Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT05814094
Status:
RECRUITING
Last Update Posted:
2025-05-31
First Post:
2022-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Red Blood Cell Transfusion in ECMO - A Feasibility Trial
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017707', 'term': 'Erythrocyte Transfusion'}], 'ancestors': [{'id': 'D016913', 'term': 'Blood Component Transfusion'}, {'id': 'D001803', 'term': 'Blood Transfusion'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2022-11-22', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in average lowest daily Hb concentration', 'timeFrame': 'From date of randomization to the end of the intervention (assessed up to day 28)', 'description': 'Primary Outcome Measure'}], 'secondaryOutcomes': [{'measure': 'Enrolment Rate', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Feasibility Outcome'}, {'measure': 'Reasons for not entering eligible patients into the study', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Feasibility Outcome'}, {'measure': 'Mean pre-transfusion Hb concentration immediately prior to an RBC transfusion', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Feasibility Outcome'}, {'measure': 'Proportion of RBC transfusions given according to allocated trigger', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Feasibility Outcome'}, {'measure': 'Time from measured Hb trigger value to transfusion', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Feasibility Outcome'}, {'measure': 'Number of RBC transfusions given prior to randomization', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Feasibility Outcome'}, {'measure': 'Frequency for not transfusing a patient who has reached a transfusion trigger', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Feasibility Outcome'}, {'measure': 'Reason/s for not transfusing a patient who has reached a transfusion trigger', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Feasibility Outcome'}, {'measure': 'Number of protocol deviations', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Feasibility Outcome'}, {'measure': 'Number and nature of Serious Adverse Events (SAEs)', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Safety and effectiveness outcome'}, {'measure': 'Total blood products used', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Safety and effectiveness outcome'}, {'measure': 'Major bleeding events (defined by ISTH criteria)', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Safety and effectiveness outcome'}, {'measure': 'Clinically relevant non-major bleeding events: GI haemorrhage, peripheral cannulation site bleeding, mediastinal cannulation site bleeding, surgical site bleeding', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Safety and effectiveness outcome'}, {'measure': 'Venous and arterial thromboembolic events', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Safety and effectiveness outcome'}, {'measure': 'New onset renal replacement therapy (RRT) during ECMO', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Safety and effectiveness outcome'}, {'measure': 'ECMO free days at day 60', 'timeFrame': '60 days', 'description': 'Safety and effectiveness outcome'}, {'measure': 'ICU free days at day 60', 'timeFrame': '60 days', 'description': 'Safety and effectiveness outcome'}, {'measure': 'Patient Reported Outcome Measure - WHODAS 2.0', 'timeFrame': '6 months', 'description': 'Disability Safety and effectiveness outcome'}, {'measure': 'Patient Reported Outcome Measure - IADL', 'timeFrame': '6 months', 'description': 'Independent Activities of Daily Living Safety and effectiveness outcome'}, {'measure': 'Patient Reported Outcome Measure - ADL', 'timeFrame': '6 months', 'description': 'Activity of Daily Living Safety and effectiveness outcome'}, {'measure': 'Patient Reported Outcome Measure - MoCA BLIND', 'timeFrame': '6 months', 'description': 'Cognitive Function Safety and effectiveness outcome'}, {'measure': 'Patient Reported Outcome Measure - EQ-5D-5L', 'timeFrame': '6 months', 'description': 'Quality of Life Safety and effectiveness outcome'}, {'measure': 'Patient Reported Outcome Measure - mRS', 'timeFrame': '6 months', 'description': 'Degree of Disability Safety and effectiveness outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hb', 'RBC transfusion', 'ECMO', 'feasibility', 'safety', 'blood transfusion', 'Australia', 'blood products', 'ICU', 'critical care', 'intensive care', 'bleeding', 'transfusion', 'Hb values'], 'conditions': ['Blood Loss Anemia', 'Extracorporeal Membrane Oxygenation Complication', 'Disability Physical', 'Cognitive Ability, General', 'Functional Status']}, 'descriptionModule': {'briefSummary': "Extracorporeal Membrane Oxygenation (ECMO) is an invasive and resource intense treatment used to support critically ill patients who have suffered severe cardiac arrest, cardiac failure or respiratory failure (including severe cases of COVID-19). ECMO acts as a mechanical circulatory support temporarily replacing the function of the heart or lungs by oxygenating blood and removing carbon dioxide, allowing time for these organs to recover. Many critically ill patients, including those on ECMO, have an increased risk of bleeding and reduced production/increased destruction of red blood cells (RBCs). This can lead to anaemia (haemoglobin levels \\<120 g/l), a condition where the body lacks enough healthy RBCs to carry enough oxygen to the body's tissues. Therefore, patients on ECMO frequently require RBC transfusion, with clinicians having to decide if administering an RBC transfusion (with its associated risks) is higher than tolerating complications of anaemia.\n\nROSETTA is a feasibility study that aims to determine the safety and feasibility of randomizing patients on ECMO to a restrictive RBC transfusion strategy (maintain Hb concentration above 70g/L) or to a more liberal transfusion strategy (maintain Hb concentration above 90g/L). Feasibility is defined as the ability to achieve a mean separation of at least 10g/L between the average lowest daily haemoglobin values in the two study groups.", 'detailedDescription': "A recent Cochrane analysis recommended a transfusion strategy that minimises the use of RBC transfusions in critically ill patients (by tolerating anaemia to avoid the adverse effects of an RBC transfusion). However, the analysis acknowledges that the degree of anaemia which can be tolerated by such patients is unknown, especially in patients suffering from conditions that limit oxygen delivery to the organs (like cardiac disease). As a result, the Australian Blood Authority's guidelines recommend an RBC transfusion to a patient at an Hb concentration of less than 70 g/L, while a transfusion at a Hb between 70 and 90 g/L should be based on the need to relieve clinical signs and symptoms of anaemia. However, this range is broad, and many studies in the general critically ill cohort have shown lower transfusion triggers are non-inferior to higher transfusion triggers.\n\nNo studies have been completed directly evaluating transfusion triggers in the ECMO patient cohort. ECMO patients differ to the general critically ill cohort as they have different physiological requirements, are at higher-risk for poor outcomes, and have an increased requirement for transfusions. Hb is a key driver of oxygen delivery (DO2), and critically ill ECMO patients are more commonly exposed to low DO2 due to low cardiac output and borderline oxygenation. Therefore, studies must be done to evaluate the optimal transfusion trigger/s (as determined by Hb concentration) that optimise mortality and long-term outcomes of ECMO patients.\n\nShould the ROSSETTA Pilot results indicate adequate separation of at least 10g/L between the two study groups, and that patient safety has not been adversely affected by the trial methods, feasibility will be deemed confirmed and the protocol not in need of modification prior to full trial commencement. At this point the ROSETTA Pilot will be transitioned into the Red Blood Cell Transfusion Domain, within RECOMMEND Platform Trial. The Primary and Secondary outcomes of the trial at large, will be answered during this stage."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients receiving ECMO\n* Age: 18 years or older\n\nExclusion Criteria:\n\n* Contraindication to RBC transfusion (including known patient preference)\n* Limitations of care put in place either through patient wishes or the treating medical teams\n* ECMO treatment for more than 12 hours. The start of ECMO is defined as the time of initiation of extracorporeal blood flow unless ECMO was initiated during a surgical intervention in which case the start is defined as the arrival time into the initial ICU.\n* The treating physician anticipates that ECMO treatment will cease before the end of tomorrow\n* Where the treating physician deems the study is not in the patient's best interest\n* Where the treating physician has concern regarding patient ability to tolerate restrictive or liberal transfusion trigger thresholds\n* Patients actively listed for a solid organ transplant\n* Patients who are suspected or confirmed to be pregnant\n* Previous ECMO treatment during the same hospital admission"}, 'identificationModule': {'nctId': 'NCT05814094', 'acronym': 'ROSETTA', 'briefTitle': 'Red Blood Cell Transfusion in ECMO - A Feasibility Trial', 'organization': {'class': 'OTHER', 'fullName': 'Australian and New Zealand Intensive Care Research Centre'}, 'officialTitle': 'Red Blood Cell Transfusion in ECMO - A Feasibility Trial', 'orgStudyIdInfo': {'id': 'ANZIC-RC/HB001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Restrictive Transfusion Trigger Group', 'description': "if a patient's Hb concentration reads ≤ 70g/L, one unit of RBC will be transfused. Additional units can be prescribed if required to raise the Hb concentration to above 70g/L.", 'interventionNames': ['Other: Red Blood Cell Transfusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liberal Transfusion Trigger Group', 'description': "if a patient's Hb concentration reads ≤ 90g/L, one or more units of RBC will be transfused. Additional units can be prescribed to raise the Hb concentration to greater than 90g/L", 'interventionNames': ['Other: Red Blood Cell Transfusion']}], 'interventions': [{'name': 'Red Blood Cell Transfusion', 'type': 'OTHER', 'description': "Following randomisation, if a patient's Hb concentration reads ≤ 70g/L, one unit of RBC will be transfused within 12 hours of the result becoming available. Additional units can be prescribed if required to raise the Hb concentration to above 70g/L. A transfusion above the restrictive threshold of 70g/L is discouraged.", 'armGroupLabels': ['Restrictive Transfusion Trigger Group']}, {'name': 'Red Blood Cell Transfusion', 'type': 'OTHER', 'description': "Following randomisation, if a patient's Hb concentration reads ≤ 90g/L, one or more units of RBC will be transfused in order to raise the Hb concentration to greater than 90g/L within 12 hours of the result becoming available. A decision not to transfuse below the threshold of 90g/L is discouraged.", 'armGroupLabels': ['Liberal Transfusion Trigger Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Heidi Buhr', 'role': 'CONTACT', 'email': 'heidi.buhr@health.nsw.gov.au', 'phone': '+61 2 9515 6007'}, {'name': 'Timothy Southwood', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Hergen Buscher, A/Prof', 'role': 'CONTACT', 'email': 'hergen.buscher@svhs.org.au'}], 'facility': "St Vincent's Health Sydney", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'centralContacts': [{'name': 'Curtis Hopkins, B.BioMed, MPH, MHA', 'role': 'CONTACT', 'email': 'anzicrc@monash.edu', 'phone': '+61 3 9903 0343'}], 'overallOfficials': [{'name': 'Hergen Buscher, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's Hospital, Sydney"}, {'name': 'Zoe McQuilten, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}, {'name': 'Carol Hodgson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}, {'name': 'Alistair Nichol, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}, {'name': 'Aidan Burrell, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}, {'name': 'Mark Dennis, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Prince Alfred Hospital, Sydney, Australia'}, {'name': 'Timothy Southwood, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Prince Alfred Hospital, Sydney, Australia'}, {'name': 'Alisa Higgins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}, {'name': 'Sally Newman, Nursing', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Vincent's Hospital, Sydney"}, {'name': 'Thao Le, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patient data is de-identified and only aggregate summaries published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Australian and New Zealand Intensive Care Research Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}