Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-08 @ 10:56 AM
Study NCT ID:
NCT00622934
Status:
UNKNOWN
Last Update Posted:
2010-11-18
First Post:
2008-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009104', 'term': 'Multiple Trauma'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D000068817', 'term': 'Epoetin Alfa'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-17', 'studyFirstSubmitDate': '2008-02-13', 'studyFirstSubmitQcDate': '2008-02-21', 'lastUpdatePostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'apachi 2 saps 30 days mortality', 'timeFrame': 'untill discharge'}], 'secondaryOutcomes': [{'measure': '30 days mortality', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['multiple trauma'], 'conditions': ['Multiple Trauma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Erythropoietin decrease stress responses and inflammation in trauma patient.', 'detailedDescription': 'Transfusion of blood products has many disadvantages. Erythropoietin is used to increase red blood cells production and decrease such disadvantages.In some studies anti inflammatory effects is shown for Erythropoietin.\n\nOne of the most problems in the intensive care unit is stress response. we are going to evaluate effects of erythropoietin on oxidative stress and inflammation in trauma patient in intensive care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All multiple trauma patients\\>16 years with informed consent\n\nExclusion Criteria:\n\n* Hypertension\n* Allergy\n* Erythroid leukemia\n* Pregnancy and breast feeding\n* Pre operative patient\n* Severe cardiovascular and cerebrovascular diseases\n* Thromboembolic disorders'}, 'identificationModule': {'nctId': 'NCT00622934', 'acronym': 'EPREX', 'briefTitle': 'Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Relationship Between Clinical Recovery and Oxidative Stress and Inflammation Following Usage of Erythropoietin in Admitted Traumatic Patient In Intensive Care Unit', 'orgStudyIdInfo': {'id': '425/195 13/4/86'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: erythropoietin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'erythropoietin', 'type': 'DRUG', 'otherNames': ['EPREX'], 'description': '300mg/kg erythropoietin 3 times on the first week of admission', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'MOJTAHEDZADE', 'role': 'CONTACT', 'phone': '098216701041-9'}, {'name': 'MOHAMMADY', 'role': 'CONTACT', 'phone': '0989126053454'}, {'name': 'MOSTAFA MOHAMMADY', 'role': 'SUB_INVESTIGATOR'}, {'name': 'MOJTABA MOJTAHEDZADE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sina Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'mojtaba mojtahedzade', 'role': 'CONTACT', 'email': 'Mojtahed@sina.tums.ac.ir', 'phone': '0982166701041'}, {'name': 'mostafa mohammady', 'role': 'CONTACT', 'email': 'mohammady_m2007@yahoo.com', 'phone': '0982166735017'}], 'overallOfficials': [{'name': 'MOJTABA MOJTAHEDZADE', 'role': 'STUDY_CHAIR', 'affiliation': 'TUMS'}, {'name': 'MOSTAFA MOHAMMADY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TUMS'}, {'name': 'MOJTABA MOJTAHED', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TUMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Pharmaceutical Sciences Research Center Tehran University of Medical SCIENCES', 'oldOrganization': 'Pharmaceutical Sciences Research Center Tehran University of Medical SCIENCES'}}}}