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

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01443273
• Other study ID #: 0041-11-EMC
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Premature
• Thrombosis

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