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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00015639
Other study ID # 010156
Secondary ID 01-CC-0156
Status Completed
Phase N/A
First received April 25, 2001
Last updated March 3, 2008
Start date April 2001
Est. completion date February 2004

Study information

Verified date February 2004
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

Plasma histidine-rich glycoprotein (HRG) binds to platelets in the presence of zinc (1). This binding is totally blocked by a monoclonal antibody directed against platelet membrane CD36. Therefore, CD36 is assumed to carry the platelet binding site for HRG (2). Because CD36 also has a variety of other ligands, including polyanionic lipids, it is also possible that it contains the binding site for heparin (also polyanionic) and might be involve in the pathogenesis of heparin-induced thrombocytopenia. Demonstrating absent HRG or heparin binding to platelets lacking CD36 would confirm that the binding sites for either or both of these ligands are located on this membrane protein. Because 3% to 11% of healthy Japanese are reported to lack CD36 on their platelets, this population is a practical source of cells for examining the physiologic role(s) for CD36. Therefore, we will recruit blood donors from the Japanese community on the NIH campus. Their platelets will tested for the presence of CD36. Recruitment will be closed after two individuals have been identified whose platelets lack CD36 and who are willing to donate 30 cc of blood on 4 or 5 subsequent occasions for binding studies with radiolabeled HRG and heparin.


Description:

Plasma histidine-rich glycoprotein (HRG) binds to platelets in the presence of zinc (1). This binding is totally blocked by a monoclonal antibody directed against platelet membrane CD36. Therefore, CD36 is assumed to carry the platelet binding site for HRG (2). Because CD36 also has a variety of other ligands, including polyanionic lipids, it is also possible that it contains the binding site for heparin (also polyanionic) and might be involved in the pathogenesis of heparin-induced thrombocytopenia. Demonstrating absent HRG or heparin binding to platelets lacking CD36 would confirm that the binding sites for either or both of these ligands are located on this membrane protein. Because 3% to 11% of healthy Japanese are reported to lack CD36 on their platelets, this population is a practical source of cells for examining the physiologic role(s) for CD36. It has also been reported that 2.4% of African Americans and 4% of Taiwanese lack this protein on their platelets. Therefore, we will recruit blood donors from the Japanese, African American, and Taiwanese community on the NIH campus. Their platelets will be tested for the presence of CD36. Recruitment will be closed after two individuals have been identified whose platelets lack CD36 and who are willing to donate 30 cc of blood on 4 or 5 subsequent occasions for binding studies with radiolabeled HRG and heparin.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date February 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility INCLUSION CRITERIA:

Phase I:

Full Japanese, African American, and Taiwanese ancestry

At least 18 years of age.

Willingness and ability to participate in Phase II of the study.

Must be able to provide written informed consent.

Phase II:

Less than 1% CD36 present on platelets, compared with controls.

EXCLUSION CRITERIA:

Phase I:

A history of anemia or thrombocytopenia.

Unwillingness or inability to participate in Phase II of the study.

Phase II:

Discovery of anemia (hemoglobin less than 11.1 g/dL for women, less than 12.7 for men) or thrombocytopenia (less than 162,000/microliter for women, less than 154,000/microliter for men) in the blood counts performed during Phase I.

Subjects will not be excluded because of any medications.

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
United States Warren G. Magnuson Clinical Center (CC) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Greenwalt DE, Lipsky RH, Ockenhouse CF, Ikeda H, Tandon NN, Jamieson GA. Membrane glycoprotein CD36: a review of its roles in adherence, signal transduction, and transfusion medicine. Blood. 1992 Sep 1;80(5):1105-15. Review. — View Citation

Horne MK 3rd. Heparin binding to normal and abnormal platelets. Thromb Res. 1988 Jul 15;51(2):135-44. — View Citation

Rigotti A, Acton SL, Krieger M. The class B scavenger receptors SR-BI and CD36 are receptors for anionic phospholipids. J Biol Chem. 1995 Jul 7;270(27):16221-4. — View Citation

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