Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-21 @ 11:08 PM
Study NCT ID:
NCT04146493
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2019-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heparin-Binding Protein and Heparins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma which could theoretically contain DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2019-10-23', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the level of Heparin-binding protein', 'timeFrame': 'Repeated blood sampling during minimum of 1 hour and maximum of 5 hours after given heparin', 'description': 'Blood samples are taken before and after given heparin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heparin-binding protein', 'Heparin', 'Biomarker'], 'conditions': ['Vascular Disease, Peripheral', 'Thromboprophylaxis', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '38318270', 'type': 'DERIVED', 'citation': 'Halldorsdottir H, Lindbom L, Ebberyd A, Oldner A, Weitzberg E. The effect of heparins on plasma concentration of heparin-binding protein: a pilot study. BJA Open. 2024 Jan 27;9:100256. doi: 10.1016/j.bjao.2023.100256. eCollection 2024 Mar.'}]}, 'descriptionModule': {'briefSummary': 'Heparin-Binding protein is a protein from primary and secretory granluae of white blood cells. It is released when white blood cells become activated and has been advocated as a biomarker for sepsis. The aim of this study is to find out if Heparins in clinical doses can change the level of Heparin-binding protein in plasma.', 'detailedDescription': 'Blood samples are taken from patients before and after Heparins in clinical doses. The effects of heparins on Heparin-binding protein concentration in plasma is measured. This is a small observational study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A) Patients operated for peripheral vascular disease or aortic disease B) Patients operated for major surgery C) Patients operated for open heart surgery with cardiopulmonary bypass.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned endovascular treatment of aortic aneurysm or peripheral vascular surgery where unfractionated heparin in \\>3000 units are given perioperatively\n* Planned subcutaneous low molecular weight heparin as a thromboprophylactic treatment after major surgery or on Intensive Care treated patients.\n* Planned open heart surgery with cardiopulmonary bypass.\n\nExclusion Criteria:\n\n* Under 18 years\n* Unable to get informed consent from patient or relative'}, 'identificationModule': {'nctId': 'NCT04146493', 'acronym': 'HepHep', 'briefTitle': 'Heparin-Binding Protein and Heparins', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Heparin-binding Protein and Heparins', 'orgStudyIdInfo': {'id': '4-2957/2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vascular surgery group', 'description': 'Patients which are given unfractionated heparin during their vascular surgery.', 'interventionNames': ['Diagnostic Test: Blood samples for Heparin-binding protein measurement']}, {'label': 'Thromboprophylaxis group', 'description': 'Patients which are given low molecular heparins as a thrombosprofylax after major surgery', 'interventionNames': ['Diagnostic Test: Blood samples for Heparin-binding protein measurement']}, {'label': 'Cardiothoracic surgery', 'description': 'Patients which are given high dose unfractionated heparin during their open heart surgey', 'interventionNames': ['Diagnostic Test: Blood samples for Heparin-binding protein measurement']}], 'interventions': [{'name': 'Blood samples for Heparin-binding protein measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood samples before and after given heparin', 'armGroupLabels': ['Cardiothoracic surgery', 'Thromboprophylaxis group', 'Vascular surgery group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17176', 'city': 'Stockholm', 'state': 'Solna', 'country': 'Sweden', 'facility': 'Halla Halldorsdottir', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Halla Halldorsdottir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Halla Halldorsdottir', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Halla Halldorsdottir', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}