Clinical trial NCT05698134: Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.
Official title: Rotational Thromboelastometry (ROTEM™) Guided Transfusion for Elective Procedures in Patients With Cirrhosis (REduCe): An Open Label Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis, Liver
Keywords: ROTEM
Invasive Procedure
Cirrhosis
Blood Product
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 74
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into two parallel groups:

First 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
Primary purpose: TREATMENT

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

1. 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.
2. 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.

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

Primary outcomes:
measure: Difference in amount of blood products transfused
timeFrame: 24 months
Secondary outcomes:
measure: Peri-procedural bleeding complications
timeFrame: 24 months
measure: Transfusion related adverse events
timeFrame: 24 months
measure: Hospital Length of stay
timeFrame: 24 months
measure: 30-day and 90-day survival
timeFrame: 24 months
measure: Thrombotic Complications
timeFrame: 24 months
measure: Procedure related complications-other than bleeding
timeFrame: 24 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
References: