Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT00178594
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Hemostasis in Bleeding and Thrombotic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'human whole blood and plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2002-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess primary and secondary hemostasis in individuals with bleeding and clotting disorders', 'timeFrame': '24 hours', 'description': 'Coagulation will be assessed by continuously recording clot firmness, thrombin generation, and platelet function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hereditary Bleeding disorder', 'Thrombotic Disorder'], 'conditions': ['Blood Coagulation Disorders, Inherited', 'Thrombotic Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of this study will be to assess the coagulation system in-vitro in a variety of bleeding and clotting disorders using the ROTEG analyzer and the thrombin generation assay.', 'detailedDescription': 'This is an exploratory study involving blood coagulation assays in a select group of individuals receiving treatment for their congenital or acquired bleeding or clotting disorder at UTHealth Houston. The ROTEG is a newly developed coagulation analyzer which allows the continuous assessment of whole blood coagulation from the formation of the first fibrin fibers and activated platelets, to the formation of a three-dimensional whole blood clot until the eventual dissolution of the clot. This device will not be used as a diagnostic or procedure tool. No recommendations regarding interpretation of the results or implications for future treatment will be provided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '98 Years', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with an acquired or congenital bleeding disorder or acquired thrombotic disorder receiving treatment for their condition at UTHealth Houston.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: patients with congenital or acquired bleeding or clotting disorders who have provided informed consent and/or assent\n\nExclusion Criteria: poor venous access'}, 'identificationModule': {'nctId': 'NCT00178594', 'briefTitle': 'Evaluation of Hemostasis in Bleeding and Thrombotic Disorders', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Evaluation of Hemostasis in Bleeding and Thrombotic Disorders Using the Roteg Analyzer and the Thrombin Generation Assay', 'orgStudyIdInfo': {'id': 'HSC-MS-02-174'}}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katherine Addy, RN, BSN, MPH', 'role': 'CONTACT', 'email': 'Katherine.E.Addy@uth.tmc.edu', 'phone': '713-500-8352'}, {'name': 'Miguel Escobar, MD', 'role': 'CONTACT'}], 'facility': 'The Univerisity of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Randa Jalloul, MD', 'role': 'CONTACT', 'email': 'randa.j.jalloul@uth.tmc.edu', 'phone': '(832) 325-7131'}, {'name': 'Randa Jalloul, MD', 'role': 'CONTACT'}], 'facility': "UT Physicians Women's Center-Texas Medical Center", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Katherine Addy, RN, BSN, MPH', 'role': 'CONTACT', 'email': 'Katherine.E.Addy@uth.tmc.edu', 'phone': '713-500-8352'}, {'name': 'Daisy Garcia, RN, BSN', 'role': 'CONTACT', 'email': 'daisy.r.garcia@uth.tmc.edu', 'phone': '713-500-8386'}], 'overallOfficials': [{'name': 'Miguel Escobar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided at this time'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor - UTHealth McGovern Medical School', 'investigatorFullName': 'Miguel Escobar', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}