Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT01539057
Status:
UNKNOWN
Last Update Posted:
2014-12-04
First Post:
2012-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of the Administration of Fibrinogen in Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016063', 'term': 'Blood Loss, Surgical'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005340', 'term': 'Fibrinogen'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-03', 'studyFirstSubmitDate': '2012-02-02', 'studyFirstSubmitQcDate': '2012-02-21', 'lastUpdatePostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients requiring transfusion of packed red blood cells during the procedure', 'timeFrame': 'intraoperative', 'description': 'record of number of red blood cell packeds transfused during the surgical procedure'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients requiring blood products other than red cell concentrates', 'timeFrame': 'intraoperative', 'description': '* Number of packed red cells transfused during surgery\n* Number of units of fresh frozen plasma transfused during surgery\n* Number of platelet units transfused during surgery\n* Grams of fibrinogen administered during surgery'}, {'measure': 'Operative outcome', 'timeFrame': '4 weeks', 'description': '* Operative mortality\n* Liver graft survival\n* Thrombotic complications of all types and causes'}, {'measure': 'liver transplantation outcome', 'timeFrame': '1 year', 'description': 'Follow-up of graft survival and patient mortality one year after liver transplantation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Liver', 'Surgery', 'hemostasis', 'coagulation', 'Fibrinogen'], 'conditions': ['Intraoperative Bleeding']}, 'referencesModule': {'references': [{'pmid': '39152310', 'type': 'DERIVED', 'citation': 'Perez L, Sabate A, Gutierrez R, Caballero M, Pujol R, Llaurado S, Penafiel J, Hereu P, Blasi A. Risk factors associated with blood transfusion in liver transplantation. Sci Rep. 2024 Aug 16;14(1):19022. doi: 10.1038/s41598-024-70078-2.'}, {'pmid': '37919695', 'type': 'DERIVED', 'citation': 'Caballero M, Sabate A, Perez L, Vidal J, Reverter E, Gutierrez R, Crespo G, Penafiel J, Blasi A. Factors associated with mechanical ventilation longer than 24 h after liver transplantation in patients at risk for bleeding. BMC Anesthesiol. 2023 Nov 2;23(1):356. doi: 10.1186/s12871-023-02321-8.'}, {'pmid': '28990201', 'type': 'DERIVED', 'citation': 'Blasi A, Sabate A, Beltran J, Costa M, Reyes R, Torres F. Correlation between plasma fibrinogen and FIBTEM thromboelastometry during liver transplantation: a comprehensive assessment. Vox Sang. 2017 Nov;112(8):788-795. doi: 10.1111/vox.12598. Epub 2017 Oct 8.'}, {'pmid': '26880105', 'type': 'DERIVED', 'citation': 'Sabate A, Gutierrez R, Beltran J, Mellado P, Blasi A, Acosta F, Costa M, Reyes R, Torres F. Impact of Preemptive Fibrinogen Concentrate on Transfusion Requirements in Liver Transplantation: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Am J Transplant. 2016 Aug;16(8):2421-9. doi: 10.1111/ajt.13752. Epub 2016 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'Objective:\n\n* To evaluate the efficacy of preoperative administration of fibrinogen in liver transplantation by maintaining a preoperative plasma level equal to 2.9 g / L compared with placebo, reflecting a reduction in the number of RBC units transfused during the procedure.\n* To determine the influence of fibrinogen administration on mortality and survival of liver graft evaluated one year after the procedure.\n* To determine the safety of fibrinogen administration recording thrombotic complications evaluated during hospitalization or at least 30 days postoperatively.', 'detailedDescription': 'Methods: A multicenter, randomized, double-blind, placebo-controlled study. One hundred thirty two patients (132) will randomly be assigned to:\n\nTreatment group, Fibrinogen administration; doses of fibrinogen: 1 g for an increase in the plasmatic value of fibrinogen of 0.29 g / L to obtain a value of 2.9 g / L.\n\nPlacebo group, to whom the same dose volume of saline will be administered.\n\nDeterminations of haematocrit, electrolytes and kidney function tests and coagulation and haemostasis and thrombelastography test are made at all stages of the proceeding. A standard protocol for intraoperative management will be applied. Blood loss, administration of blood products, fluid therapy, presence of reperfusion syndrome, operative complications and mortality and survival will be registered. Patients will be followed for one year after transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients candidates for liver transplantation\n* Patients with a value of pre-transplant plasma fibrinogen less than 2.9 g / L.\n\nExclusion Criteria:\n\n* Patients with a value of fibrinogen in the 24 hours prior to the intervention than 2.9 g / L.\n* Known history of thromboembolic events in 30 days\n* Known or suspected pregnancy\n* Previous randomization in this trial\n* Known or suspected allergy to trial products or related products\n* Known presence of congenital bleeding disorder. Patients treated with aspirin, warfarin\n* The following indications for transplantation: familial polyneuropathy, acute liver failure, biliary cirrhosis and sclerosing cholangitis, Budd-Chiari syndrome\n* Heart beating donors and living donor\n* Patient reluctant to participate in the trial'}, 'identificationModule': {'nctId': 'NCT01539057', 'acronym': 'FibstudLT', 'briefTitle': 'The Efficacy of the Administration of Fibrinogen in Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'A Multicenter, Placebo Controlled Study to Evaluate the Efficacy of the Administration of Fibrinogen on Blood Product Requirements in Liver Transplantation', 'orgStudyIdInfo': {'id': 'Promotor Code 1553-H-459'}, 'secondaryIdInfos': [{'id': '2010-024584-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous Fibrinogen', 'description': 'Fibrinogen will be administered until an expected plasmatic value of 2.9 g / L is achieved.', 'interventionNames': ['Drug: Fibrinogen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline Serum', 'description': 'the same dose in volume of saline dilution will be administered. The potential dose of fibrinogen required to obtain a final plasmatic reading of 2.9 g / L. will be computed. A serum will contain the corresponding ml of saline dilution', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Fibrinogen', 'type': 'DRUG', 'otherNames': ['Haemocomplettan', 'RiaSTAP'], 'description': 'The dose of fibrinogen should be calculated at 1 g of fibrinogen in order to obtain an increase in plasma fibrinogen value of 0.29 g / L to reach a final value of 2.9 g / L.\n\nFibrinogen ampoules powder prepared with water dilution and located in a serum at a concentration of 2g/100 ml, which will be administered by intravenous infusion for 10 minutes.\n\nAdministration before surgery starts', 'armGroupLabels': ['Intravenous Fibrinogen']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['physiologic serum'], 'description': 'the same dose in volume of water dilution will be administered. The potential dose of fibrinogen required to obtain a final plasmatic reading of 2.9 g / L. will be computed. A serum will contain the corresponding ml of water dilution. Administered before surgery starts', 'armGroupLabels': ['Saline Serum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Murcia', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Seville', 'state': 'Sevilla', 'country': 'Spain', 'facility': 'Hospital Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Bilbao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Cruces', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}], 'overallOfficials': [{'name': 'Antoni Sabate, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitari Bellvitge.IDIBELL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spanish Clinical Research Network - SCReN', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Anesthesiology', 'investigatorFullName': 'Antoni Sabate', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}