MedDataX Logo

Sickle Cell Disease: A Retrospective Chart Review

NCT ID: NCT01441375

Last Updated: 2012-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

261 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sickle Cell Anemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Sickle cell anemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sickle cell patients non-transfused

No interventions assigned to this group

Sickle cell patients transfused with no ICT

No interventions assigned to this group

Sickle cell patients transfused with ICT

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tulane University

New Orleans, Louisiana, United States

Site Status

Universit of Tennessee

Memphis, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CICL670A2418

Identifier Type: -

Identifier Source: org_study_id