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Sickle Cell Disease: A Retrospective Chart Review

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01441375
Enrollment
261
Registered
2011-09-27
Start date
2011-07-31
Completion date
2012-07-31
Last updated
2012-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Anemia

Keywords

Sickle cell anemia

Brief summary

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.

Interventions

None listed

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frame
Sickle cell complicationsaverage of 5 years

Secondary

MeasureTime frame
Utilization of health care delivery to treat sickle cell complicationsaverage of 5 years
Overall survivalaverage of 5 years
Utilization of blood transfusions (patients with frequent transfusions only)average of 5 years
Burden of iron overload (patients with frequent transfusions only)average of 5 years
Utilization of Iron Chelation Therapies (ICTs) (patients receiving deferoxamine or deferasirox [Exjade®] only)average of 5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026