Actively Recruiting
A Multi-Site Leukopak Repository Providing Annotated Biospecimens for Approved Investigator-Directed Biomedical Research Initiatives
Led by Sanguine Biosciences · Updated on 2024-12-06
20000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting and preserving leukopak biospecimens along with detailed medical data from up to 20,000 participants. This large, multi-center observational study aims to support biomedical research projects focused on discovering and developing new treatments, diagnostics, and preventative methods for complex and specific conditions. The collected biospecimens are not intended for transfusion but for research purposes. Participants may have up to two visits: a screening visit and an apheresis visit where blood components are collected. The biospecimens gathered through apheresis may be processed, stored frozen, or delivered unfrozen to approved researchers. All samples are anonymized before distribution. The study uses electronic or paper consent forms administered by study staff, and health data is collected by self-report and medical records. During participation, health questionnaires, physical exams, and laboratory tests including blood counts and viral screenings are performed to ensure suitability. Venous access is checked for successful collection. Researchers will measure outcomes related to leukopak collection from September 2022 to September 2024. Participant involvement includes vital sign checks, hemoglobin measurements, and ongoing safety assessments. The study continues until December 2026.
CONDITIONS
Brief Title
A Multi-Site Leukopak Repository Providing Annotated Biospecimens for Approved Investigator-Directed Biomedical Research Initiatives
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Persons aged 18 to 89 years at the date of informed consent
- Healthy enough to safely undergo the apheresis procedure
- Minimum weight of 110 pounds
- Pulse between 50 and 110 beats per minute
- Blood pressure with diastolic between 50 and 100 mmHg and systolic between 90 and 180 mmHg
- Adequate peripheral venous access as determined by apheresis staff
- Negative test results for Hepatitis B, Hepatitis C, and HIV 1-2 within 30 days unless collecting cells based on these diagnoses
- Complete blood count results within site-specific parameters within 30 days of apheresis
- Ability to understand and provide written informed consent including authorization for protected health information disclosure
You will not qualify if you...
- Persons younger than 18 years or older than 89 years at the date of informed consent
- History of medical conditions incompatible with safe apheresis as determined by medical evaluation
- Receipt of blood transfusion within 30 days before the study procedure
- Use of investigational (unapproved) drugs within 30 days before the study procedure
- Diagnosed medical conditions increasing procedure risks such as severe or untreated cardiovascular, kidney, liver, or lung diseases; bleeding disorders; chronic anemia; active systemic infection
- Use of ACE inhibitors unless safely held for 24 hours prior to apheresis
- Pregnancy
- Donated blood within the last 2 months at the time of consent
- Unable to understand study procedures or provide informed consent
- Requires a legally authorized representative for consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo apheresis to provide biospecimens which may be processed, stored, and distributed to researchers.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Sanguine Biosciences
Waltham, Massachusetts, United States, 02451
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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