Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 5:50 PM
Study NCT ID:
NCT00965328
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
2009-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079664', 'term': 'Continuous Renal Replacement Therapy'}], 'ancestors': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-24', 'studyFirstSubmitDate': '2009-08-24', 'studyFirstSubmitQcDate': '2009-08-24', 'lastUpdatePostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anticoagulation', 'hemofiltration', 'acute kidney injury', 'heparin', 'hemostasis', 'nadroparin', 'anti-Xa', 'endogenous thrombin potential'], 'conditions': ['Kidney', 'Acute Renal Failure', 'Multiple Organ Failure']}, 'referencesModule': {'references': [{'pmid': '36416787', 'type': 'DERIVED', 'citation': 'Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.'}, {'pmid': '34519356', 'type': 'DERIVED', 'citation': 'Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.'}, {'pmid': '33314078', 'type': 'DERIVED', 'citation': 'Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.'}, {'pmid': '19958532', 'type': 'DERIVED', 'citation': 'Oudemans-van Straaten HM, van Schilfgaarde M, Molenaar PJ, Wester JP, Leyte A. Hemostasis during low molecular weight heparin anticoagulation for continuous venovenous hemofiltration: a randomized cross-over trial comparing two hemofiltration rates. Crit Care. 2009;13(6):R193. doi: 10.1186/cc8191. Epub 2009 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'The low molecular weight heparin nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. Continuous hemofiltration is a renal replacement modality for intensive care patients with acute renal failure. Up to now it is not known whether nadroparin is removed by hemofiltration or not. Accumulation would increase the risk of bleeding.\n\nAim of the present study is to determine\n\n1. whether nadroparin accumulates in plasma\n2. whether nadroparin is removed by filtration and whether removal depends on hemofiltration dose\n3. the effects of nadroparin during critical illness on coagulation and anticoagulation', 'detailedDescription': 'The low molecular weight heparin (LMWH) nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. LMWH accumulate in patients with chronic renal failure. Continuous venovenous hemofiltration (CVVH) is a renal replacement modality for intensive care patients with acute renal failure. Up to now it is not known whether nadroparin is removed by hemofiltration or not. If not, accumulation is expected and the risk of bleeding for the patient increases. Because critically ill patients are at increased risk of bleeding, this question is crucial.\n\nIf nadroparin would be removed by filtration, removal is expected to depend on hemofiltration dose (to be greater with a higher dose)\n\nWe therefore designed a randomized controlled cross-over trial in the setting of critical illness and acute renal failure comparing the anticoagulant effect of nadroparin (anti-Xa) between two doses of CVVH in the patients blood, in the extracorporeal circuit and in the ultrafiltrate.\n\nBecause hemostasis in critically ill patients is not only influenced by anticoagulation but also by the critical illness and the extracorporeal circuit, we also measure other hemostatic markers, especially the endogenous thrombin potential (ETP), which seems the most global marker of hemostasis, incorporating procoagulant and anticoagulant effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute renal failure requiring renal replacement therapy\n\nExclusion Criteria:\n\n* (recent) bleeding or a suspicion of bleeding necessitating transfusion,\n* need of therapeutic anticoagulation or\n* (suspected) heparin-induced thrombocytopenia'}, 'identificationModule': {'nctId': 'NCT00965328', 'briefTitle': 'Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration', 'organization': {'class': 'OTHER', 'fullName': 'Onze Lieve Vrouwe Gasthuis'}, 'officialTitle': 'Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration (CVVH), a Randomized Cross-over Trial Comparing Hemostasis Between Two Hemofiltration Rates', 'orgStudyIdInfo': {'id': 'WO 06044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'hemofiltration at 4L/h', 'description': 'Hemofiltration was started at 4L/h and crossed over to 2L/h after 60 minutes of hemofiltration', 'interventionNames': ['Procedure: CVVH 4 to 2 L/h']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hemofiltration at 2L/h', 'description': 'hemofiltration was started at 2L/h and crossed over to 4L/h after 60 min', 'interventionNames': ['Procedure: CVVH 2 to 4L/h']}], 'interventions': [{'name': 'CVVH 4 to 2 L/h', 'type': 'PROCEDURE', 'otherNames': ['continuous venovenous hemofiltration'], 'description': 'CVVH is initiated at 4L/h and is converted to 2L/h after 60 min', 'armGroupLabels': ['hemofiltration at 4L/h']}, {'name': 'CVVH 2 to 4L/h', 'type': 'PROCEDURE', 'otherNames': ['continous venovenous hemofiltration'], 'description': 'CVVH is initiated at 2L/h and is converted to 4L/h after 60 min', 'armGroupLabels': ['hemofiltration at 2L/h']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090AC', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Heleen Oudemans-van Straaten, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Onze Lieve Vrouwe Gasthuis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Onze Lieve Vrouwe Gasthuis', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'HM Oudemans-van Straaten', 'oldOrganization': 'Onze Lieve Vrouwe Gasthuis'}}}}