Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04133220
Status:
UNKNOWN
Last Update Posted:
2019-10-21
First Post:
2019-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2019-07-01', 'studyFirstSubmitQcDate': '2019-10-18', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ICAM-', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of ICAM-'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of Syndecan-1', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of Syndecan-1'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of vWF Ag', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of vWF Ag'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by vWF activity', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'vWF activity'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fg', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of Fg'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of t-PA'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of u-PA', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of u-PA'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of e-Selectin', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of e-Selectin'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of sCD40L', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of sCD40L'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction parameter assessed by plasma concentration of IL6', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of IL6'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of AT', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of AT'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fragments thrombin 1+2', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of Fragments thrombin 1+2'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of TAT complex', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of TAT complex'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of plasmin-antiplasmin complex', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of plasmin-antiplasmin complex'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 Ag', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of PAI-1 Ag'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of PAI-1 activity', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of PAI-1 activity'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of t-PA-PAI-1 complex', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of t-PA-PAI-1 complex'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of ADAMTS13 Ag', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of ADAMTS13 Ag'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by ADAMTS13 activity', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'ADAMTS13 activity'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of vWF:CB', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of vWF:CB'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Fibrin monomers', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of Fibrin monomers'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by Prothrombine Time', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'Prothrombine Time'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by Activated Partial Thromboplastin Time [APTT]', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'Activated Partial Thromboplastin Time \\[APTT\\]'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor IX', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of Factor IX'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor II', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of Factor II'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor VIII', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of Factor VIII'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor XII', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of Factor XII'}, {'measure': 'Hemostasis / platelet and endothelial dysfunction assessed by plasma concentration of Factor X', 'timeFrame': '12hours after chemotherapy initiation', 'description': 'plasma concentration of Factor X'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of serious bleeding events', 'timeFrame': '1 month', 'description': 'Time from inclusion to first serious bleeding event'}, {'measure': 'Cumulative incidence of thrombotic events', 'timeFrame': '1 month', 'description': 'Time from inclusion to first thrombotic event'}, {'measure': 'Overall survival', 'timeFrame': '1 month', 'description': 'Time from inclusion to death of any cause'}, {'measure': 'ICU length of stay', 'timeFrame': '1 month', 'description': 'duration of stay in ICU within the first month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemostasis'], 'conditions': ['Leukemia, Myeloid, Acute']}, 'descriptionModule': {'briefSummary': 'Hyper-leukocytosis \\> 50.109/L is observed in 15% of acute myeloid leukemia (AML).\n\nLevel of hyper-leukocytosis is linearly associated with the incidence of life threatening complications that lead to the early death in 25% of these patients.\n\nThe HEAL project is a prospective, uni-centric, observational study that plans to include a cohort of 50 patients presenting de novo AML with hyper-leukocytosis (HL) (\\> 50.109/L) and 10 controls. The aim of the study is to describe the relative proportion of various hemostasis components disturbances, endothelium alterations, platelet dysfunction and to calculate cumulative incidence of hemorrhagic and thrombotic complications as well as overall survival of patients presenting with HL AML.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute myleoid leukemia associated to hyper-leukocytosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* De novo AML\n* GB counts \\> 50 G/L\n* Eligible for intensive chemotherapy\n* no previous AML treatment\n\nExclusion Criteria:\n\n* secondary AML\n* relapse of AML\n* Acute promyelocytic leukemia\n* Previous antiplatelet or anticoagulant treatment'}, 'identificationModule': {'nctId': 'NCT04133220', 'acronym': 'HEAL', 'briefTitle': 'Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Characterization of Endothelial Activation Hemostasis Disturbances and Severe Bleeding Events in Hyperleukocytic Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': '190002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients with acute myeloid leukemia, associated to hyper leukocytosis'}, {'label': 'Control', 'description': 'Patients with acute myeloid leukemia, without hyper leukocytosis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}