Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-25 @ 3:03 PM
Study NCT ID:
NCT05985668
Status:
RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Towards Improved Diagnostics for Suspected Platelet Function Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2023-06-30', 'studyFirstSubmitQcDate': '2023-08-09', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Platelet count effect on platelet-thrombus formation on collagen surface', 'timeFrame': 'At study inclusion', 'description': 'Whole-blood platelet-thrombus formation on collagen surface as for primary outcome. Subgroup analysis for patients with platelet count \\< 150 x 10\\^9 /L.'}, {'measure': 'ddAVP effect on platelet-thrombus formation on collagen surface', 'timeFrame': 'Immediately before and 1 hour after administration of ddAVP.', 'description': 'Whole-blood platelet-thrombus formation on collagen surface, similar as for primary outcome measurement. In a subset of patients with a clinical indication (physician discretion).'}, {'measure': 'Thrombus formation on collagen/TF', 'timeFrame': 'At study inclusion', 'description': 'Thrombus formation on collagen surface/tissue-factor surface measured in a semi-automatic microchip flow chamber by a pressure sensor.'}], 'primaryOutcomes': [{'measure': 'Platelet-thrombus formation on collagen surface', 'timeFrame': 'At study inclusion', 'description': 'Whole-blood platelet-thrombus formation on collagen surface measured in a semi-automatic microchip flow chamber by a pressure sensor. Coagulation activation is inhibited.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diagnostic accuracy'], 'conditions': ['Platelet Function Disorder', 'Platelet Disorder', 'Thrombocytopathy']}, 'descriptionModule': {'briefSummary': "This study aims to improve platelet function testing during bleeding investigations. To this end, the study will evaluate the diagnostic accuracy of novel platelet function tests in patients with confirmed or suspected platelet function disorders. Study participants will be recruited from patients that are referred to or treated at the Coagulation Unit, Karolinska University Hospital, and Pediatric Coagulation Unit, Astrid Lingren Children's Hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients recruited at Karolinska University Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria, known defects:\n\n* Known platelet function disorder under follow-up at Karolinska University Hospital (genetic or functional assay)\n* High likelihood of platelet function disorder (aberrant screening test with inheritance)\n* Family investigation for platelet disorder\n\nExclusion Criteria, known defects::\n\n* Antiplatelet or anticoagulant drugs\n* vWF:GPIb below 0.40 IU/mL\n* Hematocrit below 0.35 or above 0.50\n* Other coagulation disorder\n\nInclusion Criteria, suspected platelet function disorder:\n\n* Bleeding investigation at Karolinska University Hospital\n\nExclusion Criteria, suspected platelet function disorder::\n\n* Antiplatelet or anticoagulant drugs\n* vWF:GPIb below 0.40 IU/mL\n* Hematocrit below 0.35 or above 0.50\n* Other coagulation disorder'}, 'identificationModule': {'nctId': 'NCT05985668', 'briefTitle': 'Towards Improved Diagnostics for Suspected Platelet Function Disorders', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Stockholm'}, 'officialTitle': 'Towards Improved Diagnostics for Suspected Platelet Function Disorders', 'orgStudyIdInfo': {'id': 'K-2023-0991'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suspected', 'description': 'Suspected Platelet Function Disorder during bleeding investigation'}, {'label': 'Confirmed', 'description': 'Confirmed Platelet Function Disorder by Functional or Genetic Assay, or confirmed negative by gold standard assay'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'David Schmidt, MD, PhD', 'role': 'CONTACT', 'email': 'david.schmidt@regionstockholm.se', 'phone': '0812370000'}], 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}