Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-05 @ 6:07 PM
Study NCT ID:
NCT03149250
Status:
UNKNOWN
Last Update Posted:
2017-08-22
First Post:
2017-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}], 'ancestors': [{'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': '2017-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2017-05-03', 'studyFirstSubmitQcDate': '2017-05-10', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the aggregation curve in the ADPtest of the Multiple Electrode Aggregometry', 'timeFrame': 'Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study', 'description': 'ADP induced platelet aggregation'}], 'secondaryOutcomes': [{'measure': 'Area under the aggregation curve in the ASPItest of the Multiple Electrode Aggregometry', 'timeFrame': 'Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study', 'description': 'Arachidonic acid induced platelet aggregation'}, {'measure': 'Area under the aggregation curve in the TRAPtest of the Multiple Electrode Aggregometry', 'timeFrame': 'Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study', 'description': 'Thrombin induced platelet aggregation'}, {'measure': 'Parameters of plasmatic coagulation system', 'timeFrame': 'Between 35th and 40th week of pregnancy; in control group 2 (not pregnant) within 1 week after inclusion into the study', 'description': 'von Willebrand Factor, Factor VIII, Factor XIII, parameter of conventional coagulation testing (apTT, INR, platelet count, Fibrinogen)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aggregometry'], 'conditions': ['Coagulation Disorder, Blood', 'Platelet Function']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the impact of preeclampsia on hemostasis.', 'detailedDescription': 'In comparison to healthy pregnant women and non-pregnant woman, this study analyses parameters of primary hemostasis and plasmatic coaguation in preeclamptic pregnant woman. Detailed analyses of the platelet function is performed using the Multiple Electrode Aggregometry, detailed analyses of the plasmatic coagulation syste is performed by isolated coaguation factor analyses and conventional coagulation analyses.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant patients suffering from preeclampsia, n = 20\n\nControl group 1: Healthy pregnant patients, not suffering from preeclampsia, n=20\n\nControl group 2: Healthy woman (age between 18 and 40y) that are not pregnant', 'genderDescription': 'Female (Study cohort is pregnant, control group should be female too)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Platelet count \\> 100 / nll\n* In study group and control group 1: Week of Pregnancy: 35-40\n* in control group 2: healthy, not pregnant woman\n\nExclusion Criteria:\n\n* Hereditary coagulopathy\n* Missing content of the patient / proband\n* Eclampsia\n* HELLP syndrome\n* CRP \\> 1 mg/dl\n* Fever (\\> 38°C)'}, 'identificationModule': {'nctId': 'NCT03149250', 'briefTitle': 'Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'Characteristics of Primary and Plasmatic Hemostasis in Preeclampsia - a Cross-sectional Study', 'orgStudyIdInfo': {'id': 'Hemostasis_Preeclampsia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant Preeclampsia', 'description': 'Pregnant between 35th and 40th week of pregnancy Preeclampisa\n\nIntervention: Aggregometry, Monitoring of plasmatic hemostasis: Aggregometry and conventional coagulation testing after blood sampling in the context of routinely performed blood sampling', 'interventionNames': ['Diagnostic Test: Aggregometry, Monitoring of plasmatic hemostasis']}, {'label': 'Pregnant No-Preeclampsia', 'description': 'Control Group 1 Pregnant between 35th and 40th week of pregnancy No Preeclampsia Healthy Intervention: Aggregometry, Monitoring of plasmatic hemostasis: Aggregometry and conventional coagulation testing after blood sampling in the context of routinely performed blood sampling', 'interventionNames': ['Diagnostic Test: Aggregometry, Monitoring of plasmatic hemostasis']}, {'label': 'Not Pregnant', 'description': 'Control group 2 Healthy and not pregnant control group\n\nIntervention: Aggregometry, Monitoring of plasmatic hemostasis: Aggregometry and conventional coagulation testing after blood sampling.', 'interventionNames': ['Diagnostic Test: Aggregometry, Monitoring of plasmatic hemostasis']}], 'interventions': [{'name': 'Aggregometry, Monitoring of plasmatic hemostasis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Multiple Electrode Aggregometry using the Multiplate system Coagulation factor analyses (FXIII, FVIII, vWF) Parameters of conventional coagulation testing (aPTT, INR, Platelet count)', 'armGroupLabels': ['Not Pregnant', 'Pregnant No-Preeclampsia', 'Pregnant Preeclampsia']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Christian F Weber, MD, PhD', 'role': 'CONTACT', 'email': 'christian.weber@kgu.de', 'phone': '+49 69 6301 5514'}, {'name': 'Niels Loechelt, MD', 'role': 'CONTACT', 'email': 'niels.loechelt@kgu.de', 'phone': '+49 69 6301 5514'}], 'overallOfficials': [{'name': 'Christian F Weber, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goethe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Christian F. Weber', 'investigatorFullName': 'Christian F. Weber, MD', 'investigatorAffiliation': 'Cooperative Weichteilsarkom Study Group'}}}}