Recruiting

Observational Study

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT00081523

Conditions

Pain Crisis

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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....

Conditions

Pain Crisis

Study ID

NCT00081523

Start date

Apr 29, 2004

Status verified date

Aug 13, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:
  • 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).

EXCLUSION CRITERIA:

  • Patient and/or guardian unable and unwilling to give informed consent or assent.
  • Patients less than 2 years of age.

Individuals with known or suspected sickle cell disease will meet the inclusion criteria to enroll in this protocol and can undergo study activities. However, if the individual is found not to have sickle cell disease after enrollment, they will be removed from the protocol, and their research samples will be discarded but they will be counted toward the study accrual. The study team will notify the individual about their removal from the study and explain the reason for it. Any necessary regulatory reporting will also be completed.

Study Design

Enrollment

3500 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients

Individuals with known or suspected sickle cell disease

Primary outcome measure

  • 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 [ Time Frame: ongoing ]

Central Contacts and Locations

Central contacts

Nancy A Asomaning

(301) 605-0398nancy.asomaning@nih.gov

Locations

Childrens National Health Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Deepika Darbari, M.D.

202-476-6393ddarbari@cnmc.org

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Sep 1, 2026

Last verified

Aug 13, 2026

Keywords

  • Hemoglobin
  • Acute Chest Syndrome
  • Treatment Options
  • Nitric Oxide
  • Pulmonary Hypertension
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-09-01.