Sickle Cell Disease: A Retrospective Chart Review

October 17, 2012 updated by: Novartis Pharmaceuticals

Complications in Patients With Sickle Cell Disease and Utilization of Iron Chelation Therapy: A Retrospective Medical Records Review

This study is a retrospective chart review of sickle cell patients and will include patients whom have received blood transfusions and those whom have not. Of the transfused patients, it will also include those whom have received chelation therapy and those whom have not.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

261

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Universit of Tennessee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Sickle cell anemia

Description

Inclusion Criteria:

  1. Patients with a diagnosis of Sickle Cell Disease (SCD) and a confirmed genotype
  2. Patients ≥ 16 years of age
  3. Patients with ≥ 6 months of follow-up data available from first SCD treatment at the center after they reach 16 years old
  4. At least one SF reading during a non-acute phase on or after the first SCD treatment at the center after they reach 16 years old

Exclusion Criteria:

  1. Patients who participated in a clinical trial for an iron chelating medication or in a clinical trial for transfusions for SCD (1) within the six months before the index date or (2) during the patient observation period
  2. Patients with sickle cell trait

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Sickle cell patients non-transfused
Sickle cell patients transfused with no ICT
Sickle cell patients transfused with ICT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sickle cell complications
Time Frame: average of 5 years
average of 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Utilization of health care delivery to treat sickle cell complications
Time Frame: average of 5 years
average of 5 years
Overall survival
Time Frame: average of 5 years
average of 5 years
Utilization of blood transfusions (patients with frequent transfusions only)
Time Frame: average of 5 years
average of 5 years
Burden of iron overload (patients with frequent transfusions only)
Time Frame: average of 5 years
average of 5 years
Utilization of Iron Chelation Therapies (ICTs) (patients receiving deferoxamine or deferasirox [Exjade®] only)
Time Frame: average of 5 years
average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

September 7, 2011

First Submitted That Met QC Criteria

September 23, 2011

First Posted (Estimate)

September 27, 2011

Study Record Updates

Last Update Posted (Estimate)

October 18, 2012

Last Update Submitted That Met QC Criteria

October 17, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CICL670A2418

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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