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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01443273
Other study ID # 0041-11-EMC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2011
Est. completion date December 31, 2020

Study information

Verified date October 2019
Source HaEmek Medical Center, Israel
Contact Ariel Koren, MD
Phone 972-4-6495576
Email koren_a@clalit.org.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility Inclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Pediatric Hematology Unit - HaEmek Medical Center Afula

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary The frequency of thrombophilic risk factors in preterms and infants Recruitment of all premature and term infants born at Emek Medical Center and suffer from thrombotic events. One year
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