NCT05698134RecruitingNot Applicable
Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Changi General Hospital
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Difference in amount of blood products transfused
Study Overview
Brief Summary
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.
Detailed Description
Patients with cirrhosis who meets eligibility criteria will be divided into two groups
- 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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 21 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with Cirrhosis undergoing elective procedure must meet all following criterias.
- •Patients undergoing the following elective procedures will be included in the study
- •Gastroscopy with endoscopic variceal ligation
- •Colonoscopy with polypectomy and endoscopic mucosal resection
- •ERCP with sphincterotomy
- •Percutaneous liver biopsy
- •Biopsy of other sites (excluding liver)
- •Hepatic venous pressure gradient with or without liver biopsy
- •Elective Transjugular Intrahepatic Portosystemic Shunt
- •Portal Vein embolization
- •Trans-arterial chemo-embolization (TACE)
- •Thermal ablation of hepatocellular carcinoma
- •Large volume paracentesis
- •Central venous catheter insertion
- •Thoracentesis
- •Age: Older than 21 years
- •Coagulopathy based on conventional coagulation tests which is defined as
- •INR > 1.5 and/or aPTT > 1.5x ULN for PTT and/or
- •Platelets < 50,000/mm3/uL
- •Patients with acute decompensation, acute on chronic liver failure and acute liver failure.
- •Able to give informed consent.
Exclusion Criteria
- •Emergency procedures. (defined as life-saving procedures)
- •On-going bleeding
- •Under 21 years of age
- •Inability to obtain informed consent from patients
- •Coagulation disorders (other than those relating to liver disease)
- •Patients on anticoagulant medications (e.g. warfarin, enoxaparin, rivaroxaban, dabigatran, apixaban, heparin, clexane etc.)
- •Patients on anti-platelet aggregation agents other than aspirin (e.g. clopidogrel, ticagrelor)
- •Active malignancy except hepatocellular carcinoma
- •Patients who have received FFP, platelet transfusion, cryoprecipitate within last 7 days
- •Patients with stage 4 or 5 chronic kidney disease
- •Patients receiving renal replacement therapy
- •Patients with active sepsis as defined by ACPP-SCCM criteria (21).
- •Pregnant Women
Outcomes
Primary Outcomes
Difference in amount of blood products transfused
Time Frame: 24 months
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.
Secondary Outcomes
- Procedure related complications-other than bleeding(24 months)
- Peri-procedural bleeding complications(24 months)
- Transfusion related adverse events(24 months)
- 30-day and 90-day survival(24 months)
- Hospital Length of stay(24 months)
- Thrombotic Complications(24 months)
Investigators
Study Sites (1)
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