Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-17 @ 10:51 AM
Study NCT ID:
NCT02142166
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2014-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Biomarker in Serum, Cerebrospinal Fluid and Parenchyma in the Context of Aneurysmal Subarachnoid Hemorrhage.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015415', 'term': 'Biomarkers'}], 'ancestors': [{'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 310}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-31', 'studyFirstSubmitDate': '2014-04-30', 'studyFirstSubmitQcDate': '2014-05-19', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarker in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH', 'timeFrame': 'Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month.', 'description': 'Temporal development of alternative biomarkers in serum, cerebrospinal fluid and parenchyma after aneurysmal SAH, and their response as influenced by the treatment path.'}], 'secondaryOutcomes': [{'measure': 'Clinical outcome', 'timeFrame': 'Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month', 'description': 'Clinical outcome of patients depending on treatment algorithm and observed development of alternative biomarkers'}, {'measure': 'Image morphological outcome', 'timeFrame': 'Each participant will be followed at hospital stay for an expected average of 3 weeks. The outcome measure will be assessed after 24 month', 'description': 'Image morphological outcome of patients depending on treatment algorithm and observed development of alternative biomarkers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aneurysmal subarachnoid hemorrhage (ASH)', 'biomarker'], 'conditions': ['Aneurysmal Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '36712451', 'type': 'DERIVED', 'citation': 'Neumaier F, Stoppe C, Stoykova A, Weiss M, Veldeman M, Hollig A, Hamou HA, Temel Y, Conzen C, Schmidt TP, Dogan R, Wiesmann M, Clusmann H, Schubert GA, Haeren RHL, Albanna W. Elevated concentrations of macrophage migration inhibitory factor in serum and cerebral microdialysate are associated with delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. Front Neurol. 2023 Jan 13;13:1066724. doi: 10.3389/fneur.2022.1066724. eCollection 2022.'}, {'pmid': '35260962', 'type': 'DERIVED', 'citation': 'Veldeman M, Weiss M, Albanna W, Nikoubashman O, Schulze-Steinen H, Clusmann H, Hoellig A, Schubert GA. Incremental Versus Immediate Induction of Hypertension in the Treatment of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage. Neurocrit Care. 2022 Jun;36(3):702-714. doi: 10.1007/s12028-022-01466-7. Epub 2022 Mar 8.'}, {'pmid': '34604940', 'type': 'DERIVED', 'citation': 'Conzen C, Weiss M, Albanna W, Seyfried K, Schmidt TP, Nikoubashman O, Stoppe C, Clusmann H, Schubert GA. Baseline characteristics and outcome for aneurysmal versus non-aneurysmal subarachnoid hemorrhage: a prospective cohort study. Neurosurg Rev. 2022 Apr;45(2):1413-1420. doi: 10.1007/s10143-021-01650-x. Epub 2021 Oct 4.'}, {'pmid': '33866464', 'type': 'DERIVED', 'citation': 'Veldeman M, Weiss M, Simon TP, Hoellig A, Clusmann H, Albanna W. Body mass index and leptin levels in serum and cerebrospinal fluid in relation to delayed cerebral ischemia and outcome after aneurysmal subarachnoid hemorrhage. Neurosurg Rev. 2021 Dec;44(6):3547-3556. doi: 10.1007/s10143-021-01541-1. Epub 2021 Apr 17.'}, {'pmid': '32886914', 'type': 'DERIVED', 'citation': 'Veldeman M, Lepore D, Hollig A, Clusmann H, Stoppe C, Schubert GA, Albanna W. Procalcitonin in the context of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2020 Sep 4;135(1):29-37. doi: 10.3171/2020.5.JNS201337. Print 2021 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to improve the usability of biomarkers for the timely prediction of new complications following a cerebral hemorrhage, especially in combination with invasive, functional and local measurements for patients with aneurysmal subarachnoid hemorrhage (SAH). Based on analyzed biomarker profiles the chosen therapy efforts are assessed in their immediate and longer-term effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female, age ≥ 18 years\n* signed consent for participation in the study\n* signed consent for further analysis of the samples collected during the clinical routine\n* in-patients\n\nExclusion Criteria:\n\n* female or male patient \\<18 years\n* pregnancy, lactation\n* lack of signed informed consent for participation in the study\n* lack of signed consent for the further analysis of the samples collected during the clinical routine\n* taking a study drug within the last thirty days\n* Simultaneous participation in another clinical trial (except participation as control group)\n* persons who are in a dependent relationship or employment with the sponsor or investigator\n* persons housed for a judicial or administrative order in an institution'}, 'identificationModule': {'nctId': 'NCT02142166', 'acronym': 'bioSAB', 'briefTitle': 'The Role of Biomarker in Serum, Cerebrospinal Fluid and Parenchyma in the Context of Aneurysmal Subarachnoid Hemorrhage.', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Die Rolle Der Biomarker in Serum, Liquor Und Parenchym im Rahmen Der Aneurysmatischen Subarachnoidalblutung: Verlauf Und Korrelation zu Therapie Und Outcome - bioSAB -', 'orgStudyIdInfo': {'id': 'CTC-A 14-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAB analysis', 'description': 'Patients with acute aneurysmal SAH, confirmed by CT or MRI, or lumbar puncture\n\nDaily (21 days) analysis of Biomarker in serum, in liquor and in micro-dialysate', 'interventionNames': ['Procedure: Biomarker in serum, liquor, micro-dialysate']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Patients who undergo a lumbar puncture for myelography as part of the investigation of a cervical or lumbar foraminal stenosis without cranial or myeläre pathology -or- Patients who receive perioperative prophylactic lumbar drainage without cranial or myeläre pathology\n\nSingle analysis of Biomarker in serum and liquor', 'interventionNames': ['Procedure: Biomarker in serum and in liquor']}], 'interventions': [{'name': 'Biomarker in serum, liquor, micro-dialysate', 'type': 'PROCEDURE', 'description': 'Daily (21 days) analysis of biomarker in serum, in liquor and in micro-dialysate', 'armGroupLabels': ['SAB analysis']}, {'name': 'Biomarker in serum and in liquor', 'type': 'PROCEDURE', 'description': 'Single analysis of biomarker in serum and liquor', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Gerrit A. Schubert, PD. Dr.', 'role': 'CONTACT', 'email': 'gschubert@ukaachen.de', 'phone': '+492418088481'}, {'name': 'Gerrit A. Schubert, PD. Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Walid Albanna, Priv.-Doz. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Neurosurgery, University Hospital RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'centralContacts': [{'name': 'Walid Albanna, Priv.-Doz. Dr. med.', 'role': 'CONTACT', 'email': 'walbanna@ukaachen.de', 'phone': '+49 241 80 36706'}], 'overallOfficials': [{'name': 'Walid Albanna, Priv.-Doz. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery, University Hospital RWTH Aachen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Priv.-Doz. Dr. med. Walid Albanna', 'investigatorFullName': 'Walid Albanna', 'investigatorAffiliation': 'RWTH Aachen University'}}}}