Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-07-06 @ 2:09 AM
Study NCT ID:
NCT03801135
Status:
UNKNOWN
Last Update Posted:
2019-01-11
First Post:
2018-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020275', 'term': 'Guillain-Barre Syndrome'}, {'id': 'D019846', 'term': 'Miller Fisher Syndrome'}, {'id': 'D020277', 'term': 'Polyradiculoneuropathy, Chronic Inflammatory Demyelinating'}, {'id': 'D019867', 'term': 'Anti-Glomerular Basement Membrane Disease'}], 'ancestors': [{'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'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005340', 'term': 'Fibrinogen'}], 'ancestors': [{'id': 'D000209', 'term': 'Acute-Phase Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-09-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2018-10-04', 'studyFirstSubmitQcDate': '2019-01-10', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of plasmapheresis replacement fluid type on fibrinogen level', 'timeFrame': 'Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]', 'description': 'Change of fibrinogen level after plasmapheresis treatment depending on replacement fluid type'}], 'secondaryOutcomes': [{'measure': 'Effect on coagulation tests after plasmapheresis - ROTEM EXTEM', 'timeFrame': 'Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]', 'description': 'ROTEM (EXTEM MCF) change after plasmapheresis treatment depending on replacement fluid type'}, {'measure': 'Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM', 'timeFrame': 'Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]', 'description': 'ROTEM (FIBTEM MCF) change after plasmapheresis treatment depending on replacement fluid type'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibrinogen concentrate', 'Fresh frozen plasma', 'ROTEM', 'Fibrinogen', 'Overall coagulation potential'], 'conditions': ['Humoral Rejection', 'Guillain-Barre Syndrome', 'Miller Fisher Syndrome', 'CIDP', 'Good Pasture Syndrome', 'Hyperviscosity Syndrome']}, 'referencesModule': {'references': [{'pmid': '39768590', 'type': 'DERIVED', 'citation': 'Zrimsek M, Gubensek J, Marn Pernat A. A Pilot Study on the Replacement of Fibrinogen with Fibrinogen Concentrates During Therapeutic Plasma Exchange with Mild to Moderate Bleeding Risk-A Comparison with Fresh Frozen Plasma and Albumin Replacement. J Clin Med. 2024 Dec 16;13(24):7662. doi: 10.3390/jcm13247662.'}]}, 'descriptionModule': {'briefSummary': 'Plasma exchange procedures remove procoagulant and anticoagulant factors. Every procedure increases the risk of bleeding and repeated procedures increase the risk of bleeding mostly because lower fibrinogen levels. The aim of study is to define coagulation status of patient after plasmapheresis with different laboratory tests and to investigate the possibility of fibrinogen concentrate replacement for the correction of induced coagulation disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Every patient who will need repeated plasmapheresis treatment in UKC Ljubljana\n\nExclusion Criteria:\n\n* pregnancy\n* coagulation disorders\n* Hypertriglyceridemia-induced acute pancreatitis\n* hepatic disorders'}, 'identificationModule': {'nctId': 'NCT03801135', 'briefTitle': 'Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement', 'orgStudyIdInfo': {'id': 'MPFhemostaza'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Electrolyte&Albumin Group', 'description': 'One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin.'}, {'type': 'EXPERIMENTAL', 'label': 'Fibrinogen Treatment Group', 'description': 'One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. Fibrinogen concentrate will be infused afterwards.', 'interventionNames': ['Drug: Fibrinogen concentrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FFP Treatment Group', 'description': 'One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma.', 'interventionNames': ['Other: Fresh Frozen Plasma']}], 'interventions': [{'name': 'Fibrinogen concentrate', 'type': 'DRUG', 'otherNames': ['Haemocomplettan'], 'description': 'Haemocomplettan will be infused after plasma exchange procedure', 'armGroupLabels': ['Fibrinogen Treatment Group']}, {'name': 'Fresh Frozen Plasma', 'type': 'OTHER', 'description': 'Fresh frozen plasma will be part of replacement fluid', 'armGroupLabels': ['FFP Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'state': 'Gorenjska', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Matej Zrimsek', 'role': 'CONTACT', 'email': 'matej.zrimsek@kclj.si', 'phone': '+38631789714'}], 'facility': 'University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Matej Zrimsek', 'role': 'CONTACT', 'email': 'matej.zrimsek@kclj.si', 'phone': '+38631789714'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Matej Zrimsek', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}