Clinical and Laboratory Characteristics of Sickle Cell An... | NCT00736060

Studies
Clinical and Laboratory Characteristics of Sickle Cell Anemia Patients Admitted With Fever

NCT00736060

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

Aug 26, 2011Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Sickle Cell Anemia
Sickle Cell Thalassemia

Interventions

Observational

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 2011

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

May 2008

Primary Completion Date

Not provided

Completion Date

Nov 2008Actual

First Submitted Date

Aug 14, 2008

First Submission Date that Met QC Criteria

Aug 14, 2008

First Posted Date

Aug 15, 2008Estimated

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 25, 2011

Last Update Posted Date

Aug 26, 2011Estimated

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

This study will summarized the clinical and laboratory data and the outcome of all the patients suffering from Sickle Cell Anemia (Including Sickle cell thalassemia) admitted to the pediatric ward.

Detailed Description

The actual protocol for SCA patients admitted with fever is to obtain blood cultures and start empiric antibiotic treatment.

The study cohort included 60 SCA patients actually treated in the Pediatric Hematology Unit.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Sickle cell anemia	Other: Observational
2		Sickle cell thalassemia	Other: Observational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	Summary of clinical and laboratory data	1 2

Eligibility Module

Eligibility Criteria

Inclusion Criteria: All patients admitted with fever as the only presenting symptom.

Exclusion Criteria: Patients admitted with another causes related or unrelated to sickle cell disease and have also fever.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

60 patients treated at the Pediatric Hematology Unit in the Ha'Emek Medical Center suffering from sickle cell anemia or sickle cell thalassemia admitted with fever as the presenting symptom.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carina Levin, MD	Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - Israel	Principal Investigator
Ilena Arshinov, MD	Pediatric Dpt B - Ha'Emek Medical Center - Afula - Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Hematology Unit - Ha'Emek Medical Center		Afula	Afula	18101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell
D005334	Fever

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided