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

• Conditions: Premature; Thrombosis
• Interventions: Other: Medical Records study

• Registration Number: NCT01443273
• Lead Sponsor: HaEmek Medical Center, Israel

Brief 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.

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 Timeline

• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-29
• Study Start: 2011-10
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants with thrombotic events	Medical Records study	All infants (premature and term) diagnosed at the Neonatal Intensive Care Unit with thrombotic events

Primary Outcome Measures

Name	Time	Method
The frequency of thrombophilic risk factors in preterms and infants	One year	Recruitment of all premature and term infants born at Emek Medical Center and suffer from thrombotic events.

Trial Locations

Locations (1)

Pediatric Hematology Unit - HaEmek Medical Center; 🇮🇱 Afula, Israel