Viewing Study NCT02643459


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Study NCT ID: NCT02643459
Status: COMPLETED
Last Update Posted: 2021-03-09
First Post: 2015-11-13
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Risk Stratification in Acute Care: The Meaning of suPAR Measurement in Triage
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'martin.schultz@regionh.dk', 'phone': '004538683868', 'title': 'Dr. Martin Schultz', 'organization': 'Herlev Hospital, Department of Cardiology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Data on all outcomes were collected from national registries.', 'eventGroups': [{'id': 'EG000', 'title': 'Conventional', 'description': 'no suPAR measurement. Standard care.', 'otherNumAtRisk': 7901, 'deathsNumAtRisk': 7901, 'otherNumAffected': 700, 'seriousNumAtRisk': 7901, 'deathsNumAffected': 1126, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'suPAR', 'description': 'suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.', 'otherNumAtRisk': 8900, 'deathsNumAtRisk': 8900, 'otherNumAffected': 777, 'seriousNumAtRisk': 8900, 'deathsNumAffected': 1241, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'New cancer diagnosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7901, 'numEvents': 700, 'numAffected': 700}, {'groupId': 'EG001', 'numAtRisk': 8900, 'numEvents': 777, 'numAffected': 777}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7901', 'groupId': 'OG000'}, {'value': '8900', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional', 'description': 'no suPAR measurement. Standard care.'}, {'id': 'OG001', 'title': 'suPAR', 'description': 'suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.'}], 'classes': [{'categories': [{'measurements': [{'value': '1126', 'groupId': 'OG000'}, {'value': '1241', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months after the inclusions period ends mortality data will be assessed', 'description': 'Time frame starts at the beginning of the index admission, defined as first admission in the study period. Patients will be followed using central registers.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7901', 'groupId': 'OG000'}, {'value': '8900', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional', 'description': 'no suPAR measurement. Standard care.'}, {'id': 'OG001', 'title': 'suPAR', 'description': 'suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.'}], 'classes': [{'categories': [{'measurements': [{'value': '319', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 months after index admission mortality data will assessed', 'description': 'Mortality within 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Discharges From the Emergency Room Within 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7901', 'groupId': 'OG000'}, {'value': '8900', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional', 'description': 'no suPAR measurement. Standard care.'}, {'id': 'OG001', 'title': 'suPAR', 'description': 'suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR. Since suPAR is measured on all patients regardless of disease the investigators cannot define a single intervention. A possible intervention depends on the clinical situation.\n\nsuPAR measurement: The biomarker suPAR will be measured on all patients included in the study. Before the study period the doctors will receive information on suPAR. We want to study if the information provided by suPAR is useful in emergency medicine. Interventions depends on the clinical issue, as suPAR is an unspecific marker of disease. Usually a elevated suPAR level could result in more investigation e.g. diagnostic procedures or follow up, while a low suPAR could result in faster discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '3934', 'groupId': 'OG000'}, {'value': '4352', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'How many patients are discharged directly from the ED', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Admissions to the Medical Ward', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7901', 'groupId': 'OG000'}, {'value': '8900', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional', 'description': 'no suPAR measurement. Standard care.'}, {'id': 'OG001', 'title': 'suPAR', 'description': 'suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR. Since suPAR is measured on all patients regardless of disease the investigators cannot define a single intervention. A possible intervention depends on the clinical situation.\n\nsuPAR measurement: The biomarker suPAR will be measured on all patients included in the study. Before the study period the doctors will receive information on suPAR. We want to study if the information provided by suPAR is useful in emergency medicine. Interventions depends on the clinical issue, as suPAR is an unspecific marker of disease. Usually a elevated suPAR level could result in more investigation e.g. diagnostic procedures or follow up, while a low suPAR could result in faster discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '3500', 'groupId': 'OG000'}, {'value': '3738', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of Participants with Admissions to the Medical War', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With an Admission to the Intensive Care Unit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7901', 'groupId': 'OG000'}, {'value': '8900', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional', 'description': 'no suPAR measurement. Standard care.'}, {'id': 'OG001', 'title': 'suPAR', 'description': 'suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR. Since suPAR is measured on all patients regardless of disease the investigators cannot define a single intervention. A possible intervention depends on the clinical situation.\n\nsuPAR measurement: The biomarker suPAR will be measured on all patients included in the study. Before the study period the doctors will receive information on suPAR. We want to study if the information provided by suPAR is useful in emergency medicine. Interventions depends on the clinical issue, as suPAR is an unspecific marker of disease. Usually a elevated suPAR level could result in more investigation e.g. diagnostic procedures or follow up, while a low suPAR could result in faster discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '1027', 'groupId': 'OG000'}, {'value': '1157', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Number of Participants with transfer to the ICU', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With New Cancer Diagnosis in Control vs Intervention Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7901', 'groupId': 'OG000'}, {'value': '8900', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional', 'description': 'no suPAR measurement. Standard care.'}, {'id': 'OG001', 'title': 'suPAR', 'description': 'suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR. Since suPAR is measured on all patients regardless of disease the investigators cannot define a single intervention. A possible intervention depends on the clinical situation.\n\nsuPAR measurement: The biomarker suPAR will be measured on all patients included in the study. Before the study period the doctors will receive information on suPAR. We want to study if the information provided by suPAR is useful in emergency medicine. Interventions depends on the clinical issue, as suPAR is an unspecific marker of disease. Usually a elevated suPAR level could result in more investigation e.g. diagnostic procedures or follow up, while a low suPAR could result in faster discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '687', 'groupId': 'OG000'}, {'value': '917', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 months after inclusion period ends', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay During Admission.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7901', 'groupId': 'OG000'}, {'value': '8900', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional', 'description': 'no suPAR measurement. Standard care.'}, {'id': 'OG001', 'title': 'suPAR', 'description': 'suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR. Since suPAR is measured on all patients regardless of disease the investigators cannot define a single intervention. A possible intervention depends on the clinical situation.\n\nsuPAR measurement: The biomarker suPAR will be measured on all patients included in the study. Before the study period the doctors will receive information on suPAR. We want to study if the information provided by suPAR is useful in emergency medicine. Interventions depends on the clinical issue, as suPAR is an unspecific marker of disease. Usually a elevated suPAR level could result in more investigation e.g. diagnostic procedures or follow up, while a low suPAR could result in faster discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.53', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '4.39', 'spread': '8.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days', 'description': 'Length of stay in days during the admission', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Readmissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7901', 'groupId': 'OG000'}, {'value': '8900', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional', 'description': 'no suPAR measurement. Standard care.'}, {'id': 'OG001', 'title': 'suPAR', 'description': 'suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR. Since suPAR is measured on all patients regardless of disease the investigators cannot define a single intervention. A possible intervention depends on the clinical situation.\n\nsuPAR measurement: The biomarker suPAR will be measured on all patients included in the study. Before the study period the doctors will receive information on suPAR. We want to study if the information provided by suPAR is useful in emergency medicine. Interventions depends on the clinical issue, as suPAR is an unspecific marker of disease. Usually a elevated suPAR level could result in more investigation e.g. diagnostic procedures or follow up, while a low suPAR could result in faster discharge.'}], 'classes': [{'categories': [{'measurements': [{'value': '687', 'groupId': 'OG000'}, {'value': '917', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Patients will be followed using central registers. All new admissions within 90 days of the same patient is defined as readmissions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional', 'description': 'no suPAR measurement. Standard care.'}, {'id': 'FG001', 'title': 'suPAR', 'description': 'suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7901'}, {'groupId': 'FG001', 'numSubjects': '8900'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7901'}, {'groupId': 'FG001', 'numSubjects': '8900'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7901', 'groupId': 'BG000'}, {'value': '8900', 'groupId': 'BG001'}, {'value': '16801', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional', 'description': 'no suPAR measurement. Standard care.'}, {'id': 'BG001', 'title': 'suPAR', 'description': 'suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'spread': '20.7', 'groupId': 'BG000'}, {'value': '60.4', 'spread': '20.8', 'groupId': 'BG001'}, {'value': '60.6', 'spread': '20.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4175', 'groupId': 'BG000'}, {'value': '4689', 'groupId': 'BG001'}, {'value': '8864', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3726', 'groupId': 'BG000'}, {'value': '4211', 'groupId': 'BG001'}, {'value': '7937', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7901', 'groupId': 'BG000'}, {'value': '8900', 'groupId': 'BG001'}, {'value': '16801', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '7901', 'groupId': 'BG000'}, {'value': '8900', 'groupId': 'BG001'}, {'value': '16801', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-04', 'size': 580401, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-30T10:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2015-11-13', 'resultsFirstSubmitDate': '2019-02-25', 'studyFirstSubmitQcDate': '2015-12-29', 'lastUpdatePostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-16', 'studyFirstPostDateStruct': {'date': '2015-12-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All Cause Mortality', 'timeFrame': '10 months after the inclusions period ends mortality data will be assessed', 'description': 'Time frame starts at the beginning of the index admission, defined as first admission in the study period. Patients will be followed using central registers.'}], 'secondaryOutcomes': [{'measure': 'All Cause Mortality', 'timeFrame': '1 months after index admission mortality data will assessed', 'description': 'Mortality within 30 days'}, {'measure': 'Number of Discharges From the Emergency Room Within 24 Hours', 'timeFrame': '24 hours', 'description': 'How many patients are discharged directly from the ED'}, {'measure': 'Number of Admissions to the Medical Ward', 'timeFrame': '30 days', 'description': 'Number of Participants with Admissions to the Medical War'}, {'measure': 'Number of Patients With an Admission to the Intensive Care Unit', 'timeFrame': '30 days', 'description': 'Number of Participants with transfer to the ICU'}, {'measure': 'Number of Patients With New Cancer Diagnosis in Control vs Intervention Groups', 'timeFrame': '10 months after inclusion period ends'}, {'measure': 'Length of Stay During Admission.', 'timeFrame': '30 days', 'description': 'Length of stay in days during the admission'}, {'measure': 'Number of Readmissions', 'timeFrame': '90 days', 'description': 'Patients will be followed using central registers. All new admissions within 90 days of the same patient is defined as readmissions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Triage', 'Risk stratification', 'Acute care', 'suPAR'], 'conditions': ['Triage', 'Risk Stratification With Biomarker']}, 'referencesModule': {'references': [{'pmid': '31236143', 'type': 'DERIVED', 'citation': 'Schultz M, Rasmussen LJH, Hoi-Hansen T, Kjoller E, Jensen BN, Lind MN, Ravn L, Kallemose T, Lange T, Kober L, Rasmussen LS, Eugen-Olsen J, Iversen KK. Early Discharge from the Emergency Department Based on Soluble Urokinase Plasminogen Activator Receptor (suPAR) Levels: A TRIAGE III Substudy. Dis Markers. 2019 May 19;2019:3403549. doi: 10.1155/2019/3403549. eCollection 2019.'}, {'pmid': '30975178', 'type': 'DERIVED', 'citation': 'Schultz M, Rasmussen LJH, Kallemose T, Kjoller E, Lind MN, Ravn L, Lange T, Kober L, Rasmussen LS, Eugen-Olsen J, Iversen K. Availability of suPAR in emergency departments may improve risk stratification: a secondary analysis of the TRIAGE III trial. Scand J Trauma Resusc Emerg Med. 2019 Apr 11;27(1):43. doi: 10.1186/s13049-019-0621-7.'}, {'pmid': '30153859', 'type': 'DERIVED', 'citation': 'Schultz M, Rasmussen LJH, Andersen MH, Stefansson JS, Falkentoft AC, Alstrup M, Sando A, Holle SLK, Meyer J, Tornkvist PBS, Hoi-Hansen T, Kjoller E, Jensen BN, Lind M, Ravn L, Kallemose T, Lange T, Kober L, Rasmussen LS, Eugen-Olsen J, Iversen KK. Use of the prognostic biomarker suPAR in the emergency department improves risk stratification but has no effect on mortality: a cluster-randomized clinical trial (TRIAGE III). Scand J Trauma Resusc Emerg Med. 2018 Aug 28;26(1):69. doi: 10.1186/s13049-018-0539-5.'}, {'pmid': '27491822', 'type': 'DERIVED', 'citation': 'Sando A, Schultz M, Eugen-Olsen J, Rasmussen LS, Kober L, Kjoller E, Jensen BN, Ravn L, Lange T, Iversen K. Introduction of a prognostic biomarker to strengthen risk stratification of acutely admitted patients: rationale and design of the TRIAGE III cluster randomized interventional trial. Scand J Trauma Resusc Emerg Med. 2016 Aug 5;24:100. doi: 10.1186/s13049-016-0290-8.'}]}, 'descriptionModule': {'briefSummary': 'Will clinical outcome for patients be improved if triage in Acute wards and Emergency rooms is supplemented with a prognostic biomarker?', 'detailedDescription': 'In a health care system where the general population is growing, more patients are living with chronic conditions and the hospitals are reducing beds and length of stay, it is crucial to perform safe and fast risk stratification of patients presenting in the Emergency departments. Risk stratification is currently performed with a combination of measurement of the vital signs and assessment of the primary complaint. The aim of the current study is to assess whether the supplement of biomarkers can improve the risk stratification in regard to mortality, readmissions and improve overall patient flow in the Emergency departments. Soluble urokinase plasminogen activating receptor (suPAR) is the soluble form of urokinase-type plasminogen activator receptor (uPAR). uPAR is present on various immunological active cells, as well as endothelia and smooth muscle cells. It is believed that suPAR mirrors the inflammatory response in patients. Previous studies have shown a strong association with mortality and severity of disease in a broad variety of conditions (infection, hepatic-, renal-, cardiac- and lung disease) as well as a possible marker of disease development in the general population. These abilities indicate that suPAR although unspecific would be ideal to identify patients at high- and at low-risk. The aim is to target interventions and limited clinical focus where it is most beneficial. In unselected patients suPAR is one of the strongest prognostic biomarker available to date.\n\nIt is not known whether information on prognosis in the Emergency department can be used to prevent death, serious complications or reduce admissions and readmissions.\n\nThe purpose of the current study is to examine if introduction of the biomarker suPAR and education of doctors in the meaning of suPAR levels and association to disease, can reduce mortality, admissions and readmission in patients referred to the emergency rooms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting acutely to the Acute ward/Emergency department and have blood samples done which include both Hemoglobin, C reactive protein and Creatinine within 6 hours of registration within the study period. The study is carried out in 2 Hospitals in the Capital of Denmark.\n\nExclusion Criteria:\n\n* Patients presenting in Pediatric, Gynecological or Obstetric units. Patients not being examined with blood samples.'}, 'identificationModule': {'nctId': 'NCT02643459', 'acronym': 'suPAR', 'briefTitle': 'Risk Stratification in Acute Care: The Meaning of suPAR Measurement in Triage', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Introduction of Soluble Urokinase Plasminogen Activating Receptor in Acute Care as a Prognostic Biomarker to Strengthen Risk Stratification of Acutely Admitted Patients', 'orgStudyIdInfo': {'id': 'HerlevH01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional', 'description': 'no suPAR measurement. Standard care.'}, {'type': 'EXPERIMENTAL', 'label': 'suPAR', 'description': 'suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR. Since suPAR is measured on all patients regardless of disease the investigators cannot define a single intervention. A possible intervention depends on the clinical situation.', 'interventionNames': ['Behavioral: suPAR measurement']}], 'interventions': [{'name': 'suPAR measurement', 'type': 'BEHAVIORAL', 'description': 'The biomarker suPAR will be measured on all patients included in the study. Before the study period the doctors will receive information on suPAR. We want to study if the information provided by suPAR is useful in emergency medicine. Interventions depends on the clinical issue, as suPAR is an unspecific marker of disease. Usually a elevated suPAR level could result in more investigation e.g. diagnostic procedures or follow up, while a low suPAR could result in faster discharge.', 'armGroupLabels': ['suPAR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital, Department of Cardiology', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Kasper K Iversen, MD, DMSci', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Cardiology, Herlev Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, P.h.D student', 'investigatorFullName': 'Martin Schultz', 'investigatorAffiliation': 'Herlev Hospital'}}}}