Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-25 @ 4:39 PM
Study NCT ID:
NCT02030327
Status:
UNKNOWN
Last Update Posted:
2022-05-17
First Post:
2014-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proteomics in Multiple Trauma to Identify Organ Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009104', 'term': 'Multiple Trauma'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum (blood) and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2014-01-02', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with disease or death vs. healthy', 'timeFrame': 'Day 0 until day 20', 'description': 'Starting at day O, then every 24 hours until day 20'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['proteomics', 'multiple trauma', 'organ dysfunction'], 'conditions': ['Multiple Trauma']}, 'descriptionModule': {'briefSummary': 'To analyse differences in protein expression in multiple trauma patients for identification of potential biomarkers to predict organ dysfunction.', 'detailedDescription': 'The aim of the present study in humans is to analyse differences in protein expression after multiple trauma in patients for identification of potential biomarkers to predict organ dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'older than 18 years multiple trauma patients ISS \\>16', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years\n* multiple trauma patients\n* ISS \\>16\n\nExclusion Criteria:\n\n* children\n* ISS \\<16'}, 'identificationModule': {'nctId': 'NCT02030327', 'briefTitle': 'Proteomics in Multiple Trauma to Identify Organ Failure', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Köln'}, 'officialTitle': 'Analysis of Predictive Parameters by Proteomics for Early Diagnosis of Organ Dysfunction in Multiple Trauma Patients - A Pilot Study', 'orgStudyIdInfo': {'id': '12-236'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No trauma', 'description': 'n=5 patients'}, {'label': 'trauma without organ dysfunction', 'description': 'n=40 patients'}, {'label': 'trauma with organ dysfunction', 'description': 'n=40 patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jochen Hinkelbein, MD', 'role': 'CONTACT', 'email': 'jochen.hinkelbein@uk-koeln.de', 'phone': '+49221478', 'phoneExt': '-97728'}, {'name': 'Jochen Hinkelbein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'overallOfficials': [{'name': 'Jochen Hinkelbein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UK Köln'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Köln', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Priv.-Doz. Dr. med.', 'investigatorFullName': 'Jochen Hinkelbein', 'investigatorAffiliation': 'Universitätsklinikum Köln'}}}}