Status:
WITHDRAWN
INTERCEPT Safety Evaluation on Whole Blood
Lead Sponsor:
Swiss Transfusion SRC
Collaborating Sponsors:
Cerus Corporation
Conditions:
Safety Issues
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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,...
Detailed Description
Screening: All potentially eligible patients at the participating institution will be approached for study consent prior to study transfusion. Enrolled patients will also be asked for consent to the ...
Eligibility Criteria
Inclusion
- 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:
- 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:
- The presence of any one of the following exclusion criteria will lead to exclusion:
- 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).
- Oral, intravenous or sub-cutaneous prophylactic or therapeutic anticoagulants.
- Central body temperature increase of ≥2°C within 24 hours before transfusion.
- Clinical signs of ongoing sepsis including fever \>39°C with signs of a systemic, inflammatory response.
- Abnormal activated partial thromboplastin time (aPTT) and/or abnormal prothrombin time (PT) or INR laboratory results
- Transfusion of a blood product within 2 weeks prior to enrollment.
- Abnormal total bilirubin (≤ 2 x upper limit of normal) levels and/or clinical signs of jaundice.
- Sickle cell anemia.
- Malignant cancer patients having received chemotherapy within 12 months.
- Patients in need of multiple RBC or WB transfusions in the first 24 hours according to the investigator's judgment (i.e., more than one product).
- Pregnant or breast-feeding.
- Inability to comply with the protocol in the opinion of the investigator.
- Participation in any other type of clinical study, either concurrently or within the previous 30 days, including: investigational blood products, nutrition, pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices. Studies of psychology or socioeconomic issues are not grounds for exclusion.
- Participation on not more than two research studies per year.
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04020224
Start Date
January 1 2024
End Date
March 1 2025
Last Update
March 15 2024
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