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Sickle Cell Disease: A Retrospective Chart Review

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: September 7, 2011
Last updated: October 17, 2012
Last verified: October 2012
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.

Sickle Cell Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Complications in Patients With Sickle Cell Disease and Utilization of Iron Chelation Therapy: A Retrospective Medical Records Review

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Sickle cell complications [ Time Frame: average of 5 years ]

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

Enrollment: 261
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Sickle cell patients non-transfused
Sickle cell patients transfused with no ICT
Sickle cell patients transfused with ICT


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Sickle cell anemia

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01441375

United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Tennessee
Universit of Tennessee
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01441375     History of Changes
Other Study ID Numbers: CICL670A2418
Study First Received: September 7, 2011
Last Updated: October 17, 2012

Keywords provided by Novartis:
Sickle cell anemia

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn processed this record on April 28, 2017