Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-28 @ 2:51 AM
Study NCT ID:
NCT01276392
Status:
WITHDRAWN
Last Update Posted:
2015-08-20
First Post:
2011-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anticoagulation and Activation - Comparison in Continuous Renal Replacement Therapy
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'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'A main person involved left the site', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-19', 'studyFirstSubmitDate': '2011-01-12', 'studyFirstSubmitQcDate': '2011-01-12', 'lastUpdatePostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Filter life time of continuous renal replacement therapy', 'timeFrame': 'Individual time point, standardized', 'description': 'Filter life time measured in hours of duration of continuos renal replacement therapy, filter life time end, when system clotts.'}], 'secondaryOutcomes': [{'measure': 'Activation of coagulation', 'timeFrame': 'beginning of hemodialysis, 1,2,4,12,24,28,72 hours after start of hemodialysis', 'description': 'blood samples for multiplate, rotem and systemic coagulation paramters'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['regional and systemical anticoagulation', 'continuous renal replacement therapy', 'multiplate', 'rotational thrombelastometry'], 'conditions': ['Kidney Replacement Disorder']}, 'referencesModule': {'references': [{'pmid': '10850066', 'type': 'BACKGROUND', 'citation': 'Schaefer RM, Barenbrock M, Teschner M, Bahner U. [Extracorporeal renal replacement therapies in acute renal failure]. Med Klin (Munich). 2000 May 15;95(5):273-8. doi: 10.1007/pl00002121. German.'}, {'pmid': '17313917', 'type': 'BACKGROUND', 'citation': 'Toft P, Gilsaa T. [Acute renal failure in critically ill patients]. Ugeskr Laeger. 2007 Feb 19;169(8):692-5. Danish.'}, {'pmid': '9372975', 'type': 'BACKGROUND', 'citation': 'Davenport A. The coagulation system in the critically ill patient with acute renal failure and the effect of an extracorporeal circuit. Am J Kidney Dis. 1997 Nov;30(5 Suppl 4):S20-7. doi: 10.1016/s0272-6386(97)90538-2.'}, {'pmid': '17069648', 'type': 'BACKGROUND', 'citation': 'Bouman CS, de Pont AC, Meijers JC, Bakhtiari K, Roem D, Zeerleder S, Wolbink G, Korevaar JC, Levi M, de Jonge E. The effects of continuous venovenous hemofiltration on coagulation activation. Crit Care. 2006;10(5):R150. doi: 10.1186/cc5080.'}, {'pmid': '16772739', 'type': 'BACKGROUND', 'citation': 'Sabovic M, Salobir B, Preloznik Zupan I, Bratina P, Bojec V, Buturovic Ponikvar J. The influence of the haemodialysis procedure on platelets, coagulation and fibrinolysis. Pathophysiol Haemost Thromb. 2005;34(6):274-8. doi: 10.1159/000093107.'}, {'pmid': '16953288', 'type': 'BACKGROUND', 'citation': 'Lang T, von Depka M. [Possibilities and limitations of thrombelastometry/-graphy]. Hamostaseologie. 2006 Aug;26(3 Suppl 1):S20-9. German.'}]}, 'descriptionModule': {'briefSummary': 'Actual clinical practice predominantly makes use of heparin (systemically) or citrate regionally as anticoagulation in the extracorporeal circulation for renal replacement therapy. We aim to find out if different anticoagulation strategies may lead to different levels of platelet activation and whole blood coagulation. Regarding coagulation activation, it remains uncertain if there is an advantage for one of these methods. However, it is of major interest to minimize the risk of any additional clotting activation via extracorporeal circulation in these usually critically ill patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critical ill patients with acute renal failure and the need of continuous renal replacement therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years, acute renal failure with need for continuous veno-venous renal replacement therapy\n\nExclusion Criteria:\n\n* Age \\< 18 years, pregnancy, contraindications for one of the two anticoagulation methods, missing informed consent or disagreement in the progress of the study'}, 'identificationModule': {'nctId': 'NCT01276392', 'briefTitle': 'Anticoagulation and Activation - Comparison in Continuous Renal Replacement Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Platelet Function, Whole Blood Coagulation and Fibrinolysis During Continuous Renal Replacement Therapy - a Comparison of Citrate and Heparin Anticoagulation', 'orgStudyIdInfo': {'id': '01-AHTSDKM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heparin', 'description': '10 Patients undergoing continuous renal replacement therapy using heparin for providing anticoagulation. Blood samples taken at 8 predefined timepoints.'}, {'label': 'CiCa', 'description': '10 Patients undergoing continuous renal replacement therapy using citrate for providing anticoagulation. Blood samples taken at 8 predefined timepoints.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Interdisciplinary Operative Intensive Care Unit, University Hospital Duesseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Detlev Kindgen-Milles, Professor,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinik für Anästhesiologie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Leiter Interdisziplinäre Operative Intensivstation ZOM-I', 'investigatorFullName': 'Klinik für Anästhesiologie', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}