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

Launched by CHANGI GENERAL HOSPITAL · Jan 24, 2023

Keywords

ClinConnect Summary

The clinical trial called REDuCe is investigating how a special tool called ROTEM™ can help doctors decide if patients with cirrhosis need blood products before certain planned medical procedures. This trial aims to find out if using ROTEM™ is better than the usual methods for determining blood product needs in patients undergoing procedures like liver biopsies or treatments for liver tumors. Additionally, the study will look at how ROTEM™ results compare to standard blood tests in patients with different levels of liver failure.

To participate in this trial, patients must be over 21 years old and have cirrhosis, which means their liver is damaged and not functioning properly. They should be scheduled for specific elective procedures and have certain blood test results that indicate they might need extra help with blood clotting. Participants will be closely monitored during their procedure, and their experiences will help researchers understand the best ways to manage blood product use in patients with liver issues. It's important to know that patients with certain conditions, like ongoing bleeding or severe kidney disease, won't be eligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with Cirrhosis undergoing elective procedure must meet all following criterias.
• • 1. Patients undergoing the following elective procedures will be included in the study
• • 1. Gastroscopy with endoscopic variceal ligation
• • 2. Colonoscopy with polypectomy and endoscopic mucosal resection
• • 3. ERCP with sphincterotomy
• • 4. Percutaneous liver biopsy
• • 5. Biopsy of other sites (excluding liver)
• • 6. Hepatic venous pressure gradient with or without liver biopsy
• • 7. Elective Transjugular Intrahepatic Portosystemic Shunt
• • 8. Portal Vein embolization
• • 9. Trans-arterial chemo-embolization (TACE)
• • 10. Thermal ablation of hepatocellular carcinoma
• • 11. Large volume paracentesis
• • 12. Central venous catheter insertion
• • 13. Thoracentesis
• • 2. Age: Older than 21 years
• • 3. Coagulopathy based on conventional coagulation tests which is defined as
• • 1. INR \> 1.5 and/or aPTT \> 1.5x ULN for PTT and/or
• • 2. Platelets \< 50,000/mm3/uL
• • 4. Patients with acute decompensation, acute on chronic liver failure and acute liver failure.
• • 5. Able to give informed consent.
• Exclusion Criteria:
• • 1. Emergency procedures. (defined as life-saving procedures)
• • 2. On-going bleeding
• • 3. Under 21 years of age
• • 4. Inability to obtain informed consent from patients
• • 5. Coagulation disorders (other than those relating to liver disease)
• • 6. Patients on anticoagulant medications (e.g. warfarin, enoxaparin, rivaroxaban, dabigatran, apixaban, heparin, clexane etc.)
• • 7. Patients on anti-platelet aggregation agents other than aspirin (e.g. clopidogrel, ticagrelor)
• • 8. Active malignancy except hepatocellular carcinoma
• • 9. Patients who have received FFP, platelet transfusion, cryoprecipitate within last 7 days
• • 10. Patients with stage 4 or 5 chronic kidney disease
• • 11. Patients receiving renal replacement therapy
• • 12. Patients with active sepsis as defined by ACPP-SCCM criteria (21).
• • 13. Pregnant Women