Blood Samples. Blood samples will be taken by single needle-sticks or by a tube that is left in your arm. You cannot choose how the blood is taken. There will be 6 blood draws for participants in Cohort 1; there will be about 30 blood draws for participants in Cohorts 2-6. The total amount of blood drawn will be about 90 ml (about 50 ml for first cohort) or a little over 1/3 cup. For comparison, the standard blood donation is about 480 mL (two cups). Part 2 (Cohorts 7, 8, 9, and 10):
Blood Samples. Blood samples for screening will be taken from your left or right arm using a needle and a collection vial. The total amount of blood xxxx at screening will be about 4 teaspoons (20 mL). Two teaspoons (10 mL) of blood will be collected each time a PK sample is taken at Visits 1, 2 and 3. The blood will be taken from a flexible tube called a catheter in your left or right arm. If the catheter cannot be used, blood may be drawn by needle stick. You cannot choose how the blood is taken. There will be 14 blood draws in a single dosing visit for the PK samples. The total amount of blood drawn for PK samples over the study will be about 2 cups (440 mL). For comparison, the standard blood donation is about 2 cups (480 mL). Because a catheter is being used to collect the PK blood samples, a small amount of blood will be drawn and discarded to clear the line before each PK blood draw. The amount drawn to be discarded is approximately 84 mL (about 1/3 cup).
Blood Samples. Blood samples will be obtained within one week from the catheterization procedure. Blood will be centrifugated to extract plasma and sera aliquots (for analysis of biomarkers) which will be stored in a refrigerator (-80°). Plasma and sera will be shipped to P1-CNR for analysis and final storage.
Blood Samples. Blood samples will be taken by single needle-sticks or by a tube that is left in your arm. You cannot choose how the blood is taken. There will be about 49 blood draws. The total amount of blood drawn will be about 146 mL or just over 1/2 cup. For comparison, the standard blood donation is about 480 mL (two cups).
Blood Samples. For both studies, blood was collected, handled, and stored in a manner to allow measurements of pro-/anti-oxidants, FIP, FOP, and CRP. The samples were drawn into red-coated, pre-chilled Vacutainer tubes, plunged into ice and shielded from light and immediately delivered to the laboratory where the blood was centrifuged in a refrigerated centrifuge. Plasma and serum were separated; aliquotted into O-ring-capped amber- colored cryopreservation vials; the air in the vials was displaced with inert gas (nitrogen in MAP I and argon in MAP II); and then immediately frozen at -70o C until analysis. Plasma lycopene, α-carotene, β-carotene, lutein, β-cryptoxanthin, and α-tocopherol levels from both studies were measured using high-performance liquid chromatography (HPLC) [150, 151]. The plasma free FIP were measured by a gas chromatography-mass spectrometry (GCMS) method [152] by the Molecular Epidemiology and Biomarker Research Laboratory (MEBRL) at the University of Minnesota (Minneapolis, MN). This method, considered the gold standard for the measurement of FIP, measures a well- defined set of F2-isoprostane isomers. The FIP were extracted from the participant’s sample using deuterium (4)-labeled 8-iso-prostaglandin F2 alpha as an internal standard. Unlabeled, purified F2-isoprostane was used as a calibration standard.
Blood Samples. 3.01.06.01 Effective July 1, 1993, Blood samples will be drawn and stored, to provide baseline blood testing for all represented personnel on a voluntary basis. These samples will not be tested at the time of the draw. The purpose of the blood draw is to provide a reference point for the future.
