The pathogen reduction system for whole blood using amustaline (S-303) and glutathione (GSH) hast a potential to decrease transfusion-transmitted infection. There is a scientific basis to hypothesize, that cells containing DNA and RNA such as bacteria, viruses and parasites that could be present in blood collected from asymptomatic infected donors are inactivated in the treated whole blood and therefore reduce the risk of transfusion-transmitted infections.
The aim of the study is to assess the safety of whole blood treated with amustaline and glutathione and transfused in patients with anemia.
This is a first-in-human-subjects study. Whole blood (WB) products treated with the amustaline (S-303) and glutathione (GSH) pathogen reduction technology have not been evaluated in human beings. However, red blood cells concentrates treated with amustaline and GSH have been evaluated in multiple clinical studies.
The study described in this protocol is a randomized, controlled, open-label Phase I clinical trial.
20 patients will be randomized into either the Test or Control arm in a ratio of 1:1.
10 patients assigned to the Test arm will receive one amustaline/GSH treated whole blood product.
10 patients assigned to the Control arm will receive the Standard of Care (SOC), either one red blood cell (RBC) component or one whole blood product.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must be18 years of age or older;
. Patients should have poorly tolerated anemia with a hemoglobin level greater than or equal to 5.0 g/dl and less than or equal to 7.0 g/dl. At the discretion of the investigator, inclusion is possible at a hemoglobin level greater than 7.0 g/dl if the criteria in the current local guidelines are met.
. Patients must sign the study's informed consent form prior to initiation of any study-specific procedure / treatment. Enrolled patients may give additional consent for specimens collected during this study to be used for future research on TTIs. Patients may participate in the main trial and decline collection of specimens for future research.
. Patients must agree to be hospitalized for a maximum of 72 hours after initiation of a study transfusion;
. Female patients of childbearing potential must:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. have a negative serum pregnancy test within 72 hours prior to receiving the first study blood to rule out pregnancy, and;
. use at least one method of birth control that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. These include combined oral contraceptives, implants, injectable, some intrauterine devices, sexual abstinence or vasectomized partner. The selected method must be used for the duration of study participation that means from day 1 (day of initiation of study transfusion) until day 58 (Final Study Visit).
Exclusion criteria
. Patients with blood group AB and blood group O Rhesus negative (due to concern of limited supply).
. Positive antibody screening reaction specific to red blood cells treated with amustaline and glutathione (GSH).
. Positive red cell alloantibody screening (IAT) / presence of red cell antibodies;
. Patient has ongoing clinical-significant bleeding described as grade 2 or more according to the U.S. National Cancer Institute's CTCAE v5.0 severity grading scale.
. Lifelong history of major bleeding due to congenital or acquired coagulopathy.
. History of thrombosis or thromboembolic events.
. Blood in feces or hemoglobinuria in the last 30 days.
. Pre-transfusion thrombocyte counts of \< than 50 Giga/l (x109).