Status:
WITHDRAWN
INTERCEPT Safety Evaluation in Anemic Patients
Lead Sponsor:
Swiss Transfusion SRC
Collaborating Sponsors:
Cerus Corporation
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The pathogen reduction (PR) system for Whole Blood (WB) using Amustaline (S-303) and Glutathione (GSH) has a potential to decrease transfusion-transmitted infection. There is scientific basis to hypot...
Detailed Description
Screening: All potentially eligible patients at the participating institution will be approached for study consent prior to study transfusion. Enrolled patients will be asked for consent to the stora...
Eligibility Criteria
Inclusion
- Stable anemic patients according to local clinical guidelines qualified to receive a whole blood transfusion in a non-emergency situation.
- Inclusion criteria:
- Patients must fulfill all of the following inclusion criteria:
- Patients must be18 years of age or older;
- Patients must have a hemoglobin level of \>/= 5.0 g/dl. Patients with hemoglobin levels of \>7.0 will not be excluded provided the patient's physician deems transfusion is needed to address anemia-induced symptoms.
- Patients must sign informed consent 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 TTI. Patients may participate in the main trial and decline collection of specimens for future research on TTI.
- 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:
- Stable anemic patients according to local clinical guidelines qualified to receive a transfusion in a non-emergency situation.
- Inclusion criteria:
- Patients must fulfill all of the following inclusion criteria:
- Patients must be18 years of age or older;
- Patients must have a hemoglobin level of \>/= 5.0 g/dl. Patients with hemoglobin levels of \>7.0 will not be excluded provided the patient's physician deems transfusion is needed to address anemia-induced symptoms.
- Patients must sign informed consent 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 TTI. Patients may participate in the main trial and decline collection of specimens for future research on TTI.
- 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 (due to concern of limited supply).
- Positive antibody screening reaction specific to red blood cells treated by 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 CTCAE v5.0.
- Lifelong history of major bleeding due to congenital or acquired coagulopathy.
- History of thrombosis or thromboembolic events.
- Blood in urine or feces 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.
- Previous treatment with other pathogen-reduced blood products.
- 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 attending physician'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: 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).
Exclusion
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03486054
Start Date
June 1 2019
End Date
June 1 2020
Last Update
December 13 2019
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