Blood Sampling for Research Related to Sickle Cell Disease

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00542230
First received: October 10, 2007
Last updated: June 21, 2014
Last verified: June 2014
  Purpose

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 8 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.


Condition
Sickle Cell Trait
Sickle Cell Disease
Sickle Cell Anemia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: High Throughput Screening of Compound Libraries to Discover a Drug for the Treatment of Sickle Cell Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 24
Study Start Date: October 2007
Detailed Description:

The critical event leading to serious morbidity in sickle cell disease is the distortion (sickling) of red blood cells caused by abnormal hemoglobin. Currently, only hydroxyurea is proven to reduce sickling tendency and it is not fully effective. This protocol seeks to identify by high throughput in vitro screening methods additional compounds that inhibit sickling of red blood cells. Subjects with sickle cell trait or disease and normal volunteers will be asked to donate blood samples for studies to verify their hemoglobinopathies and then periodically donate small volume samples of fresh blood for use in ongoing high throughput screening tests to identify potentially clinically useful anti-sickling drugs.

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Patients with sickle cell trait
  • Patients with known hemoglobinopathies involving one or two genes for sickle hemoglobin
  • Healthy volunteers for control experiments
  • Women who are pregnant or breastfeeding are eligible to enroll in this protocol.
  • Age range: Minors greater than or equal to 8 years of age and adults greater than or equal to 18 years of age

EXCLUSION CRITERIA:

  • 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. Healthy volunteers will not be tested for HIV, Hepatitis B or Hepatitis C unless they are participants in another protocol(s) where the screening evaluation has been performed.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542230

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: William A Eaton, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00542230     History of Changes
Other Study ID Numbers: 080004, 08-DK-0004
Study First Received: October 10, 2007
Last Updated: June 21, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Erythrocytes
Drug Screen
Sickle Cell Trait
Sickle Cell Disease

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Sickle Cell Trait
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 28, 2014