Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-27 @ 7:56 PM
Study NCT ID:
NCT03232359
Status:
COMPLETED
Last Update Posted:
2017-07-28
First Post:
2017-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immature Platelet Fraction as a Promising Biomarker in Prediction Outcome of HELLP Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D017359', 'term': 'HELLP Syndrome'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-01-01', 'size': 1265021, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-07-26T15:48', 'hasProtocol': True}, {'date': '2016-05-01', 'size': 3750682, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-07-26T15:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'targetDuration': '3 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-26', 'studyFirstSubmitDate': '2017-07-23', 'studyFirstSubmitQcDate': '2017-07-26', 'lastUpdatePostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical response after delivery', 'timeFrame': '48 hours after delivery', 'description': 'clinical and laboratory changes after delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre-Eclampsia, Severe', 'HELLP Syndrome', 'Microangiopathy']}, 'descriptionModule': {'briefSummary': 'Immature platelet fraction is a non-invasive test of real time thrombopoiesis. High IPF% has been suggested as an indicator of thrombocytopenia due to rapid platelet consumption. IPF% is able to discriminate between patients with TTP/HUS or SPE/HELLP', 'detailedDescription': 'Thrombotic microangiopathy (TMA) syndromes are extraordinarily diverse. Thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS) are the two most well known, and are considered to be the most serious. TTP-HUS occurs more commonly in women and among women is commonly associated with pregnancy.\n\nNevertheless, there are other pregnancy conditions that may manifest with TMA, including preeclampsia, eclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), in addition to acute fatty liver of pregnancy, antiphospholipid syndrome, and systemic lupus erythematosis.\n\nAssessment of immature platelets was introduced as a non-invasive test of real time thrombopoiesis. They are newly released in the circulation with a larger size \\& greater RNA content than mature platelets, and can be measured by automated haematology analyzer equipped with reticulocyte detection channel and described as immature platelet fraction (%-IPF) and immature platelet count (A-IPC).\n\nA high %-IPF has been suggested as an indicator of thrombocytopenia due to rapid platelet consumption, while a low %-IPF is characteristic of bone marrow suppression states. %-IPF/A-IPF has the competency to be performed routinely and, therefore, can provide therapeutic and diagnostic feedback in the life threatening conditions.\n\nThe present study aimed to show the utility of estimating %-IPF and A-IPC using a reticulocyte detection channel CBC autoanalyzer as a simple reproducible blood analysis to be employed in the differential diagnosis of pregnancy-associated thrombotic microangiopathic conditions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Group 1: SPE/HELLP group. This group included 24 pregnant women (gestational age of \\>20 weeks) who were diagnosed as having TMA with provisional diagnosis of pre-eclampsia, HELLP syndrome.\n\nGroup 2: TTP/HUS group. This group included 13 pregnant women (gestational age of \\>20 weeks) who were diagnosed as having TMA with provisional diagnosis of TTP/HUS.\n\nGroup 3: Control group. This group included 20 pregnant women (gestational age of \\>20 weeks) having normal pregnancy with normal blood pressure and platelet count.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 20 years of age\n* Pregnant with singleton intrauterine pregnancy\n* More than 20 weeks of gestation\n\nExclusion Criteria:\n\n* Congenital malformation and fetuses with chromosomal or genetic syndrome.\n* Recent blood transfusion.\n* Refusal to participate in the study.\n* BMI \\<18.\n* Placental abnormalities like velamentous insertion.\n* Multiple pregnancies.\n* Known kidney disease.\n* History of auto immune disease.'}, 'identificationModule': {'nctId': 'NCT03232359', 'briefTitle': 'Immature Platelet Fraction as a Promising Biomarker in Prediction Outcome of HELLP Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Assessment of Immature Platelet Fraction in Pregnancy-Associated Thrombotic Microangiopathy', 'orgStudyIdInfo': {'id': 'AAMABDELKADER 3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SPE/HELLP group', 'description': 'This group included 24 pregnant women (gestational age of \\>20 weeks) who were diagnosed as having TMA with provisional diagnosis of pre-eclampsia, HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis', 'interventionNames': ['Diagnostic Test: immature platelets fraction']}, {'label': 'TTP/HUS group', 'description': 'This group included 13 pregnant women (gestational age of \\>20 weeks) who were diagnosed as having TMA with provisional diagnosis of TTP/HUS. HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis', 'interventionNames': ['Diagnostic Test: immature platelets fraction']}, {'label': 'Control group', 'description': 'This group included 20 pregnant women (gestational age of \\>20 weeks) having normal pregnancy with normal blood pressure and platelet count.', 'interventionNames': ['Diagnostic Test: immature platelets fraction']}], 'interventions': [{'name': 'immature platelets fraction', 'type': 'DIAGNOSTIC_TEST', 'description': 'IPF-% and A-IPC using a reticulocyte detection channel CBC auto analyzer', 'armGroupLabels': ['Control group', 'SPE/HELLP group', 'TTP/HUS group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AYMAN ABDELKADER MOHAMED ABDELKADER', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'AYMAN ABDELKADER MOHAMED ABDELKADER', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}