Blood Sampling for Research Related to Sickle Cell Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

About this trial

This study will collect representative blood samples from healthy children and adults and from children and adults who have unique red blood cell features that are related to sickle cell disease. Sickle cell disease is a blood disease that limits the ability of red blood cells to carry oxygen throughout the body. The purpose of the study is to collect a variety of blood samples that may then be used to investigate advances and potential new drug treatments for sickle cell disease.

Volunteers must be at least 18 years of old. Samples will be taken both from healthy volunteers and from volunteers who have unique red blood cell features that are related to sickle cell disease. Candidates will be screened with a medical history.

During the study, participants will undergo a one- to two-hour outpatient procedure at the National Institutes of Health Clinical Center. Once researchers have explained the study and obtained the participant s consent, participants will donate 8 cc (approximately 2 teaspoons) of blood.

Because repeat testing helps researchers validate study findings, participants who have the unique red blood cell features mentioned above may also be asked if they are willing to return and donate another 2 cc to 8 cc of blood for additional studies. The amount of blood drawn will not exceed 50 ml with any eight-week period for adults or 7 cc within any six-week period for children.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with sickle cell trait

Patients with known hemoglobinopathies involving one or two genes for sickle hemoglobin

Healthy volunteers for control experiments

Age range: adults greater than or equal to 18 years of age

Disqualifiers

Subjects who are unable to comprehend the investigational nature of the laboratory research are ineligible to enroll in this protocol.

As a safety precaution in handling the blood samples, patients with HIV, Hepatitis B or Hepatitis C will be excluded from the study. HIV, Hepatitis B or Hepatitits C testing will not be done under this study. Participants must be co-enrolled under another NIH protocol where the screening evaluation has been performed.

Trial population

primary clinical

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 2 trial groups
Group A: Healthy Volunteers
Group B: Sickle Cell Trait

Trial outcomes

Primary outcomes

1

To screen large compound libraries for anti-sickling activity, particularly compounds that are already FDA-approved drugs, with the goal of discovering a drug for treating sickle cell disease.

To identify by high sensitivity in vitro screening methods additional compounds that inhibit sickling

Time frame
daily

Secondary outcomes

Other outcomes

Sponsors and contacts

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