Apheresis Procedures to Obtain Plasma or Leukocytes for In Vitro Studies
Data Collection
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: March 23, 1993
Actual date on which the first participant was enrolled.In order to carry out in vitro research procedures on the plasma or leukocyte components of blood, it is often necessary to obtain larger quantities of plasma and/or leukocytes, than can be safely obtained by simple phlebotomy. These components can be easily and safely obtained using apheresis procedures in the Clinical Center Apheresis Unit. This protocol is specifically designed to conform to the requirements of the Apheresis Unit for donors to have apheresis procedures (>7 years of age and greater than or equal to 25kg). Donors must first be admitted to another approved clinical research protocol of the LPD, NIAID before they may have the apheresis procedures described in this protocol. The investigational nature of the studies in which the samples will be used, as well as the risks and benefits of the donation process will be explained to all donors, and a signed informed consent document will be obtained.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.205 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 8 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
INCLUSION CRITERIA: Enrolled on another LPD protocol. Weight greater than or equal to 25 kg Willingness to participate EXCLUSION CRITERIA: Age less than 7 years Weight less than 25 kg Cardiovascular instability Hct less than 30 Inadequate venous access PTT or PT greater than 1.5 normal Pregnancy Women who are actively breastfeeding Other condition which the attending physician or Apheresis Unit staff considers a contraindication to the procedure For Hetastarch procedure Hypertension Evidence of fluid retention
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps