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Recruiting NCT05698134

Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.

Conditions: Cirrhosis, Liver

Sex: All
Ages: 21 Years – 90 Years
Phase: NA
Enrollment: 74
Sponsor: Changi General Hospital

Location: Singapore

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.

Eligibility Criteria

Inclusion Criteria:Patients with Cirrhosis undergoing elective procedure must meet all following criterias.Patients undergoing the following elective procedures will be included in the studyGastroscopy with endoscopic variceal ligationColonoscopy with polypectomy and endoscopic mucosal resectionERCP with sphincterotomyPercutaneous liver biopsyBiopsy of other sites (excluding liver)Hepatic venous pressure gradient with or without liver biopsyElective Transjugular Intrahepatic Portosystemic ShuntPortal Vein embolizationTrans-arterial chemo-embolization (TACE)Thermal ablation of hepatocellular carcinomaLarge volume paracentesisCentral venous catheter insertionThoracentesisAge: Older than 21 yearsCoagulopathy based on conventional coagulation tests which is defined asINR > 1.5 and/or aPTT > 1.5x ULN for PTT and/orPlatelets < 50,000/mm3/uLPatients 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 bleedingUnder 21 years of ageInability to obtain informed consent from patientsCoagulation 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 carcinomaPatients who have received FFP, platelet transfusion, cryoprecipitate within last 7 daysPatients with stage 4 or 5 chronic kidney diseasePatients receiving renal replacement therapyPatients with active sepsis as defined by ACPP-SCCM criteria (21).Pregnant Women

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05698134). StuddyBuddy aggregates publicly available trial information.