Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-04-15 @ 4:53 PM
Study NCT ID:
NCT02016859
Status:
UNKNOWN
Last Update Posted:
2013-12-20
First Post:
2013-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Prospective Study of the Predicted Value of Immature Thrombocytes Counts in Three Different Groups of Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood and serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-15', 'studyFirstSubmitDate': '2013-11-10', 'studyFirstSubmitQcDate': '2013-12-15', 'lastUpdatePostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'clinical use of IPF as a prognostic factor', 'timeFrame': 'up to 12 months', 'description': 'this outcome is not uet based we need much more studies in order to be able to use IPF in daily clinical work'}], 'primaryOutcomes': [{'measure': 'Time to recovery from sepsis or time to death', 'timeFrame': '6 months', 'description': "the primary outcome is the result of the patient's admission on which data analysis will be based"}], 'secondaryOutcomes': [{'measure': 'Predicting value of IPF for prognosis', 'timeFrame': 'baeline 6 months', 'description': "after the analysis of the data we'll may ba able to assess the predicting value of the IPF in predicting severity of infection and prediciting prognosis of infection in the three groups described"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IPF Immature platelet fraction', 'ICU neutropenic fever', 'hip fracture', 'critically ill'], 'conditions': ['Critically Ill Patients', 'Neutropenic Fever Patients', 'Patients With Hip Fractures']}, 'referencesModule': {'references': [{'pmid': '19647322', 'type': 'RESULT', 'citation': 'Di Mario A, Garzia M, Leone F, Arcangeli A, Pagano L, Zini G. Immature platelet fraction (IPF) in hospitalized patients with neutrophilia and suspected bacterial infection. J Infect. 2009 Sep;59(3):201-6. doi: 10.1016/j.jinf.2009.07.007. Epub 2009 Jul 18.'}, {'pmid': '23093245', 'type': 'RESULT', 'citation': 'De Blasi RA, Cardelli P, Costante A, Sandri M, Mercieri M, Arcioni R. Immature platelet fraction in predicting sepsis in critically ill patients. Intensive Care Med. 2013 Apr;39(4):636-43. doi: 10.1007/s00134-012-2725-7. Epub 2012 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'Immature Platelet Fraction (IPF) is a new value in CBC blood tests Recent Studies showed that this value may be another prognostic factor in critically ill patients such as those admitted to ICU, or those with neutropenic Fever.\n\nThe purpose of the study is to check if the IPF may be used as a prognostic Factor in these patients', 'detailedDescription': "In this study we have 3 groups of patients\n\n* Patients admitted to ICU\n* Patients admitted with neutropenic fever\n* Patients admitted with hip fractures it is a prospective study, not interventional, we'll take blood samples of these patients including CBC count eith IPF and other inflammation markers such as CRP and we'll compare CRP to IPF in addition to clinical follow-up of the patient till discharge.\n\nAt the end of this study we'll compare the efficacy of IPF as a prognostic Factor in these patients"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'admmitted patients to multiple departements', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Admission to hospital blood sample is taken between 24:00 pm till 15:00 pm\n\nExclusion Criteria:\n\n* blood sample is taken after 15:00 pm in the first day of admission during the week\n* blood sample is taken on weekend: thursday 15:00 pm till saturday 24:00 pm'}, 'identificationModule': {'nctId': 'NCT02016859', 'briefTitle': 'Observational Prospective Study of the Predicted Value of Immature Thrombocytes Counts in Three Different Groups of Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'orgStudyIdInfo': {'id': 'IPF-2013-Rambam'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically ill patients admitted to ICU', 'description': 'those patients who are admitted to ICU with multiorgan failure/injury', 'interventionNames': ['Other: Immature Platelet Fraction']}, {'label': 'Neutropinc Fever patients', 'description': 'admitted to ER, haemato-oncology or oncology', 'interventionNames': ['Other: Immature Platelet Fraction']}, {'label': "Patients of Hip's Fracture", 'description': 'admitted to orthopedic departement', 'interventionNames': ['Other: Immature Platelet Fraction']}], 'interventions': [{'name': 'Immature Platelet Fraction', 'type': 'OTHER', 'armGroupLabels': ['Critically ill patients admitted to ICU', 'Neutropinc Fever patients', "Patients of Hip's Fracture"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health care campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Yishai Ofran, Doctor', 'role': 'CONTACT', 'email': 'Y_ofran@ramabm.health.gov.il', 'phone': '009720502061524'}, {'name': 'Doaa Okasha, doctor', 'role': 'CONTACT', 'email': 'd_okasha@rambam.health.gov.il', 'phone': '009720502062701'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Yishai Ofran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Dr. Yishai Ofran', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}