Optimization of Biotinylation Protocol for Studies of Red Blood Cell Survival and Function After Transfusion

Completed · Early Phase 1

Conditions studied: Measuring Red Blood Cell Survival After Transfusion

In brief

The goal of this clinical trial is to compare two methods of labeling red blood cells with biotin. The main question to answer is whether red blood cells labeled 48 hours before transfusion survive as long as red blood cells labeled 6 hours before transfusion. Secondary questions are to measure the quality of the red blood cells and whether or not the biotin-labeled red blood cells induce antibodies in transfusion recipients. This study participant will have six study visits: 1. Screening visit, collect 35 ml blood, about 3 tablespoons 2. Donate 500 ml blood 3. Receive 20 ml of biotin labeled blood transfusion, collect 40 ml blood, about 3 tablespoons 4. Return 1 day after transfusion for blood draw (25 ml, about 2 tablespoons) 5. Return 30 days after transfusion for blood draw (25 ml, about 2 tablespoons) 6. Return 90 days after transfusion for blood draw (25 ml, about 2 tablespoons)

Key facts

Study ID

NCT06788080

Run by

Vitalant Research Institute

People needed

12

Starts

2024-03-07

Expected to finish

2024-11-04

Last updated by the study team

2025-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 years or older;
• Self-report that he or she feels well and healthy;
• Be able and willing to provide written informed consent;
• Be available for the duration of the trial (up to 28 weeks) and able to come to the treatment clinic for scheduled trial visits. This includes screening up to a month before blood donation, a blood donation, BioRBC transfusion (37-42 days after blood donation), and follow up visits 24h, 30 and 90 days after transfusion.
• Females should either be surgically sterile (hysterectomy or tubal ligation) or should use a highly effective, medically accepted contraceptive regimen. Highly effective methods of birth control are defined as those that result in a lower failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, condoms with spermicide, or vasectomized partner.
• All females must have a negative pregnancy test prior to enrollment. Post-menopausal females (women over 50 years of age who, in the absence of pregnancy, have a minimum of 2 months without menses) and females who have had a hysterectomy or oophorectomy will not be tested; and
• Understand the English language.

You may not qualify if…

• Other previously diagnosed RBC disorders (sickle cell disease, thalassemia, spherocytosis, hemoglobin variants);
• Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational process administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the individual inappropriate for entry into this study or would prevent completion of the study;
• Participation in another research study with an investigational drug within four weeks prior to or during the planned study duration;
• Positive screen for anti-BioRBC antibodies detectable using ID-MTS Gel Cards (Ortho Clinical Diagnostics);
• Known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/metabolic, autoimmune or pulmonary disease, or untreated hypertension;
• Cancer of any kind (except basal cell) under treatment;
• Known or past coagulopathy conditions;
• Any medical conditions or medications on the AABB medical deferral list;
• Known HIV or acquired immunodeficiency syndrome-related illness or received a positive test result for HIV infection;
• Positive test for hepatitis B virus, hepatitis C virus, human T-cell lymphotropic virus (HTLV), West Nile virus, or syphilis;
• History of significant treated or untreated mental health issues;
• Female subject who is pregnant, lactating, or with a positive pregnancy test;
• Currently taking an antibiotic or another medication for an infection;
• Known intolerance to any components (biotin) in the investigational drug formulation;
• Systolic blood pressure > 140 mm Hg;
• Diastolic blood pressure > 90 mm Hg;
• Temperature > 100°F;
• Known hemoglobin <13 for male donors and <12.5 for female donors;
• Positive direct antiglobulin test (DAT);
• Treatment with any investigational agent within 1 month before treatment infusion for this trial;
• Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule;
• Other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment;
• Institutionalized because of legal or regulatory order

Where it is running

• Anschutz Medical Center — Aurora, Colorado, United States
• Vitalant Research Institute — Denver, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.