Collection of Blood From Patients With Pancytopenia

NCT00001214 | Completed

• 2 other identifiers: 86008886-H-0088
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Aplastic anemia is a condition in which the cells normally found in blood are greatly decreased. The normal levels of white blood cells, red blood cells, and platelets are much lower in patients with aplastic anemia. Because of these low levels of blood cells, patients with aplastic anemia have a variety of immune system abnormalities. However, low levels of blood cells make it difficult to collect specialized white blood cells (mononuclear cells) for research studies. This study was designed to collect lymphocytes from patients with low levels of all blood cells (pancytopenia) for use in research. Patients participating in the study will undergo a special procedure known as lymphapheresis. During lymphapheresis blood is taken from the patient in a manner similar to blood donation. The white blood cells are selectively removed by spinning (centrifugation), and the remaining red blood cells and platelets are placed back (re-infused) into the donor s blood stream. Patients participating in this study will not benefit directly from it. However, cells collected in this study may increase scientific knowledge and improve understanding and treatment for diseases like aplastic anemia.

Conditions

Pancytopenia

Keywords

Bone Marrow Failure; Lymphocytapheresis; Pancytopenia; Aplastic Anemia; Hematosuppressive Disease

Outcome Measures

Primary Outcomes (1)

• Goal was to obtain adequate numbers of cells for laboratory studies from pancytopenic patients in whom simple phlebotomy is inadequate.

  To obtain enough cells if phlebotomy inadequate.

  1 day

Study Arms (1)

Group 1

Patients with pancytopenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pancytopenia@@@

You may qualify if:

• All patients with aplastic anemia or other bone marrow failure in which we would not expect to obtain 1 X 10(8) mononuclear cells from 100 mls of peripheral blood (i.e. an absolute lymphocyte count approximately less than 2000 per mm(3)).
• Age greater than or equal to 18.

You may not qualify if:

• Patients unable to comprehend the investigational nature of the procedure.
• Patients unable to tolerate a temporary reduction of blood volume the equivalent of one unit of blood.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Pancytopenia; Bone Marrow Failure Disorders; Anemia, Aplastic

Condition Hierarchy (Ancestors)

Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Anemia

Study Officials

• Neal S Young, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: April 30, 1986
• Primary Completion: January 19, 2009
• Study Completion: August 17, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

US (1)