Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-01-01 @ 10:20 AM
Study NCT ID:
NCT02238795
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2014-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sepsis-Associated Purpura Fulminans International Registry - Europe
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D055665', 'term': 'Purpura Fulminans'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'frank.brunkhorst@med.uni-jena.de', 'phone': '+49 3641 939', 'title': 'Prof. Dr. Frank M. Brunkhorst', 'phoneExt': '6687', 'organization': 'Jena University Hospital, Center for Clinical Studies'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'during hospital stay (estimated up to 3 months)', 'description': 'Adverse event related to PF treatment (reporting as per decision of the investigator)\n\n* Bleeding\n* Thrombotic events', 'eventGroups': [{'id': 'EG000', 'title': 'Purpura Fulminans', 'description': 'Patients diagnosed with Purpura fulminans in association with Sepsis; Since this was only a Registry observing Treatment of Purpra fulminans AE reporting was per decision of the investigator, focusing on\n\n* Bleeding\n* Thrombotic events', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 11, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Visual Nerve Damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during hospital stay (estimated up to 3 months)', 'description': 'All-cause in-hospital mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient had missing data concerned the primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'duration of hospital stay, up to 3 months', 'description': 'Hospital stay (in days), patients were observed through hospital stay as long as it took', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Extent and Severity of Purpura Fulminans Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Extent and severity of Purpura fulminans lesions: Number of lesions with purpura fulminans', 'unitOfMeasure': 'number of lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Total Sepsis-related Organ Failure Assessment (SOFA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '4.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 7', 'description': 'Mean total Sepsis-related organ failure assessment (SOFA) score at day 7, range 0-24 points, higher scores are worse.\n\nThe total SOFA score is the sum of the subscores of central nervous system, cardiovascular system, respiratory system, coagulation, liver and renal function. The range of all subscores is from 0 to 4, with 4 points indicating the worst outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Protein C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'until day 7', 'description': 'Administration of Protein C', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of ICU Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '34'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'during ICU stay (estimated up to 3 months)', 'description': 'Duration of hospitalization in an ICU', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Drug Reactions: Visual Nerve Damage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during hospital stay (estimated up to 3 months)', 'description': 'Adverse Drug Reaction related to specific PF treatment: Visual nerve damage', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Drug Reaction: Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during ICU stay', 'description': 'Occurence of Bleeding (Adverse drug reaction)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Drug Reaction: Thrombotic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during ICU stay', 'description': 'Occurence of thrombotic events (Adverse Drug Reaction)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Amputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during ICU stay', 'description': 'Need for amputation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vasopressor Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'during ICU stay (estimated up to 3 months)', 'description': 'Vasopressor-free days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ventilator-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'during ICU stay (estimated up to 3 months)', 'description': 'Number of ventilator-free days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Renal Replacement Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'during ICU stay (estimated up to 3 months)', 'description': 'Duration (hours) of renal replacement therapy', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Purpura Fulminans', 'description': 'Patients diagnosed with Purpura fulminans in association with sepsis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Patient without purpura fulminans', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Purpura Fulminans', 'description': 'Patients with purpura fulminans'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'spread': '22.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnic Origin', 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Asian/Pacific islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'spread': '7.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-11', 'size': 1754543, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-07T03:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2014-09-10', 'resultsFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2014-09-10', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-19', 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Vasopressor Days', 'timeFrame': 'during ICU stay (estimated up to 3 months)', 'description': 'Vasopressor-free days'}, {'measure': 'Ventilator-free Days', 'timeFrame': 'during ICU stay (estimated up to 3 months)', 'description': 'Number of ventilator-free days'}, {'measure': 'Renal Replacement Therapy', 'timeFrame': 'during ICU stay (estimated up to 3 months)', 'description': 'Duration (hours) of renal replacement therapy'}], 'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'during hospital stay (estimated up to 3 months)', 'description': 'All-cause in-hospital mortality'}], 'secondaryOutcomes': [{'measure': 'Hospital Stay', 'timeFrame': 'duration of hospital stay, up to 3 months', 'description': 'Hospital stay (in days), patients were observed through hospital stay as long as it took'}, {'measure': 'Extent and Severity of Purpura Fulminans Lesions', 'timeFrame': '7 days', 'description': 'Extent and severity of Purpura fulminans lesions: Number of lesions with purpura fulminans'}, {'measure': 'Mean Total Sepsis-related Organ Failure Assessment (SOFA) Score', 'timeFrame': 'day 7', 'description': 'Mean total Sepsis-related organ failure assessment (SOFA) score at day 7, range 0-24 points, higher scores are worse.\n\nThe total SOFA score is the sum of the subscores of central nervous system, cardiovascular system, respiratory system, coagulation, liver and renal function. The range of all subscores is from 0 to 4, with 4 points indicating the worst outcome.'}, {'measure': 'Protein C', 'timeFrame': 'until day 7', 'description': 'Administration of Protein C'}, {'measure': 'Duration of ICU Stay', 'timeFrame': 'during ICU stay (estimated up to 3 months)', 'description': 'Duration of hospitalization in an ICU'}, {'measure': 'Adverse Drug Reactions: Visual Nerve Damage', 'timeFrame': 'during hospital stay (estimated up to 3 months)', 'description': 'Adverse Drug Reaction related to specific PF treatment: Visual nerve damage'}, {'measure': 'Adverse Drug Reaction: Bleeding', 'timeFrame': 'during ICU stay', 'description': 'Occurence of Bleeding (Adverse drug reaction)'}, {'measure': 'Adverse Drug Reaction: Thrombotic Events', 'timeFrame': 'during ICU stay', 'description': 'Occurence of thrombotic events (Adverse Drug Reaction)'}, {'measure': 'Amputation', 'timeFrame': 'during ICU stay', 'description': 'Need for amputation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Purpura fulminans, Sepsis, Epidemiology, Morbidity, Therapy'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '25348051', 'type': 'BACKGROUND', 'citation': 'Brunkhorst FM, Patchev V. [Sepsis-associated Purpura Fulminans International Registry--Europe (SAPFIRE)]. Med Klin Intensivmed Notfmed. 2014 Nov;109(8):591-5. doi: 10.1007/s00063-014-0402-z. Epub 2014 Oct 29. German.'}], 'seeAlsoLinks': [{'url': 'http://www.sapfire-registry.org/', 'label': 'Registry website'}]}, 'descriptionModule': {'briefSummary': 'Sepsis-associated Purpura fulminans (SAPF) is a rare life-threatening condition. It is characterized by multiple skin lesions which rapidly progress to necrosis and gangrene. SAPF is a manifestation of widespread clot formation in small blood vessels which emerges secondarily to severe bacterial and viral infections. The clinical presentation of SAPF is dominated by symptoms of severe sepsis and multiple organ failure which are further aggravated by the massive skin lesions.\n\nAt present, there are no evidence-based guidelines for the medical management of SAPF. With numerous therapeutic approaches in use, there are no consistent comparisons of their efficacy. Altered role of causal pathogens following the introduction of meningococcal and pneumococcal prophylactic vaccines also remains to be investigated.\n\nThe goal of the registry is comprehensive collection and evaluation of information concerning the epidemiology, morbidity, therapy and outcome of SAPF.', 'detailedDescription': 'Purpura fulminans is the clinical manifestation of disseminated thrombosis in dermal and systemic microcirculation. This rare disease is frequently associated with multiple organ failure and represents a life-threatening condition with mortality exceeding 50 %. In the vast proportion of cases, the condition has been shown to emerge secondary to acquired Protein C deficiency associated with severe sepsis, mostly of meningococcal or pneumococcal origin.\n\nA consistent therapeutic approach to sepsis-associated Purpura fulminans (SAPF) has not been established yet. With exaggerated pro-coagulant activity being confirmed as the key pathogenic aspect, several treatment modalities aiming at the balance restoration in the coagulation cascade have been considered.\n\nSAPF causality might have been substantially altered in the wake of widespread meningococcal and pneumococcal vaccination. There are neither evidence-based treatment guidelines nor comparative evaluation of the efficacy of different therapeutic approaches.\n\nThe present registry aims at a) large-scale data accumulation and comprehensive evaluation of the incidence, causality and current treatment strategies of SAPF, b) comparative assessment of treatment strategies including or not including protein C supplementation c) identification of patient subgroups of particular eligibility for Protein C treatment, as judged by established criteria of disease severity assessment, d) feedback of aggregated data to registry contributors, thus permitting quality management and standard updates, e) dissemination of data evaluation summaries and recommendations for the use of Protein C formulations in clinical routine, f) elaboration of a framework for SAPF treatment recommendations and guidelines.\n\nThe registry comprises prospective, multicentric open-label data collection on the current state of incidence and management of SAPF, regardless of the etiopathogenic background. It will include comprehensive records on diagnosis, morbidity and management of SAPF, supplied in the form of electronic case report forms (eCRFs) by the participating centers over a period of three years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with sepsis-associated Purpura fulminans', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of sepsis and Purpura fulminans\n* Signed informed consent\n\nExclusion Criteria:\n\n* Premature neonates (below gestational age of 36 weeks)'}, 'identificationModule': {'nctId': 'NCT02238795', 'acronym': 'SAPFIRE', 'briefTitle': 'Sepsis-Associated Purpura Fulminans International Registry - Europe', 'organization': {'class': 'OTHER', 'fullName': 'Jena University Hospital'}, 'officialTitle': 'Sepsis-Associated Purpura Fulminans International Registry - Europe', 'orgStudyIdInfo': {'id': 'ZKSJ0065'}}, 'contactsLocationsModule': {'locations': [{'city': 'Jena', 'country': 'Germany', 'facility': 'University Hospital Jena, Klinik für Anästhesiologie und Intensivmedizin', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Jena', 'country': 'Germany', 'facility': 'University Hospital Jena, Klinik für Kinder- und Jugendmedizin', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '80337', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum der Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Frank M Brunkhorst, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Center for Clinical Studies, Jena University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jena University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}, {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, {'name': 'University Hospital of Cologne', 'class': 'OTHER'}, {'name': 'University Hospital, Essen', 'class': 'OTHER'}, {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, {'name': 'Hannover Medical School', 'class': 'OTHER'}, {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, {'name': 'Evangelisches Krankenhaus Bielefeld gGmbH', 'class': 'OTHER'}, {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}