Clinical Research Directory

Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use

Background: Many different research projects need a steady supply of human blood. Blood donated by screened, healthy people may be used to test new drugs, for example, or to learn how blood cells work. Scientists from the National Institutes of Health and the Food and Drug Administration want to collect blood from donors for use in laboratory studies. Objective: To collect blood and blood parts from healthy donors for research. Eligibility: Healthy people aged 18 years and older who weigh more than 110 pounds. They must meet the requirements to donate blood for research. Participants will be screened. A nurse will check their general health. The veins in both arms will be checked to make sure they are good for donation. Participants may donate whole blood as often as they wish, but no more than 2 cups will be taken over an 8-week period. At each visit, they will fill out a questionnaire about their health, and a small sample of blood will be tested to make sure it is safe to donate. Participants may also opt to donate only white blood cells. They will undergo leukapheresis: Blood will be taken from the body through a needle inserted into a vein. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a different needle. Those who donate white blood cells called granulocytes may need to take 2 drugs, including a steroid, the day before. Participants who repeat this donation will need an eye exam. Participants may remain in the study for 20 years.

COLLECT BLOOD/RESEARCH USE

This protocol is designed to provide a mechanism for the Department of Transfusion Medicine, Clinical Center to collect and process blood components from paid, healthy volunteer donors for distribution to NIH intramural investigators and FDA researchers for in vitro laboratory use. Donors meeting research donor eligibility criteria will be recruited to donate blood and blood components by standard phlebotomy and apheresis techniques. The investigational nature of the studies in which their blood will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donation. NIH and FDA investigators requesting blood components for research use will be required to submit an electronic (Web-based) memo of request, briefly describing the nature of the research, and providing assurance that samples provided through this protocol will be used solely for in vitro and not for in vivo research. This protocol also provides a detailed schema for careful and frequent laboratory safety monitoring of repeat research apheresis donors. Blood components for research use will be distributed with a unique product number, and the DTM principal and associate investigators will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the blood and components collected in this study will be used is not the subject of this protocol, and is not possible to describe, since it involves basic investigative efforts in greater than 170 different NIH and FDA laboratories. The intent of this protocol is not to approve the research itself, but to provide adequate and complete informed consent for the donor, and to assure that the education, counseling, and protection of the study subjects (research blood donors) is performed in accordance with IRB, OHSR, OPRR and other applicable Federal regulatory standards

Reticulocyte Hemoglobin Equivalent (RET-He) in Early Detection of Iron Deficiency Among Blood Donors and Its Potential Impact on Donor Eligibility and Transfusion Safety

Blood donation is essential for healthcare, but repeated whole-blood donation can deplete the body's iron stores. Standard pre-donation screening relies on hemoglobin levels to ensure donor safety; however, a drop in hemoglobin is a late sign of iron deficiency. Consequently, donors with subclinical or latent iron depletion often pass standard pre-donation screening unnoticed. The primary purpose of this study is to evaluate the clinical utility of Reticulocyte Hemoglobin Equivalent (RET-He) as an early laboratory marker for detecting iron deficiency among accepted blood donors. Because reticulocytes are newly formed red blood cells, RET-He reflects iron availability for hemoglobin production over the preceding few days, potentially detecting iron limitation much earlier than mature red blood cell indices or standard hemoglobin testing. In this prospective observational study, approximately 300 eligible voluntary blood donors aged 18 to 60 years will be enrolled at the Main Blood Bank of Assiut University Hospitals. At the time of routine donation, blood samples will be analyzed for complete blood count (CBC) with RET-He, serum ferritin, iron profile (serum iron, total iron-binding capacity, and transferrin saturation), and C-reactive protein (CRP) to control for inflammation. Participants will also be reassessed at their subsequent regular donation visit (after 90 days for males and 120 days for females) to evaluate changes in iron indices over time and explore whether adding RET-He improves donor eligibility assessment and long-term donor health.

grouP O wholE blooD : storagE leSion impacT And infLammation

"Etablissement Français du Sang" (EFS) prepares labile blood products from blood donations that are separated by type (red blood cells, plasma and platelets). The "Centre de Transfusion Sanguine des Armées" (CTSA) produces an innovative labile blood product, LTO-WB, corresponding to group O leukocyte-free whole blood. The objective of the PEDESTAL EFS study is to compare the inflammatory and biological characteristics of blood products prepared by the EFS vs. the labile blood product prepared by the CTSA.

Anti-phospolipid Antibodies in Lyme Borreliosis

Background Lyme borreliosis, caused by Borrelia burgdorferi sensu lato is transmitted to humans through the bite of an infected Ixodes tick. B. burgdorferi sensu lato accumulates intact phospholipids from its environment to support its growth. Several of these environmentally acquired phospholipids including phosphatidylserine, phosphatidylcholine and phosphatidic acid may be recognized by anti-phospholipid antibodies that are believed to arose early in infection. Here we aimed to investigate the levels of anti-phospholipid antibodies in patients with Lyme borreliosis. Methods Participants included in the study: * 150 patients with well-defined Lyme borreliosis, of which 30 presented with solitary erythema migrans (EM), 30 with multiple EM (MEM), 30 with Lyme neuroborreliosis (LNB), 30 with Lyme arthritis (LA), 30 with acrodermatitis chronica atrophicans (ACA); * 50 patients with nonspecific symptoms and positive borrelial antibodies in serum; and * 40 healthy blood donors (control group; samples from healthy blood donors were used to determine the threshold for the assays). Specimens: * 4 serum samples from each individual patient with well-defined Lyme borreliosis (1 before antibiotic treatment, 3 during follow-up up to 1 year); * 2 serum samples from patients with nonspecific symptoms and positive borrelial antibodies (1 before antibiotic treatment and one 3 months later); * healthy blood donors: 1 serum specimen. Anti-phospolipid antibodies: Levels of IgG and IgM isotypes of 4 anti-phospholipid antibodies including anti-cardiolipin (aCL), anti-phosphatidylserine (aPS), anti-phosphatidic acid (aPA) and anti-phosphatidylcholine (aPC) will be analyzed with in-house ELISAs.