Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-31 @ 2:43 PM
Study NCT ID:
NCT02691650
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2016-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point of Care Testing of Cholinesterase Activity During Burn- and Polytrauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D002056', 'term': 'Burns'}, {'id': 'C537417', 'term': 'Butyrylcholinesterase deficiency'}, {'id': 'D009104', 'term': 'Multiple Trauma'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "A miniature amount (10 μl) of whole blood is needed for the serum cholinesterase activity analysis. This blood specimen will be taken from otherwise routine blood gas analysis collection, taken upon arrival into the emergency room, as a part of the standardized ICU diagnostic and therapeutic procedure. The serum cholinesterase activity analysis, therefore, doesn't require additional blood collection."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2016-02-16', 'studyFirstSubmitQcDate': '2016-02-20', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early diagnosis of the systemic inflammation by using the serum cholinesterase activity measurement', 'timeFrame': 'after completed patient recruitment, 1 year', 'description': 'By using Point-of-care measurement of serum cholinesterase activity (U/l) and by observing a change in the enzyme activity over time (reduction of serum cholinesterase activity within the first 6 hours after traumatic injury) would allow an additional tool in early diagnosis and treatment of systemic inflammation.'}], 'secondaryOutcomes': [{'measure': 'correlation of the cholinesterase activity and the trauma/disease severity scores', 'timeFrame': 'after completed patient recruitment, 1 year', 'description': 'To evaluate the correlation of the serum cholinesterase activity change with the trauma severity, the obtained serum cholinesterase activities (U/l) will be compared to the trauma severity scores (ISS, %TBSA).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['serum cholinesterase', 'plasma cholinesterase', 'pseudocholinesterase', 'systemic inflammation', 'SIRS', 'polytrauma'], 'conditions': ['Trauma', 'Burns']}, 'descriptionModule': {'briefSummary': 'Goal of this study is to measure serum cholinesterase activity in patients with traumatic and/or burns injury admitted to the emergency room by using point-of- care-test system (POCT). Serum cholinesterase activity, measured using POCT system, might play an important role in the early diagnosis and prediction of patient outcome in trauma-induced systemic inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the emergency unit of the trauma and burns center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed written consent\n* 18 years and older\n* severe trauma (ISS \\> 15)\n* burns injury (2. degree more than 15% body surface or 3 degree more than 10% body surface)\n* SIRS\n\nExclusion Criteria:\n\n* not fulfilling the inclusion criteria\n* failure to adhere'}, 'identificationModule': {'nctId': 'NCT02691650', 'acronym': 'POCCET', 'briefTitle': 'Point of Care Testing of Cholinesterase Activity During Burn- and Polytrauma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Point of Care Testing of Cholinesterase Activity During Burn- and Polytrauma', 'orgStudyIdInfo': {'id': 'Burns and Trauma POC ChE Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'polytrauma patients', 'description': 'Patients with severe traumatic injury, admitted to the emergency unit. Serum cholinesterase activity measurement using 10 µl whole blood, otherwise obtained through routine blood gas analysis upon arrival to the hospital.'}, {'label': 'burns patients', 'description': 'Patients with burns trauma, admitted to the emergency unit. Serum cholinesterase activity measurement using 10 µl whole blood, otherwise obtained through routine blood gas analysis upon arrival to the hospital.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67071', 'city': 'Ludwigshafen am Rhein', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Center Ludwigshafen', 'geoPoint': {'lat': 49.48121, 'lon': 8.44641}}], 'overallOfficials': [{'name': 'Stefan Hofer, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Heidelberg University Hospital'}, {'name': 'Stefan Kleinschmidt, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Centre Ludwigshafen, Ludwigshafen, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'BG Trauma Center Ludwigshafen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. Aleksandar Zivkovic', 'investigatorFullName': 'Aleksandar Zivkovic', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}