INTERCEPT Blood System for RBCs Study in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections

Summary

Participation Requirements

Description

Stage A Eligible patients will be randomized and transfused with study RBCs (Test or Control with 1:1 ratio) according to local practices for up to 28 days of transfusion support. Following the 28-day acute transfusion support period, patients will be transfused with conventional RBC components as i...

Stage A Eligible patients will be randomized and transfused with study RBCs (Test or Control with 1:1 ratio) according to local practices for up to 28 days of transfusion support. Following the 28-day acute transfusion support period, patients will be transfused with conventional RBC components as indicated by their treating physician unless they are enrolled in the optional follow-up extension study. Non-bleeding patients at baseline requiring repeated RBC transfusion for congenital or acquired chronic anemia (e.g., sickle anemia, thalassemia, other hemoglobinopathies, myelodysplastic syndrome, aplastic anemia, chemotherapy or stem cell transplant etc.) will be eligible to participate in an extension option for up to 6 months to evaluate patients requiring repeated transfusion for chronic anemia. Subjects will receive the same study article (Test or Control RBC) as assigned in the initial 28-day study period. Following participation in the optional 6-month extended transfusion support period, patients will be transfused with conventional RBC components as indicated by their treating physician. Screening/Recruitment All potentially eligible patients at participating institutions will be approached for study consent. Subjects <18 years of age will require subject assent and parental consent. For subjects eligible for enrollment into the 6-month extension period option, consent/assent for the extension period should be obtained at initial enrollment. 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, type of scheduled surgery (if applicable), medical and surgical history, transfusion history, physical examination, comorbid conditions, concomitant medications, hematology panel (including complete blood count), blood type and Rh, Indirect Antiglobulin Test (IAT), blood chemistry, coagulation panel, Direct Antiglobulin Test (DAT), immune reactivity to IBS RBCs, pregnancy test (when applicable). Once all screening assessments are completed and eligibility is confirmed, the subject may be randomized. If results from the following assessments are available in the medical record within 30 days prior to randomization, those data may serve as the screening data and the assessments do not need to be repeated unless the subject has an RBC transfusion in the 30-day period: hematology panel (complete blood count), blood chemistry and coagulation panel blood type and Rh IAT, DAT, and immune reactivity to IBS RBCs physical examination If a RBC transfusion occurs after the study specific blood draws and assessments to determine eligibility are taken but prior to randomization, the subject may be randomized and the tests listed above should repeated prior to the first study transfusion. A pregnancy test (when applicable) must be performed within 7 days of randomization. Randomization and Blinding For Stage A, potentially eligible patients will be consented and begin screening in the study in order to be considered for randomization. An Interactive Web Response System (IWRS) will be used for electronic randomization of eligible patients. Randomization will be at a 1:1 ratio of Test: Control and stratified by site, baseline bleeding status [indication for RBC transfusion due to active bleeding (WHO Grade 3 or 4, APPENDIX 5) or for anemia without active bleeding], and non-bleeding patients' participation of the optional extension period (yes/no). Anticipated surgical bleeding and planned blood loss/replacement through red cell exchange at baseline should be included as active bleeding (Grade ?3) by definition. Randomized patients who do not receive any study RBC transfusions through 28 days after randomization will be withdrawn from the study and replaced. Additional data will not be collected for these patients. These subjects may be reassessed for eligibility and re-enrollment after withdrawal. At the end of screening, the patient's eligibility status will be entered into the electronic data capture system (EDC). If eligible, the patient will be randomized. Only appropriate blood bank staff will be able to access the treatment arm assignment. Study RBC unit labels will be indistinguishable for Test and Control products. Medical staff, and others caring for participating patients, as well as the sponsor (and delegates) will be blinded to treatment assignment. Unblinded delegates will monitor the production of the RBC components at designated blood centers. Stage B has an open-label, single-arm design, hence no randomization or blinding procedures are required Treatment Randomized patients will be transfused with Test or Control RBC components for up to 28 days in the initial acute transfusion period and for an additional 6-months if the subject is entered into the optional extension period. Subjects participating in Stage A's optional extended study will continue to receive the same study article (Test or Control RBC) as in their initial 28-day study period. An RBC transfusion episode is defined to include consecutive RBC units transfused with ?12 hours between transfusions (from the end of a prior component transfused to the start of a subsequent component transfused). A confirmed negative immune reaction to IBS RBC is required prior to the first study transfusion and at every time point a Type/Rh and Screen (IAT) is performed for a patient within the 28-day acute transfusion period or during the extension period. Compatibility for RBC antigens will be confirmed using site's SOPs prior to transfusion of study RBCs. In case of confirmed physiologically active antibodies to IBS RBC or any presumed or documented antibodies to IBS RBC that preclude further transfusion with study RBCs, patients will be withdrawn from the study treatment and supported with conventional RBC components and followed for safety. Patients with antibodies to IBS RBC will be investigated for evidence of hemolysis and continue with all planned visits and safety monitoring. Study Assessments: Monitoring and Follow-up Acute Transfusion Support Period (First study transfusion through Day 28 or death) and the optional extension period (if applicable). The acute transfusion support period will comprise 28 days from the day of the first study transfusion (Day 1) through Day 28, or death of a patient, plus an additional optional 6-month transfusion period for those patients entered into the extension period. During these periods, patients will receive as many study RBCs as deemed appropriate by the treating physician. All AEs, SAEs, TRs and unanticipated adverse device effects will be collected starting from the initiation of the first study transfusion through 28 days after the last study transfusion. The Investigators will assess each AE/SAE/TR and unanticipated adverse device effects for relation to the transfused study RBCs. Transfusion reactions will be classified by the definitions in the CDC NHSN Hemovigilance Module Surveillance Protocol (APPENDIX 1) and will be captured in the eCRF and, if in routine use, in the CDC NHSN Biovigilance Component/Hemovigilance Module (www.cdc.gov/nhsn). Most proximate vital signs in the medical record will be collected prior to and following each study transfusion. The subject's hemoglobin value will be collected from the medical record, or if not available, a study sample will be submitted for testing, prior to and following each study transfusion episode within 15 minutes to 24 hours after the end of the transfusion episode and before the next RBC transfusion. Relevant concomitant medications taken during the study and blood products transfused will be recorded with indication, total daily dose, and dates of drug administration. During the acute transfusion support period, patients will undergo the following assessments prior to each transfusion episode: vital signs, AEs, TRs, SAEs and unanticipated adverse device effects, comorbid conditions, blood samples for safety labs (complete blood count, blood chemistry panel), IAT and immune reactivity to IBS RBCs. Samples may be used for additional in vitro research tests as required to confirm transfusion-transmitted pathogen mediated infections. An immune reactivity to IBS RBCs test will be performed and resulted each time an IAT is performed within the 28-day acute and 6-month extension transfusion support period. Follow-Up Period (28 and 75 days after last study transfusion) For the purposes of the Day 28 (± 7 days) and Day 75 (± 15 days) follow-up visits, Day 1 of the follow-up period is the day after the last study transfusion, either in the initial 28 day acute transfusion period or, if the subject is entered, in the optional extension period. Day 28 (± 7 days) After the Last Study Transfusion Vital signs will be collected, and blood samples will be collected for: Routine safety labs (complete blood count, blood chemistry panel, hematology panel, and coagulation panel) DAT and IAT Immune reactivity test for IBS RBC All AEs, SAEs, TRs and unanticipated adverse device effects will be reviewed and recorded for the period from the first study transfusion through 28 days after the last study transfusion. End of Study Visit (Day 75 ±15 days) Day 75 (± 15 days) after the last study transfusion either in the initial 28 day acute transfusion period or after the extension period, a blood sample will be collected for a DAT and immune reactivity test for IBS RBC.

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