Sickle Cell Disease: A Retrospective Chart Review

Sickle Cell Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441375
• Other study ID #: CICL670A2418
• Status: Completed
• Phase: N/A
• First received: September 7, 2011
• Last updated: October 17, 2012
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Anemia

Locations

Country	Name	City	State
United States	Universit of Tennessee	Memphis	Tennessee
United States	Tulane University	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sickle cell complications		average of 5 years	Yes
Secondary	Utilization of health care delivery to treat sickle cell complications		average of 5 years	No
Secondary	Overall survival		average of 5 years	Yes
Secondary	Utilization of blood transfusions (patients with frequent transfusions only)		average of 5 years	No
Secondary	Burden of iron overload (patients with frequent transfusions only)		average of 5 years	Yes
Secondary	Utilization of Iron Chelation Therapies (ICTs) (patients receiving deferoxamine or deferasirox [Exjade®] only)		average of 5 years	No