical Center
        • Contact:
        • Principal Investigator:
          • Ariel Koren, MD
        • Principal Investigator:
          • Carina Levin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infants with thrombotic events
All infants (premature and term) diagnosed at the Neonatal Intensive Care Unit with thrombotic events
Other: Medical Records study
No interventions will be done related to the study besides summary of the Medical Files.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency of thrombophilic risk factors in preterms and infants
Time Frame: One year
Recruitment of all premature and term infants born at Emek Medical Center and suffer from thrombotic events.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 29, 2011

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0041-11-EMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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