Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-03-17 @ 3:24 AM
Study NCT ID:
NCT01370200
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2011-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regional Citrate Anticoagulation in Plasma Exchange Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005923', 'term': 'Glomerulosclerosis, Focal Segmental'}, {'id': 'D020275', 'term': 'Guillain-Barre Syndrome'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2011-06-02', 'studyFirstSubmitQcDate': '2011-06-08', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of plasma exchange, measuring immunoglobulins type G before and after the procedure, using 4% and 15% citrate as anticoagulants', 'timeFrame': 'the whole trial, approximately 3 years'}], 'secondaryOutcomes': [{'measure': 'The percentage of patients in whom there is a 50% reduction of immunoglobulins after plasma exchange using 4% and 15% citrate as anticoagulants', 'timeFrame': 'the whole trial, approximately 3 years'}, {'measure': 'Using 15% citrate as an anticoagulant during plasma exchange treatment is as safe as using 4% citrate as anticoagulant during plasma exchange treatment.', 'timeFrame': 'the whole trial, approximately 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['citrate', 'anticoagulation', 'plasma exchange', 'efficacy'], 'conditions': ['Focal Segmental Glomerulosclerosis', 'Guillain-Barre Syndrome']}, 'referencesModule': {'references': [{'pmid': '19695068', 'type': 'BACKGROUND', 'citation': 'Antonic M, Gubensek J, Buturovic-Ponikvar J, Ponikvar R. Comparison of citrate anticoagulation during plasma exchange with different replacement solutions. Ther Apher Dial. 2009 Aug;13(4):322-6. doi: 10.1111/j.1744-9987.2009.00733.x.'}]}, 'descriptionModule': {'briefSummary': 'The investigators want to compare the efficacy of plasma exchange treatment with using two different citrates ( 4% and 15% ) as anticoagulants in plasma exchange treatment.\n\nThe efficacy of plasma exchange treatment is better with using 15% trisodium citrate as anticoagulant during the plasma exchange procedure.', 'detailedDescription': 'To compare the elimination rate of immunoglobulins in plasma exchange treatment by using two differently concentrated citrates for anticoagulation during plasma exchange procedure. At the same time we want to compare acid-base , electrolyte status and anticoagulation protocol in two citrate groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who need plasma exchange treatment\n* human albumins as a replacement fluid\n\nExclusion Criteria:\n\n* anemia Hb less than 90'}, 'identificationModule': {'nctId': 'NCT01370200', 'briefTitle': 'Regional Citrate Anticoagulation in Plasma Exchange Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Regional Citrate Anticoagulation in Plasma Exchange Treatment', 'orgStudyIdInfo': {'id': '111/09/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '4% citrate', 'description': '4% trisodium citrate, starting infusion rate 180 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step', 'interventionNames': ['Procedure: plasma exchange treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': '15% citrate', 'description': '15% trisodium citrate, starting infusion rate 50 ml/h Interventions according to postfilter ionized calcium, change in 10 ml/h step', 'interventionNames': ['Procedure: plasma exchange treatment']}], 'interventions': [{'name': 'plasma exchange treatment', 'type': 'PROCEDURE', 'description': 'the therapeutic plasma exchange is the procedure of removing the plasma of the patient including pathological macromolecules and replacing it with the replacement fluid', 'armGroupLabels': ['15% citrate', '4% citrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Center for acute and complicated dialysis, Clinical department of nephrology, UMC Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Manja Antonič, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for acute and complicated dialysis, UMCLjubljana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Manja Antonic', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}