A Randomized, Controlled, Phase I Clinical Trial to Assess the Safety of Whole Blood Treated With Amustaline (S-303) and Glutathione (GSH), a Pathogen Reduction System in Anemic Patients.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Severe Transfusion Reactions
研究概览
简要总结
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 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 gather data to support the safety of whole blood products that underwent treatment with amustaline and glutathione and data to support a larger sufficiently powered efficacy study. This study will evaluate the safety of the system for whole blood in adult patients with anemia.
This study is designed as a randomized, controlled, open-label study. The aim is to explore the safety of the whole blood product treated with a PR system using amustaline and glutathione.
The study will enroll 20 patients with anemia. 20 patients will be randomized either to treated WB (Test) or Standard of Care, either Red Blood Cells or Whole Blood (Control).
详细描述
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 storage of their samples for a future project in TTI Project. Illiterate patients can be consented by an impartial witness.
Patients who consent to the study will be assigned a study ID number and undergo screening.
Screening data collection and procedures will include: Demographics (age, sex), vital signs, height, weight, indication for anticipated transfusion, medical history including history of bleeding and transfusion and concomitant medications. A physical examination, including skin inspection, will be performed. Blood samples will be drawn for a hematological panel (including complete blood count, blood chemistry, blood type, coagulation (aPTT, PT and/or INR) and pregnancy test (if applicable). Immunohematology tests will be performed in a patient's sample at the blood transfusion center. This includes the Direct Antibody Test (DAT), immune reactivity to RBCs that have been processed with the INTERCEPT Blood System (IBS RBC), red cell alloantibody screen (Indirect Antibody Test (IAT) / Indirect Coombs).
Blood samples (pre/post-treatment) for future research on transfusion-transmitted infections will be archived in a biobank of the Institut Pasteur de Côte d'Ivoire (IPCI)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Randomized, controlled, open-label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
- •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).
结局指标
主要结局
Severe Transfusion Reactions
时间窗: 24 hours
The primary safety outcome will be assessed by the occurrence of transfusion reactions \>= grade 2 according to the Swissmedic transfusion reaction grading and causality criteria (Appendix 1), during the first 24 hours following administration of each study transfusion, with probable, possible or certain causality to the transfused product
次要结局
- Treatment-emergent antibodies(58 (+/-7))
- Adverse events(58 (+/-7))
- Treatment-emergent auto-antibodies(58 (+/-7))
- Hemoglobin increment(24 hours)