Whole Blood Donation and Leukoreduction | Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive Solution
Whole Blood Donation and Leukoreduction research study
What is the primary objective of this study?
This study will evaluate a new blood collection and filtration system that is intended to be used to collect, filter, separate and store red blood cells and, separately, plasma. The new blood collection and filtration system will be compared to an already-approved and currently used system. Further, this study will evaluate new processing conditions relative to the individual components of the collection and filtration system. All study participants will donate two units of whole blood with individual units being donated at least 56 days apart. One unit of whole blood will be donated with the new system, and the other unit will be collected with the already-approved system. A subset of the donors (approximately 24 of the 120 participants) will have a small quantity of their red blood cells injected back into their body 42-days after they were donated in order to evaluate how well the red blood cells survive. Blood and blood products from all donors will be analyzed the day of collection and after storage (plasma after at least 30 days of storage and red blood cells after exactly 42 days of storage).
Who is eligible to participate?
Inclusion Criteria: - Age - Study donor must be ≥ 18 years of age - Weight - Study donor must be ≥ 110 pounds - Temperature - Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral) - Hemoglobin - Study donor's hemoglobin must be ≥12.5 g/dL - Hematocrit - Study donor's hematocrit must be ≥ 38%. Donor Eligibility - Study donor must meet all criteria per respective site's Research Blood Donation Record (BDR) - Prior Donation - Study donor's most recent single RBC unit donation must have been ≥56 days prior to study donation. Study donor's most recent double RBC unit donation must have been ≥ 112 days prior to study donation - Informed Consent - Study donor must have consented to study participation by reviewing and having expressed understanding the site-respective IRB-approved informed consent form prior to undergoing any study related procedures - Blood-borne Pathogens - Study donor's testing results from collected blood does not indicate a risk of transfusion-transmitted disease (TTD) - Adverse Events - Study donors must agree to report adverse events from the time of signing the informed consent to twenty-four hours following the end of their active study involvement - Pregnancy - Female study donors must not be pregnant, expected to be pregnant or breastfeeding. Only female donors who participate in the in vivo portion of the study: Women of child-bearing age must not be pregnant as determined by a negative pregnancy test prior to each re-infusion. If acceptable by local procedures, post-menopausal or surgically sterile women may be exempt from the pregnancy testing requirement Exclusion criteria: -Failure to meet one or more of the above criteria
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Whole Blood Donation and Leukoreduction
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:SOLXSOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Arm 1: Room Temperature Storage/FiltrationIn vitro whole blood storage, leukoreduction and processing of donated whole blood.
Arm 2 : Cold storageIn vitro analysis of whole blood following refrigerated storage for > 66 hours prior to leukoreduction and subsequent processing of packed red blood cells.
Start Date: April 2014
Completed Date: January 2015
Phase: Phase 1
Primary Outcome: Red Blood Cell post-filtration recovery following > 6 hours at room temperature storage (Control)
Secondary Outcome: Plasma clotting factors levels
Study sponsors, principal investigator, and references
Principal Investigator: Lou A Maes, MD
Lead Sponsor: Haemonetics Corporation