Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-04-26 @ 12:55 AM
Study NCT ID:
NCT02682550
Status:
UNKNOWN
Last Update Posted:
2016-02-15
First Post:
2016-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Danger Response in Polytrauma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009104', 'term': 'Multiple Trauma'}, {'id': 'D012771', 'term': 'Shock, Hemorrhagic'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'EDTA-Plasma and Serum (drawn from polytrauma patients with an injury severity score ≥25)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-10', 'studyFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2016-02-10', 'lastUpdatePostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-6 (IL-6) plasma concentration', 'timeFrame': '24 hours after polytrauma', 'description': 'Interleukin-6 may indicate the extent of tissue damage and the inflammatory response after trauma'}], 'secondaryOutcomes': [{'measure': 'Multiple-Organ-Failure (MOF)', 'timeFrame': '0-28 days after trauma', 'description': 'daily "Sequential Organ Failure Assessment" score'}, {'measure': 'Sepsis', 'timeFrame': '0-28 days after trauma', 'description': 'sepsis definition daily in accordance to the "American College of Chest Physicians/Society of Critical Care Medicine" Consensus'}, {'measure': 'S100 calcium-binding protein B plasma concentration', 'timeFrame': 'within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma', 'description': 'plasma S100 calcium-binding protein B as a marker for central nervous system injury'}, {'measure': 'Creatinine plasma concentration', 'timeFrame': 'within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma', 'description': 'plasma creatinine to measure the glomerular filtration rate as a marker of renal function.'}, {'measure': 'Bilirubin plasma concentration', 'timeFrame': 'within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma', 'description': 'plasma bilirubin as a biomarker for liver failure'}, {'measure': 'Survival', 'timeFrame': '28-day survival', 'description': 'survival recorded every day: yes/no'}, {'measure': 'monomeric C-reactive protein', 'timeFrame': 'within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma', 'description': 'C-reactive protein may not only represent a biomarker of the systemic inflammatory response after trauma but also help to clear danger- and pathogen-associated molecular patterns'}, {'measure': 'pentameric C-reactive protein', 'timeFrame': 'within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma', 'description': 'C-reactive protein may not only represent a biomarker of the systemic inflammatory response after trauma but also help to clear danger- and pathogen-associated molecular patterns'}, {'measure': 'Interleukin-10', 'timeFrame': 'within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma', 'description': 'Inflammatory profiling: plasma concentrations of Interleukin-10'}, {'measure': 'Interleukin-1beta', 'timeFrame': 'within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma', 'description': 'Inflammatory profiling: plasma concentrations of Interleukin-1beta'}, {'measure': 'Complement factor C3a', 'timeFrame': 'within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma', 'description': 'Inflammatory profiling: plasma concentrations of Complement factor C3a'}, {'measure': 'Arterial partial oxygen pressure', 'timeFrame': 'daily, the first 10 days after trauma', 'description': 'Arterial partial oxygen pressure reflects lung performance'}, {'measure': 'Number of microvesicles derived from granulocytes in plasma of patients (as assessed by flow cytometry)', 'timeFrame': 'within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma', 'description': 'Microvesicles as carriers of clotting factors and inflammatory molecules may be significantly involved in the coagulatory and inflammatory response after trauma'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['polytrauma', 'hemorrhagic shock', 'sepsis', 'MODS'], 'conditions': ['Multiple Trauma']}, 'referencesModule': {'references': [{'pmid': '32983160', 'type': 'DERIVED', 'citation': 'Halbgebauer R, Karasu E, Braun CK, Palmer A, Braumuller S, Schultze A, Schafer F, Buckle S, Eigner A, Wachter U, Radermacher P, Resuello RRG, Tuplano JV, Nilsson Ekdahl K, Nilsson B, Armacki M, Kleger A, Seufferlein T, Kalbitz M, Gebhard F, Lambris JD, van Griensven M, Huber-Lang M. Thirty-Eight-Negative Kinase 1 Is a Mediator of Acute Kidney Injury in Experimental and Clinical Traumatic Hemorrhagic Shock. Front Immunol. 2020 Aug 26;11:2081. doi: 10.3389/fimmu.2020.02081. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The NTF\\_PT\\_2014 multicenter study aims to collect, store, and analyse plasma and serum from polytrauma-patients (injury severity score ≥25) and corresponding clinical data to address 1) how trauma modulates the release of danger molecules, inflammatory mediators, coagulation factors and novel biomarkers, 2) how the specific injury pattern affects the posttraumatic response and regenerative potential on an organ-, cell, and molecular level, and 3) how could a specific organ- and immune-monitoring predict the clinical outcome.', 'detailedDescription': 'Polytrauma is worldwide a major socio-economic problem. Especially the polytrauma-induced complications, such as systemic inflammatory response, sepsis, organ dysfunction remain associated with a high morbidity and mortality rate. The underlying posttraumatic pathophysiology remains poorly understood, especially since the polytrauma patients present a highly variable patient cohort with complex injury patterns, comorbidities and different therapeutic strategies.\n\nTherefore, the present "NTF\\_PT\\_2014" multicenter study of the Trauma Research Network (NTF) of the German Society for Orthopaedics and Trauma (DGOU) with its established national Polytrauma-serum-bank aims to collect, store, and analyse plasma and serum from polytrauma-patients and corresponding clinical data to address:\n\n1. how trauma modulates the release of danger molecules, inflammatory mediators, coagulation factors and novel biomarkers?\n2. how the specific injury pattern affects the posttraumatic response and regenerative potential on a organ-, cell, and molecular level?\n3. how could a specific organ- and immune-monitoring predict the clinical outcome?\n\nBlood will be drawn from anticipated 1000 patients with an injury severity score ≥ 25 at the time of hospital admission (in the emergency room), 8 h, 24h, 48, 120 h, and 240 h post injury. The biochemical and immune-monitoring data will be correlated to corresponding clinical data and data from the German Trauma Registry (TraumaRegister DGU®).\n\nBlood from age- and sex matched healthy volunteers (n=200) will serve as a control group.\n\nThe study will provide a detailed picture of the molecular danger response after multiple injury and may reveal novel therapeutic targets for posttraumatic complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'polytrauma patients age ≥ 18 ISS ≥ 25\n\nExclusion: cardiopulmonary reanimation before admission, gravidity, no chemotherapy or radiotherapy within the last 3 months, immune supressive drugs, hemodialysis, age \\< 18', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 18\n* healthy\n\nExclusion Criteria:\n\n* age \\< 18\n* gravidity'}, 'identificationModule': {'nctId': 'NCT02682550', 'acronym': 'NTF-PT', 'briefTitle': 'Danger Response in Polytrauma Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Analysis of the Danger Response After Polytrauma Based on the National Polytrauma-serum-bank of the Trauma Research Network (NTF) of the German Society for Orthopaedics and Trauma (DGOU)', 'orgStudyIdInfo': {'id': 'NTF_PT_2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ctrl', 'description': 'healthy volunteers, sex- and age matched Blood drawing at one time point: 20 ml', 'interventionNames': ['Procedure: blood drawing']}, {'label': 'PT', 'description': 'polytrauma patients fulfilling the following criteria:\n\n* injury severity score ≥25\n* age ≥ 18 Blood drawing at admission to the emergency room, 8 h, 24h, 48 h, 120 h and 240 h post trauma: 20 ml', 'interventionNames': ['Procedure: blood drawing']}], 'interventions': [{'name': 'blood drawing', 'type': 'PROCEDURE', 'description': 'blood drawing', 'armGroupLabels': ['Ctrl', 'PT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus S Huber-Lang, M.D., Prof.', 'role': 'CONTACT', 'email': 'markus.huber-lang@uniklinik-ulm.de', 'phone': '0049-731-5000', 'phoneExt': '54717'}, {'name': 'Manfred Weiss, M.D., Prof.', 'role': 'CONTACT', 'email': 'manfred.weiss@uniklinik-ulm.de', 'phone': '0049-731-5000', 'phoneExt': '60226'}, {'name': 'Mario Perl, M.D., Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ingo Marzi, M.D., Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Martijn Van Griensven, M.D., Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Roman Pfeiffer, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'centralContacts': [{'name': 'Markus S Huber-Lang, M.D., Prof.', 'role': 'CONTACT', 'email': 'markus.huber-lang@uniklinik-ulm.de', 'phone': '#49-731-5000', 'phoneExt': '54717'}, {'name': 'Manfred Weiss, M.D., Prof.', 'role': 'CONTACT', 'email': 'manfred.weiss@uniklinik-ulm.de', 'phone': '#49-731-5000', 'phoneExt': '60226'}], 'overallOfficials': [{'name': 'Markus Huber-Lang, M.D. Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Ulm, Center for Biomedical Research (ZBF)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Professor for Clinical and Experimental Trauma-Immunology', 'investigatorFullName': 'Markus Huber-Lang', 'investigatorAffiliation': 'University of Ulm'}}}}