Demographic, Clinical and Laboratory Characteristics of C... | NCT00971984

Studies
Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia in Northern Israel

NCT00971984

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

Sep 1, 2015Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Thalassemia Alpha
Hemolytic Anemia

Interventions

Medical records summary

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Sep 3, 2009

First Submission Date that Met QC Criteria

Sep 3, 2009

First Posted Date

Sep 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2015

Last Update Posted Date

Sep 1, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, IsraelPrincipal Investigator

Lead Sponsor

HaEmek Medical Center, IsraelOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study intends to summarize the clinical and laboratory characteristics of children with hemolytic anemia diagnosed as having alpha thalassemia mutations.

Detailed Description

Fifty children and adolescents diagnosed as having alpha thalassemia will be studied, the clinical characteristics and hematology analysis will be summarized.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alpha thalassemia patients		Patients diagnosed with alpha thalassemia mutations and anemia	Other: Medical records summary

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical records summary	Other	Summary of Medical files and laboratory results.	Alpha thalassemia patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of the Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia	Analysis of the Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia	One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All the patients that were studied at the pediatric hematology unit ant the Ha'Emek Medical Center

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

A group of 50 children that underwent workup due to hemolytic anemia and were further diagnosis as suffering from clinical alpha thalassemia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center		Afula		18101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D017085	alpha-Thalassemia
D000743	Anemia, Hemolytic

Ancestor Terms

ID	Term
D013789	Thalassemia
D000745	Anemia, Hemolytic, Congenital
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided