Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT01837758
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2013-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring Platelet Function During Continuous Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-02', 'studyFirstSubmitDate': '2013-04-16', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age', 'timeFrame': 'Baseline', 'description': 'Age of the patient at the point of enrollment'}, {'measure': 'Height', 'timeFrame': 'Baseline', 'description': 'Height of the patient measured in centimeters.'}, {'measure': 'Weight', 'timeFrame': 'Baseline', 'description': 'Weight of the patient measured in kilograms.'}, {'measure': 'Gender', 'timeFrame': 'Baseline'}, {'measure': 'ASA-Classification', 'timeFrame': 'Baseline', 'description': 'The ASA-Classification will be determined preoperatively.'}, {'measure': 'Antiaggregatory Premedication', 'timeFrame': 'Baseline', 'description': 'Antiaggregatory medication taken prior to enrollment wil be recorded in the categories aspirin, clopidogrel, ticagrelor, cumarins and others.'}, {'measure': 'Dialysis filter', 'timeFrame': 'Basline', 'description': 'The brand of filter used for the hemofiltration or hemodialysis will be registered.'}, {'measure': 'Anticoagulation for hemofiltration', 'timeFrame': 'Baseline', 'description': 'The anticoagulation used for hemofiltration will be recorded in the categories heparin and calcium citrate.'}], 'primaryOutcomes': [{'measure': 'ASPItest', 'timeFrame': 'Baseline, 6, 12, 24 and 48 hours', 'description': 'Area under the aggregation curve (AUC) after platelet stimulation with arachidonic acid at baseline and 6, 12, 24 and 48 hours after the start of the continuous hemofiltration.'}], 'secondaryOutcomes': [{'measure': 'ADPtest', 'timeFrame': 'Baseline, 6, 12, 24 and 48 hours', 'description': 'Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate at baseline and 6, 12, 24 and 48 hours after the start of the continuous hemofiltration.'}, {'measure': 'TRAPtest', 'timeFrame': 'Baseline, 6, 12, 24, 48 hours', 'description': 'Area under the aggregation curve (AUC) after platelet stimulation with thrombin-receptor-activating peptide 6 (TRAP-6) at baseline and 6, 12, 24 and 48 hours after the start of the continuous hemofiltration.'}, {'measure': 'CT-INTEM', 'timeFrame': 'Baseline, 6, 12, 24 and 48 hours', 'description': 'Clotting time (CT) in the intrinsically activated rotational thrombelastometry (ROTEM) recorded in seconds at baseline and 6, 12, 24 and 48 hours after the start of continuous veno-venous hemofiltration.'}, {'measure': 'MCF-INTEM', 'timeFrame': 'Baseline, 6, 12, 24 and 48hours', 'description': 'Maximum clot firmness (MCF) in the intrinsically activated rotational thrombelastometry (ROTEM) recorded in millimeters at baseline and 6, 12, 24 and 48 hours after the start of continuous veno-venous hemofiltration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Platelet function', 'hemofiltration', 'Multiplate'], 'conditions': ['Platelet Function']}, 'referencesModule': {'references': [{'pmid': '22592187', 'type': 'BACKGROUND', 'citation': 'Daugirdas JT, Bernardo AA. Hemodialysis effect on platelet count and function and hemodialysis-associated thrombocytopenia. Kidney Int. 2012 Jul;82(2):147-57. doi: 10.1038/ki.2012.130. Epub 2012 May 16.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study is a description of changes in platelet function during continuous veno-venous hemodialysis or hemofiltration in patients on an intensive care unit using the Multiplate system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in an intensive care unit with the need for a renal replacement therapy-', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Need for a continuous renal replacement therapy\n* Platelet Count \\>100.000/nl\n\nExclusion Criteria:\n\n* Pregnancy\n* Age \\<18 years\n* Renal replacement therapy within the 7 days prior to enrollment'}, 'identificationModule': {'nctId': 'NCT01837758', 'briefTitle': 'Monitoring Platelet Function During Continuous Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'Changes in Platelet Function During Continuous Veno-venous Hemodialysis Using the Multiplate Device', 'orgStudyIdInfo': {'id': 'CVVH-Multiplate'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dialysis', 'description': 'Platelet function will be documented during the first 48 hours of veno-venous hemofiltration using the Multiplate system.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Johann Wolfgang Goethe-University', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med Saskia Wand', 'investigatorFullName': 'Saskia Wand', 'investigatorAffiliation': 'Goethe University'}}}}