Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT02305732
Status:
COMPLETED
Last Update Posted:
2018-10-30
First Post:
2014-11-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cmoore@cerus.com', 'phone': '925-288-6361', 'title': 'Carol Moore, Senior VP Regulatory Affairs & Quality', 'organization': 'Cerus'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for 24 hours following each study transfusion and serious adverse event data were collected for 7 days post each study transfusion.', 'eventGroups': [{'id': 'EG000', 'title': 'INTERCEPT', 'description': 'Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 15, 'seriousNumAtRisk': 90, 'deathsNumAffected': 17, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HIV test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatorenal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Klebsiella bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Choking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}, {'units': 'Platelet Components', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transfused INTERCEPT Components', 'description': 'Includes all INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1 year', 'description': 'INTERCEPT platelet components (PCs) manufactured for this study are leukocyte reduced apheresis PCs processed using the INTERCEPT Blood System (IBS) for platelets. The IBS for platelets is a Class III medical device approved by the FDA for the ex-vivo preparation and storage of pathogen reduced apheresis PCs. The system is used to inactivate a broad range of pathogens, including viruses, bacteria, and protozoan parasites as well as contaminating donor leukocytes. Post-manufacturing, INTERCEPT PCs are either transfused or stored according to blood center standard operating procedures, US FDA, and AABB Guidelines.\n\nSubjects enrolled in this study are transfused with INTERCEPT PCs as dictated by the treating physician. One platelet component was treated as one platelet transfusion for the purpose of data analysis in this study.', 'unitOfMeasure': 'Platelet Components', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Platelet Components', 'denomUnitsSelected': 'Platelet Components', 'populationDescription': 'This outcome summarizes the 256 INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study. A total of 90 patients received at least one INTERCEPT platelet component. "1 Transfusion = 1 Intercept Platelet Component".'}, {'type': 'PRIMARY', 'title': 'The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INTERCEPT', 'description': 'Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Proportion of Patients With Any Transfusion Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INTERCEPT', 'description': 'Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Proportion of Patients With Any Unrelated Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INTERCEPT', 'description': 'Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Proportion of Transfused INTERCEPT Platelet Components Associated With Any Transfusion Reactions and/or Unrelated Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}, {'units': 'Platelet Components', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Transfused INTERCEPT Components', 'description': 'Includes all INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1 year', 'description': 'Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.\n\nUnrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.\n\n""1 Transfusion = 1 Intercept Platelet Component".', 'unitOfMeasure': 'Platelet Components', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Platelet Components', 'denomUnitsSelected': 'Platelet Components', 'populationDescription': 'This outcome summarizes the 256 INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study. A total of 90 patients received at least one INTERCEPT platelet component.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'INTERCEPT', 'description': 'Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'INTERCEPT', 'description': 'Includes patients enrolled during the INTERCEPT-Treatment-Use phase of the study who received at least one INTERCEPT platelet component.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.2', 'spread': '15.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-24', 'studyFirstSubmitDate': '2014-11-25', 'resultsFirstSubmitDate': '2017-05-09', 'studyFirstSubmitQcDate': '2014-11-28', 'lastUpdatePostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-24', 'studyFirstPostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets.', 'timeFrame': '1 year', 'description': 'INTERCEPT platelet components (PCs) manufactured for this study are leukocyte reduced apheresis PCs processed using the INTERCEPT Blood System (IBS) for platelets. The IBS for platelets is a Class III medical device approved by the FDA for the ex-vivo preparation and storage of pathogen reduced apheresis PCs. The system is used to inactivate a broad range of pathogens, including viruses, bacteria, and protozoan parasites as well as contaminating donor leukocytes. Post-manufacturing, INTERCEPT PCs are either transfused or stored according to blood center standard operating procedures, US FDA, and AABB Guidelines.\n\nSubjects enrolled in this study are transfused with INTERCEPT PCs as dictated by the treating physician. One platelet component was treated as one platelet transfusion for the purpose of data analysis in this study.'}, {'measure': 'The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection', 'timeFrame': '1 year'}, {'measure': 'The Proportion of Patients With Any Transfusion Reactions', 'timeFrame': '1 year', 'description': 'Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.'}, {'measure': 'The Proportion of Patients With Any Unrelated Adverse Event', 'timeFrame': '1 year', 'description': 'Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.'}, {'measure': 'The Proportion of Transfused INTERCEPT Platelet Components Associated With Any Transfusion Reactions and/or Unrelated Adverse Event', 'timeFrame': '1 year', 'description': 'Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.\n\nUnrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.\n\n""1 Transfusion = 1 Intercept Platelet Component".'}]}, 'conditionsModule': {'keywords': ['Chikungunya virus', 'CHIKV', 'Dengue virus', 'DENV', 'pathogen inactivation', 'platelets', 'Puerto Rico'], 'conditions': ['Chikungunya Virus', 'Dengue Virus']}, 'descriptionModule': {'briefSummary': 'The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is to address current gaps in platelet transfusion safety in selected geographic regions. The objective is to provide access to INTERCEPT PCs for patients who might be at risk of transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus (DENV) in regions in which a substantial proportion of the population has been infected or is at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic infection among qualified blood donors is recognized (Stramer 2012, Adda 2014).\n\nThe study is designed as a prospective, open label, multi-center, observational study to evaluate the safety and efficacy of INTERCEPT platelet components.', 'detailedDescription': 'Upon written informed consent, patients will be transfused with study PCs according to local practices. Each patient will be supported with platelets as clinically indicated in a manner that is consistent with the local standard of care. The study will be conducted in two phases. During the pilot phase, patients will sign informed consent to have study data collected following transfusion with conventional PCs. The objective of the pilot phase is to evaluate study logistics and data collection methods. During the INTERCEPT Treatment Use phase, patients will sign informed consent to receive INTERCEPT PCs, provide blood samples, and collect study data (demographics, transfusion data, and safety data).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring a platelet transfusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a serious disease expected to require or requiring a transfusion of platelet component(s)\n* Patient population as defined by each Investigator and their institutional review board (IRB).\n* Patient provides written informed consent\n\nExclusion Criteria\n\n* Documented allergy to psoralens\n* Neonatal patients treated with phototherapy devices that emit wavelengths less than 425 nm due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.\n* Pregnant women in their third trimester of pregnancy (due to possibility the neonate may need bilirubin light treatment after birth).'}, 'identificationModule': {'nctId': 'NCT02305732', 'acronym': 'TRUE', 'briefTitle': 'A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cerus Corporation'}, 'officialTitle': 'A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components', 'orgStudyIdInfo': {'id': 'CLI 00108'}}, 'armsInterventionsModule': {'interventions': [{'name': 'INTERCEPT Platelets', 'type': 'BIOLOGICAL', 'description': 'INTERCEPT platelet components (PC). Leukocyte reduced apheresis platelet components collected in Platelet Additive Solution (PAS) or 100% plasma without gamma irradiation, bacterial detection, and Cytomegalovirus (CMV) serology testing.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00705', 'city': 'Aibonito', 'country': 'Puerto Rico', 'facility': 'Hospital General Menonita de Aibonito', 'geoPoint': {'lat': 18.13996, 'lon': -66.266}}, {'zip': '00725', 'city': 'Caguas', 'country': 'Puerto Rico', 'facility': 'Hospital General Menonita de Caguas', 'geoPoint': {'lat': 18.23412, 'lon': -66.0485}}, {'city': 'Cayey', 'country': 'Puerto Rico', 'facility': 'Hospital General Menonita de Cayey', 'geoPoint': {'lat': 18.11191, 'lon': -66.166}}, {'zip': '00674', 'city': 'Manatí', 'country': 'Puerto Rico', 'facility': 'Center Hospital Manati', 'geoPoint': {'lat': 18.42745, 'lon': -66.49212}}, {'zip': '00733', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Hospital San Lucas Ponce', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '00683', 'city': 'San Germán', 'country': 'Puerto Rico', 'facility': 'Hospital La Concepcion San German', 'geoPoint': {'lat': 18.08163, 'lon': -67.0449}}, {'zip': '00683', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Centro Cardiovascular de Puerto Rico and the Caribbean', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00921', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Veteran Administration', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Susan L Stramer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American National Red Cross'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cerus Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'American National Red Cross', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}