Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-29 @ 1:52 AM
Study NCT ID:
NCT05698134
Status:
UNKNOWN
Last Update Posted:
2023-01-26
First Post:
2023-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into two parallel groups:\n\nFirst group will receive standard of care based on institutional protocol for blood product transfusion Second group will receive ROTEM guided protocol for blood product transfusion'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-05-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2023-01-15', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in amount of blood products transfused', 'timeFrame': '24 months', 'description': 'The difference in amount/volume of blood products used(fresh frozen plasma in mls, cryoprecipitate in units and platelets in units) used in patients with cirrhosis undergoing elective procedure.'}], 'secondaryOutcomes': [{'measure': 'Peri-procedural bleeding complications', 'timeFrame': '24 months', 'description': '1\\. Peri-procedural bleeding complications (e.g. immediate, and delayed bleeding) defined as overt bleeding or haemoglobin drop requiring transfusion with a target of 8 g/dL.\n\n1. Immediate Bleeding (\\<24 hours of procedure)\n2. Delayed bleeding (\\> 24 hours of procedure)'}, {'measure': 'Transfusion related adverse events', 'timeFrame': '24 months', 'description': 'Adverse events are defined as any side effect occurring within 6 hours of blood product infusion'}, {'measure': 'Hospital Length of stay', 'timeFrame': '24 months', 'description': 'Total hospital length of stay (in days)'}, {'measure': '30-day and 90-day survival', 'timeFrame': '24 months', 'description': 'Survival rate at 30-day and 90-day from time of procedure'}, {'measure': 'Thrombotic Complications', 'timeFrame': '24 months', 'description': 'Thrombotic events such as portal vein thrombosis, stroke which may be secondary to blood product transfusion'}, {'measure': 'Procedure related complications-other than bleeding', 'timeFrame': '24 months', 'description': 'Non-bleeding related complications, specific to procedure such as pneumothorax will be reviewed'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ROTEM', 'Invasive Procedure', 'Cirrhosis', 'Blood Product'], 'conditions': ['Cirrhosis, Liver']}, 'referencesModule': {'references': [{'pmid': '39391324', 'type': 'DERIVED', 'citation': 'Kumar R, Ng LXL, Wong YJ, Tan CK, Wang LZ, Qiu TY, Wong B, Lin KW, Li JW, Kwek ABE, Ang TL, Gokhle RS, Sivanath TP. Rotational Thromboelastometry Reduces the Need for Preemptive Transfusion in Cirrhosis: A Randomized Controlled Trial (NCT:05698134). J Clin Exp Hepatol. 2025 Jan-Feb;15(1):102409. doi: 10.1016/j.jceh.2024.102409. Epub 2024 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'REDuCe is designed to evaluate the role of ROTEM™ in determining the need and the amount of pre-emptive blood products use in patients with cirrhosis undergoing elective procedures compared to the current standard of care. The secondary aim of this study is to evaluate ROTEM™ parameters in patients with acute decompensation, acute on chronic liver failure and acute liver failure and to co-relate it with the conventional coagulation tests.', 'detailedDescription': 'Patients with cirrhosis who meets eligibility criteria will be divided into two groups\n\n1. Those who are undergoing elective procedures will be randomized into 1:1 ratio into either standard of care (institutional transfusion protocol) or ROTEM guided protocol. Baseline ROTEM will be obtained before and after blood product transfusion.\n2. Those who are not for elective procedures and does not meet criteria for randomization will be entered into data collection for secondary endpoints analysis. These patients will have baseline ROTEM before transfusion and post transfusion ROTEM in those who require blood prodducts transfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with Cirrhosis undergoing elective procedure must meet all following criterias.\n\n1. Patients undergoing the following elective procedures will be included in the study\n\n 1. Gastroscopy with endoscopic variceal ligation\n 2. Colonoscopy with polypectomy and endoscopic mucosal resection\n 3. ERCP with sphincterotomy\n 4. Percutaneous liver biopsy\n 5. Biopsy of other sites (excluding liver)\n 6. Hepatic venous pressure gradient with or without liver biopsy\n 7. Elective Transjugular Intrahepatic Portosystemic Shunt\n 8. Portal Vein embolization\n 9. Trans-arterial chemo-embolization (TACE)\n 10. Thermal ablation of hepatocellular carcinoma\n 11. Large volume paracentesis\n 12. Central venous catheter insertion\n 13. Thoracentesis\n2. Age: Older than 21 years\n3. Coagulopathy based on conventional coagulation tests which is defined as\n\n 1. INR \\> 1.5 and/or aPTT \\> 1.5x ULN for PTT and/or\n 2. Platelets \\< 50,000/mm3/uL\n4. Patients with acute decompensation, acute on chronic liver failure and acute liver failure.\n5. Able to give informed consent.\n\nExclusion Criteria:\n\n1. Emergency procedures. (defined as life-saving procedures)\n2. On-going bleeding\n3. Under 21 years of age\n4. Inability to obtain informed consent from patients\n5. Coagulation disorders (other than those relating to liver disease)\n6. Patients on anticoagulant medications (e.g. warfarin, enoxaparin, rivaroxaban, dabigatran, apixaban, heparin, clexane etc.)\n7. Patients on anti-platelet aggregation agents other than aspirin (e.g. clopidogrel, ticagrelor)\n8. Active malignancy except hepatocellular carcinoma\n9. Patients who have received FFP, platelet transfusion, cryoprecipitate within last 7 days\n10. Patients with stage 4 or 5 chronic kidney disease\n11. Patients receiving renal replacement therapy\n12. Patients with active sepsis as defined by ACPP-SCCM criteria (21).\n13. Pregnant Women'}, 'identificationModule': {'nctId': 'NCT05698134', 'acronym': 'REduCe', 'briefTitle': 'Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'Changi General Hospital'}, 'officialTitle': 'Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '2020/3087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'Participants will receive blood products transfusion based on prevailing institution protocol, which is based on Platelet count and coagulation parameters (APTT, PT/INR)', 'interventionNames': ['Other: Standard of care']}, {'type': 'EXPERIMENTAL', 'label': 'ROTEM guided Group', 'description': 'Participants will receive blood products transfusion based on ROTEM results', 'interventionNames': ['Diagnostic Test: ROTEM']}], 'interventions': [{'name': 'ROTEM', 'type': 'DIAGNOSTIC_TEST', 'description': 'ROTEM is a commercially available whole blood Viscoelastic-Haemostatic Assay(VHA) point-of-care, global and dynamic haemostasis assessment tests that measures the viscoelastic changes occurring during the haemostatic process. They provide real-time, comprehensive reflection of the interaction between plasma, blood cells and platelets. It display hypo or hyper-coagulable features in patients with cirrhosis. It is widely used prior to cardiac, obstetric, trauma and liver transplant surgery to assess and correct for coagulation defects.', 'armGroupLabels': ['ROTEM guided Group']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'Standard of care', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Rahul Kumar, MBBS', 'role': 'CONTACT', 'email': 'rahul.kumar@singhealth.com.sg', 'phone': '65 6788 8833'}, {'role': 'CONTACT', 'email': 'rahul.kumar@singhealth.com.sg', 'phone': '65 6788 8833'}, {'name': 'Rahul Kumar, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chin Kimg Tan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}