Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-01-04 @ 6:51 PM
Study NCT ID:
NCT06103292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calcium Levels in Major Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-22', 'studyFirstSubmitDate': '2023-10-22', 'studyFirstSubmitQcDate': '2023-10-22', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'follow up ionized calcium level', 'timeFrame': '24 hrs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Trauma']}, 'referencesModule': {'references': [{'pmid': '7869433', 'type': 'BACKGROUND', 'citation': 'Sauaia A, Moore FA, Moore EE, Moser KS, Brennan R, Read RA, Pons PT. Epidemiology of trauma deaths: a reassessment. J Trauma. 1995 Feb;38(2):185-93. doi: 10.1097/00005373-199502000-00006.'}, {'pmid': '9751548', 'type': 'BACKGROUND', 'citation': 'Heckbert SR, Vedder NB, Hoffman W, Winn RK, Hudson LD, Jurkovich GJ, Copass MK, Harlan JM, Rice CL, Maier RV. Outcome after hemorrhagic shock in trauma patients. J Trauma. 1998 Sep;45(3):545-9. doi: 10.1097/00005373-199809000-00022.'}, {'pmid': '19393349', 'type': 'BACKGROUND', 'citation': 'Zink KA, Sambasivan CN, Holcomb JB, Chisholm G, Schreiber MA. A high ratio of plasma and platelets to packed red blood cells in the first 6 hours of massive transfusion improves outcomes in a large multicenter study. Am J Surg. 2009 May;197(5):565-70; discussion 570. doi: 10.1016/j.amjsurg.2008.12.014.'}, {'pmid': '5551141', 'type': 'BACKGROUND', 'citation': 'Barry GD. Plasma calcium concentration changes in hemorrhagic shock. Am J Physiol. 1971 Apr;220(4):874-9. doi: 10.1152/ajplegacy.1971.220.4.874. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'To assess and treat The calcium level abnormalities in major trauma pre and post receiving blood transfusions .', 'detailedDescription': 'Primary objective:\n\n* to evaluate the level of ionized calcium in multiple trauma patients with massive hemorrhage\n\nSecondary objective:\n\n* to build a relation between the level of ionized calcium and the degree of hemorrhagic shock'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In this study all consecutive adult multiple trauma patients presenting to the emergency department with the inclusion criteria until the sample size is satisfied.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\>18 years old - \\< 70 years\n2. Major trauma patients.\n3. Admission and Ionized calcium measurement before blood transfusions\n\nExclusion Criteria:\n\n1. patients below 18 years or \\> 70 years of age.\n2. Pregnant women\n3. Arrested patients\n4. Patients managed outside the hospital and had received blood transfusions'}, 'identificationModule': {'nctId': 'NCT06103292', 'briefTitle': 'Calcium Levels in Major Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Ionized Calcium Level Abnormalities In Major Trauma Patients Pre And Post Receiving Blood Transfusion And Its Relation To Mortality Rate', 'orgStudyIdInfo': {'id': 'Calcium abnormaities in trauma'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ionized calcium levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'measuring calcium level in trauma patients'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'HOSSAM ISMAIL, MBBCH', 'role': 'CONTACT', 'email': 'hosoabdo1996@gmail.com', 'phone': '+201090703142'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hossam Abdel Rahman Ahmed Ismail', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Hossam Ismail', 'investigatorFullName': 'Hossam Abdel Rahman Ahmed Ismail', 'investigatorAffiliation': 'Assiut University'}}}}