Analysis Of Apheresis Platelets Stored Refrigerated In S-G04 Composite, 65% Intersol And 35% Plasma For Up To 21 Days
Posted Date: Jun 10, 2024
- Investigator: Caroline Alquist
- Specialties:
- Type of Study: Drug
This is a pilot, open-arm study that will compare long-term stored (up to 21 days) S-G04-containing cold-stored PLTs (Test) to 7-day room-temperature PLTs (Control) and determine their in vitro quality data (Table 1). The Test PLT products will be labeled to indicate investigational use and will be stored at 1-6ºC with agitation for up to 21 days. The Control arm will also be labeled to indicate investigational use and will be stored at 18-22ºC with agitation for 7 days. No concurrent collection of plasma or RBCs will occur from subjects in this study. Subjects will be normal research donors. RT stored PLTs will be stored per our Research Division SOPs. Cold stored PLTs will be manufactured in concordance with FDA guidance: “Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical; Guidance for Industry This is a pilot, open-arm study that will compare long-term stored (up to 21 days) S-G04-containing cold-stored PLTs (Test) to 7-day room-temperature PLTs (Control) and determine their in vitro quality data (Table 1). The Test PLT products will be labeled to indicate investigational use and will be stored at 1-6ºC with agitation for up to 21 days. The Control arm will also be labeled to indicate investigational use and will be stored at 18-22ºC with agitation for 7 days. No concurrent collection of plasma or RBCs will occur from subjects in this study. Subjects will be normal research donors. RT stored PLTs will be stored per our Research Division SOPs. Cold stored PLTs will be manufactured in concordance with FDA guidance.
Criteria:
The Study Includes Normal, Healthy Research Donors Aged 18 Years Or Older Who Are Capable And Willing To Provide Informed Consent. Additionally, Subjects Must Meet The Inclusion Criteria Established By The Study Center For Automated Blood Component Collection Systems, Which Align With Aabb Standards And Fda Regulations. Subjects Deferred From Volunteer Donations Due To Travel Restrictions Are Eligible To Participate. Moreover, Participants Must Agree To Abstain From Using Aspirin Or Aspirin-Containing Medications, Non-Steroidal Anti-Inflammatory Drugs (Nsaids), Anti-Platelet Agents, Or Other Drugs Affecting Platelet Viability Within 7 Days Prior To Apheresis, As Outlined In The Exclusion Criteria.
Keywords:
Cold Stored Platelets
For More Information:
Neeta Rugg
5136520104
neeta.rugg@uc.edu