Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-31 @ 3:00 PM
Study NCT ID:
NCT04825158
Status:
UNKNOWN
Last Update Posted:
2021-04-01
First Post:
2021-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Role of Hemostasis in Perioperative Anaphylaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006469', 'term': 'Hemoptysis'}, {'id': 'D000707', 'term': 'Anaphylaxis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '* Whole blood\n* Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2024-02-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2021-03-30', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet activation', 'timeFrame': 'As soon as possible after onset of anaphylaxis', 'description': 'Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count'}, {'measure': 'Platelet activation', 'timeFrame': '1-2 hours after the onset of anaphylaxis', 'description': 'Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count'}, {'measure': 'Platelet activation', 'timeFrame': '24 hours after the onset of anaphylaxis', 'description': 'Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count'}, {'measure': 'Platelet activation', 'timeFrame': 'During the allergic workup (4-6 weeks after)', 'description': 'Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemoptysis', 'Perioperative Complication', 'Anaphylaxis']}, 'descriptionModule': {'briefSummary': 'Anaphylaxis is a severe and life-threatening complication during the perioperative period. Perioperative anaphylaxis is still associated with a significant mortality despite quick and efficient management using epinephrine, the mainstay of acute treatment. Experimental data and few case reports are suggesting that hemostasis, and more precisely platelets, could play a role in anaphylaxis. Our main hypothesis is that activation of the hemostatic system contributes to the severity of the reaction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will focus on any adult patient with a suspected diagnosis of perioperative anaphylactic shock', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient, male or female, adult\n* In the perioperative period\n* In whom the diagnosis of anaphylactic shock is suggested\n* Patient is giving his consent to participate in the study\n\nExclusion Criteria:\n\n* Subject under legal protection\n* Subject under guardianship or guardianship\n* Anemia less than 7 g /dl at the time of inclusion'}, 'identificationModule': {'nctId': 'NCT04825158', 'acronym': 'HEMOCANOPE', 'briefTitle': 'Study of the Role of Hemostasis in Perioperative Anaphylaxis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Study of the Role of Hemostasis in Perioperative Anaphylaxis', 'orgStudyIdInfo': {'id': '8030'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Charles-Ambroise TACQUARD, PHD', 'role': 'CONTACT', 'email': 'charlesambroise.tacquard@chru-strasbourg.fr', 'phone': '+333 69 55 16 08'}, {'name': 'Xavier DELABRANCHE, PHD', 'role': 'CONTACT', 'email': 'Xavier.delabranche@chru-strasbourg.fr', 'phone': '03.69.55.09.36'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}