Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT03812120
Status:
UNKNOWN
Last Update Posted:
2019-01-22
First Post:
2018-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
L-PRF in Cranial Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-01-17', 'releaseDate': '2024-12-04'}, {'resetDate': '2025-05-29', 'releaseDate': '2025-05-12'}], 'estimatedResultsFirstSubmitDate': '2024-12-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002559', 'term': 'Cerebrospinal Fluid Rhinorrhea'}], 'ancestors': [{'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086722', 'term': 'Rhinorrhea'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants stay masked during the trial, care provider and investigators are unblinded at the surgical procedure and from thereon.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-18', 'studyFirstSubmitDate': '2018-12-13', 'studyFirstSubmitQcDate': '2019-01-18', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate', 'timeFrame': '4 years', 'description': 'The success rate is considered a thigh closure of the dura in both groups, which means no CSF leakage. This success rate was estimated at 95% in both techniques.'}], 'secondaryOutcomes': [{'measure': 'Cost effectiveness evaluation', 'timeFrame': '4 years', 'description': 'A carefull registration of the used products (L-PRF versus commercial fibrin sealants), the quantity and the actual costs of these products will be noted during the operation procedure and will be analyzed.'}, {'measure': 'Complications', 'timeFrame': '4 years', 'description': 'Analysis of perioperative and postoperative complications, in particular surgical-site infection, treatment-site bleeding and CSF leakage.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['L-PRF', 'CSF leakage', 'fibrin sealants'], 'conditions': ['Cranial Sutures; Closure']}, 'referencesModule': {'references': [{'pmid': '38394657', 'type': 'DERIVED', 'citation': 'Coucke B, De Vleeschouwer S, van Loon J, Van Calenbergh F, Van Hoylandt A, Van Gerven L, Theys T. Leukocyte- and platelet-rich fibrin in cranial surgery: a single-blinded, prospective, randomized controlled noninferiority trial. J Neurosurg. 2024 Feb 23;141(2):500-508. doi: 10.3171/2023.12.JNS232125. Print 2024 Aug 1.'}, {'pmid': '36959672', 'type': 'DERIVED', 'citation': 'Coucke B, Van Hoylandt A, van Loon J, Van Calenbergh F, Van Gerven L, Theys T. Leukocyte- and platelet-rich fibrin in cranial surgery: study protocol for a prospective, parallel-group, single-blinded randomized controlled non-inferiority trial 1. Trials. 2023 Mar 23;24(1):219. doi: 10.1186/s13063-023-07252-w.'}]}, 'descriptionModule': {'briefSummary': 'The investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin sealants.', 'detailedDescription': 'The investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin sealants.\n\nApproximately 350 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded monocenter study to evaluate the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair (= primary objective).\n\nThe investigators will also evaluate if the use of L-PRF obviates the need for the use of other autologous grafts (e.g. muscle/fat), commercial collagen-based products (e.g. Tachosil) or articifial dura (=secondary objective).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing cranial neurosurgery whereby the dura is intentionally opened (supratentorial and infratentorial approach)\n* Age ≥ 18 years\n* Written informed consent\n* Willing to comply with the study schedule\n\nExclusion Criteria:\n\n* Participation in another clinical trial with study drugs or devices\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03812120', 'briefTitle': 'L-PRF in Cranial Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'L-PRF in Cranial Surgery: a Prospective, Randomized Trial', 'orgStudyIdInfo': {'id': 's61460'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Classical Treatment', 'description': 'In this arm, dural closure will be performed with the classical fibrine sealants.', 'interventionNames': ['Procedure: Dural closure with classical fibrin sealants']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'L-PRF', 'description': 'In this arm, dural closure will be performed with the autologous L-PRF', 'interventionNames': ['Procedure: Dural closure with L-PRF']}], 'interventions': [{'name': 'Dural closure with L-PRF', 'type': 'PROCEDURE', 'description': 'Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair', 'armGroupLabels': ['L-PRF']}, {'name': 'Dural closure with classical fibrin sealants', 'type': 'PROCEDURE', 'description': 'Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair', 'armGroupLabels': ['Classical Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Tom Theys, Prof', 'role': 'CONTACT', 'email': 'tom.theys@uzleuven.be', 'phone': '003216344290', 'phoneExt': '003216344290'}, {'name': 'Anais Van Hoylandt', 'role': 'CONTACT', 'email': 'anais.vanhoylandt@uzleuven.be', 'phone': '003216342012', 'phoneExt': '003216342012'}], 'facility': 'Tom Theys', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Tom Theys, Prof', 'role': 'CONTACT', 'email': 'tom.theys@uzleuven.be', 'phone': '003216344290', 'phoneExt': '003216344290'}, {'name': 'Anais Van Hoylandt, Sc', 'role': 'CONTACT', 'email': 'anais.vanhoylands@uzleuven.be', 'phone': '003216342012', 'phoneExt': '003216342012'}], 'overallOfficials': [{'name': 'Tom Theys, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Dr', 'investigatorFullName': 'Tom Theys', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-12-04', 'type': 'RELEASE'}, {'date': '2025-01-17', 'type': 'RESET'}, {'date': '2025-05-12', 'type': 'RELEASE'}, {'date': '2025-05-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Tom Theys, Professor, Dr, Universitaire Ziekenhuizen KU Leuven'}}}}