Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-27 @ 10:42 PM
Study NCT ID:
NCT06111261
Status:
UNKNOWN
Last Update Posted:
2023-11-01
First Post:
2023-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Resuscitation With Albumin in Hemorrhagic Shock to Reduce Positive Fluid Balance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-10-30', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total fluid balance until physical hemostasis of bleeding is confirmed (ml)', 'timeFrame': 'Time from the initiation of massive transfusion protocol to physical hemostasis of bleeding was confirmed, up to 48 hours after initiation of massive transfusion protocol', 'description': 'Total fluid balance (Total fluid infused - Total output(urine output, bleeding, drainage, or etc.) until physical hemostasis of bleeding is confirmed (e.g. embolization, surgical exploration and ligation of vessel)'}], 'secondaryOutcomes': [{'measure': 'Time from the initiation of massive transfusion protocol to reversal of shock (min)', 'timeFrame': 'Time from the initiation of massive transfusion protocol to mean blood pressure was maintained higher than 65mmHg without vasopressor (min), up to 48 hours after initiation of massive transfusion protocol', 'description': 'Total time required to maintain mean blood pressure higher than 65mmHg without vasopressor'}, {'measure': 'Total amount of fluid until physical hemostasis of bleeding is confirmed (ml)', 'timeFrame': 'Time from the initiation of massive transfusion protocol to physical hemostasis of bleeding was confirmed, up to 48 hours after initiation of massive transfusion protocol', 'description': 'Total amount of transfusion and infusion of albumin product and crystalloid.'}, {'measure': 'Total length of ICU and hospital stay (days)', 'timeFrame': 'When discharge from ICU or hospital for any cause (days), through study completion, an average of 4 year', 'description': 'Total length of ICU and hospital stay'}, {'measure': 'In-hospital mortality', 'timeFrame': 'When mortality occurred, through study completion, an average of 4 year', 'description': 'Mortality occurred during hospital stay'}, {'measure': '7-day mortality', 'timeFrame': 'Within 7 days since the initiation of the massive transfusion protocols', 'description': '7-day mortality after the initiation of massive transfusion protocol'}, {'measure': '28-day mortality', 'timeFrame': 'Within 28 days since the initiation of the massive transfusion protocols', 'description': '28-day mortality after the initiation of massive transfusion protocol'}, {'measure': 'Acute kidney injury within 2 days of massive transfusion', 'timeFrame': 'up to 2 days of MTP', 'description': 'Incidence of Acute kidney injury (KidneyDisease:ImprovingGlobalOutcomes (KDIGO) stage 1 or above) within 2 days of massive transfusion'}, {'measure': 'Major pulmonary complication within 2 days of massive transfusion', 'timeFrame': 'up to 2 days of MTP', 'description': 'Major pulmonary complication(Pneumonia, PaO2/FiO2 ratio\\<300, pulmonary edema and pleural effusion) within 2 days of massive transfusion'}, {'measure': 'Transfusion-related adverse event', 'timeFrame': 'up to 2 days of MTP', 'description': 'Transfusion-related adverse event (TRALI, TACO, Anaphylaxis)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Massive transfusion protocol', 'Massive transfusion', 'Albumin'], 'conditions': ['Bleeding', 'Massive Hemorrhage', 'Massive Transfusion Protocol']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the effect of early albumin transfusion within massive transfusion protocol on fluid balance and reduced requirement of transfusion.', 'detailedDescription': 'Eligible patients who require massive transfusion will be randomized in a single-blind manner (participant) in a 1:1 ratio to Conventional Massive Transfusion Pro. tocol group (C-MTP) or Albumin Massive Transfusion Protocol group (A-MTP). When MTP is initiated according to the result of randomization, all patients(or a legal guardian) are informed about the study and potential risks and benefits. Study will be continued only in patients who give informed consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (19 or older)\n* Admitted or planned to admit surgical intensive care unit\n* Patients with decreased hemoglobin level more than 20% from baseline within 12 hours, Or\n* Patients who are suspected bleeding and hemodynamically unstable requiring more than 0.05mcg/kg/min of norepinephrine infusion to maintain mean blood pressure higher than 65mmHg\n\nExclusion Criteria:\n\n* Contraindicated to albumin product\n* patients with risk factors of increased circulatory volume (heart failure, pulmonary edema, end-stage renal disease with oliguria)\n* patients with hemolytic anemia\n* History of anaphylactic reaction to blood product'}, 'identificationModule': {'nctId': 'NCT06111261', 'acronym': 'ABSOLUTE', 'briefTitle': 'Initial Resuscitation With Albumin in Hemorrhagic Shock to Reduce Positive Fluid Balance', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Initial Resuscitation With Albumin in Hemorrhagic Shock to Reduce Positive Fluid Balance: A Randomized Controlled Trial (ABSOLUTE Trial)', 'orgStudyIdInfo': {'id': '2209-086-1359'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Albumin-massive transfusion protocol', 'description': 'At the initiation of MTP, 200ml of 20% albumin will be infused followed by transfusion of packed RBC:FFP:Platelet concentrate with ratio of 1:1:1.', 'interventionNames': ['Drug: Albumin solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional-massive transfusion protocol', 'description': 'At the initiation of MTP, Balanced crystalloid will be infused followed by transfusion of packed RBC:FFP:Platelet concentrate with ratio of 1:1:1. Albumin will be transfused according to the serum albumin level.', 'interventionNames': ['Drug: Balanced crystalloid solution']}], 'interventions': [{'name': 'Albumin solution', 'type': 'DRUG', 'description': '200ml of 20% Human Serum Albumin', 'armGroupLabels': ['Albumin-massive transfusion protocol']}, {'name': 'Balanced crystalloid solution', 'type': 'DRUG', 'description': 'Balanced crystalloid solution', 'armGroupLabels': ['Conventional-massive transfusion protocol']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Leerang Lim, M.D.', 'role': 'CONTACT', 'email': 'erange@snu.ac.kr', 'phone': '+82-2-2072-2467'}, {'name': 'Seung-young Oh, M.D.', 'role': 'CONTACT', 'email': 'faun1224@gmail.com', 'phone': '+82-2-2072-2966'}], 'overallOfficials': [{'name': 'Seung-young Oh, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical associate professor', 'investigatorFullName': 'Seung-Young Oh', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}