This trial is active, not recruiting.

Condition sickle cell disease
Sponsor Children's Hospital Los Angeles
Start date December 2009
End date October 2018
Trial size 150 participants
Trial identifier NCT01239901, 1RC1HL099412-01


The purpose of this research study is to determine the frequency and severity of iron overload in patients with Sickle Cell Anemia and its relationship to blood vessel function. The investigators hypothesize that intermittent transfusions that these patients receive during hospitalizations produces significant iron overload and impairs blood vessel relaxation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional

Primary Outcomes

Liver iron concentration (LIC), pancreas R2*, and kidney R2*, measured by MRI
time frame: 15 min MRI done completed during one time study visit

Secondary Outcomes

Vascular function.
time frame: Scheduled during one time study visit

Eligibility Criteria

Male or female participants at least 13 years old.

Inclusion Criteria: - Age > 13 years - Documented diagnosis of sickle cell anemia (SS, SC, Sß0, Sß+) - Transfused no more than 8 times in a year. Exclusion Criteria: - Cardiac pacemaker, implantable neurostimulator or other MRI incompatible device. - History of extreme claustrophobia in MRI machine or other reason for inability to do MRI without sedation. - Inability to be positioned on the MRI table for sufficient time to complete the MRI exams. - Any medical or psychological condition that, in the opinion of the local investigator, would make it unsafe or ill-advised for the subject to participate. - Currently not receiving chronic transfusion therapy, defined as greater than 8 transfusions per year.

Additional Information

Official title Iron-mediated Vascular Disease in Sickle Cell Disease.
Principal investigator John C Wood, MD, PhD
Description Patients with sickle cell anemia often require blood transfusion as part of the treatment for their disease. Each teaspoon of transfused blood contains about 5 mg of iron and the levels of iron in sickle cell patients increase rapidly with each transfusion. While iron is necessary for many bodily functions, too much iron damages blood vessels, liver, hormone producing glands (pancreas, pituitary and thyroid) and the heart. It is important to know how iron damages blood vessels because most of the problems experienced by sickle cell anemia patients (stroke, kidney failure, pulmonary hypertension, heart disease) result from blood vessel damage. In this trial, iron in the liver, pancreas, and kidney will be measured noninvasively by MRI while vascular function will be measured by ultrasound and tissue Doppler. Patients will be recruited primarily from the greater Los Angeles area, although patients from greater distances will be allowed to participate.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Children's Hospital Los Angeles.