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
1 other identifier
observational
261
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 7, 2011
CompletedFirst Posted
Study publicly available on registry
September 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedOctober 18, 2012
October 1, 2012
1 year
September 7, 2011
October 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sickle cell complications
average of 5 years
Secondary Outcomes (5)
Utilization of health care delivery to treat sickle cell complications
average of 5 years
Overall survival
average 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
Study Arms (3)
Sickle cell patients non-transfused
Sickle cell patients transfused with no ICT
Sickle cell patients transfused with ICT
Eligibility Criteria
Patients with Sickle cell anemia
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Tulane University
New Orleans, Louisiana, 70112, United States
Universit of Tennessee
Memphis, Tennessee, 38163, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2011
First Posted
September 27, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
October 18, 2012
Record last verified: 2012-10