Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT06285656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Femoral Blood Gas and Prediction of Postoperative Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019106', 'term': 'Postoperative Hemorrhage'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood gas'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '3 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-10-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-23', 'studyFirstSubmitDate': '2024-02-23', 'studyFirstSubmitQcDate': '2024-02-23', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eritrocyte replacement', 'timeFrame': '6 months', 'description': 'could we predict eritrocyte replacement at early postoperative period?'}], 'secondaryOutcomes': [{'measure': 'Postoperative Hemmorhagea', 'timeFrame': '6 months', 'description': 'Could we predict postoperative hemorrhage in the early postoperative period?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominal Surgery', 'Postoperative Hemorrhage', 'Blood Transfusion'], 'conditions': ['Postoperative Hemorrhage', 'Blood Transfusion']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://sjtrem.biomedcentral.com/articles/10.1186/s13049-023-01095-9', 'label': 'Femoral blood gas analysis, another tool to assess hemorrhage severity following trauma: an exploratory prospective study'}, {'url': 'https://pubs.asahq.org/anesthesiology/article/117/6/1276/13472', 'label': 'Prognostic Significance of Blood Lactate and Lactate Clearance in Trauma Patients'}, {'url': 'http://ccforum.biomedcentral.com/articles/10.1186/cc3888', 'label': 'Changes in central venous saturation after major surgery, and association with outcome'}]}, 'descriptionModule': {'briefSummary': 'Postoperative bleeding is still an important concern after major abdominal surgery. Postoperative bleeding is the most important determinant of morbidity and death. It results in longer hospital stays, the necessity for extra radiological tests, interventional radiology treatments, and the possibility of reoperation. Early detection of postoperative bleeding reduces morbidity and mortality with appropriate intervention.Simultaneous arterial and venous blood gas measurements can be used to quickly identify the degree of bleeding and the need for replacement in serious trauma patients brought to the emergency room.Lactate levels, venous oxygen saturation, and the differential in partial pressure of carbon dioxide between arterial and venous blood can all be used to indicate the requirement for replacement, as demonstrated in several studies. The purpose of this study is to evaluate lactate levels, venous oxygen saturation, and arterial-venous partial pressure of carbon dioxide difference in blood gas analysis in order to assess the severity of bleeding in patients undergoing major abdominal surgery as early as possible and perform replacement as soon as possible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients will have surgery at Ankara Bilkent City Hospital's General Surgery Clinic and then be transferred to the critical care unit.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with major abdominal surgery\n* Postoperative intensive care unit following\n* Accepting to participate in research\n\nExclusion Criteria:\n\n* Age under 18 years old\n* Pregnant patients\n* Do not accept to participate of study'}, 'identificationModule': {'nctId': 'NCT06285656', 'briefTitle': 'Femoral Blood Gas and Prediction of Postoperative Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Can Femoral Blood Gas Analysis Predict Early Bleeding and the Need for Blood Products After Abdominal Major Surgery: a Prospective Observational Study.', 'orgStudyIdInfo': {'id': 'ASH-KG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1/', 'description': 'Patients with postoperative hemmorhagia'}, {'label': 'Grup 2', 'description': 'Patients without postoperative hemmorhagia'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hüseyin Fahri Martlı', 'role': 'CONTACT', 'email': 'fahri_martli@hotmail.com', 'phone': '+905301794699'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not share other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}