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Completed

NCT Number: NCT01441375

Sickle Cell Disease: A Retrospective Chart 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.

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Key information

Conditions

Sickle Cell Anemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tulane University, New Orleans, Louisiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a diagnosis of Sickle Cell Disease (SCD) and a confirmed genotype
  • Patients ≥ 16 years of age
  • Patients with ≥ 6 months of follow-up data available from first SCD treatment at the center after they reach 16 years old
  • 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

  • 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
  • Patients with sickle cell trait

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Primary outcomes

  1. Sickle cell complications

    Time frame: average of 5 years

Secondary outcomes

  1. Utilization of health care delivery to treat sickle cell complications

    Time frame: average of 5 years

  2. Overall survival

    Time frame: average of 5 years

  3. Utilization of blood transfusions (patients with frequent transfusions only)

    Time frame: average of 5 years

  4. Burden of iron overload (patients with frequent transfusions only)

    Time frame: average of 5 years

  5. Utilization of Iron Chelation Therapies (ICTs) (patients receiving deferoxamine or deferasirox [Exjade®] only)

    Time frame: average of 5 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 27, 2011
Registry last updated
Oct 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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