Natural History of Sickle Cell Disease
ConditionPain Crisis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-90
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
About this trial
This study is not a treatment protocol and no experimental treatments are involved. Study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated. Subjects will receive their general medical care outside the NIH and will be seen at our clinic or at CNHS with varying frequency. Subjects may be seen for multiple visits. Subjects may be asked to return for additional testing as needed. Clinical care for patients with sickle cell disease will be provided as appropriate through the Sickle Cell Clinic and the inpatient clinical center.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals with known or suspected sickle cell disease
2 years of age and older
Willing to provide informed consent or appropriate informed consent from parent or legal guardian
Patients seen at sickle outpatient clinics at any one of the participating centers (CNHS or NIH).
Disqualifiers
Patient and/or guardian unable and unwilling to give informed consent or assent.
Patients less than 2 years of age.
Trial population
The study will be open to all eligible subjects based on inclusion and exclusion criteria and who provide informed consent. Patients may self-refer, be recruited through the NIH office of recruitment, and may include patients participating on other NIH IRB approved protocols. The study will also be open to all eligible pediatric patients receiving medical care for SCD at Children s National.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,500 Participants
are grouped into 1 trial groupGroup A: Patients
Trial outcomes
Primary outcomes
1
To gather, through clinical experience, information regarding the natural history, co-morbid conditions and outcomes, and complications relating to sickle cell disease and other hemolytic disorders in minority/ethnic patients
Better characterization of the natural history of sickle cell disease
Time frame
ongoingSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov