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

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.

Study Overview

• Status: Recruiting
• Conditions: Cirrhosis, Liver
• Intervention / Treatment: Other: Standard of care; Diagnostic test: ROTEM

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.

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Changi General Hospital
    • Contact: Rahul Kumar, MBBS; Phone Number: 65 6788 8833; Email: rahul.kumar@singhealth.com.sg
    • Contact: Phone Number: 65 6788 8833; Email: rahul.kumar@singhealth.com.sg
    • Principal Investigator: Rahul Kumar, MBBS
    • Sub-Investigator: Chin Kimg Tan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care; Participants will receive blood products transfusion based on prevailing institution protocol, which is based on Platelet count and coagulation parameters (APTT, PT/INR)	Other: Standard of care; Standard of care
Experimental: ROTEM guided Group; Participants will receive blood products transfusion based on ROTEM results	Diagnostic test: ROTEM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in amount of blood products transfused	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-procedural bleeding complications	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.; Immediate Bleeding (<24 hours of procedure); Delayed bleeding (> 24 hours of procedure)	24 months
Transfusion related adverse events	Adverse events are defined as any side effect occurring within 6 hours of blood product infusion	24 months
Hospital Length of stay	Total hospital length of stay (in days)	24 months
30-day and 90-day survival	Survival rate at 30-day and 90-day from time of procedure	24 months
Thrombotic Complications	Thrombotic events such as portal vein thrombosis, stroke which may be secondary to blood product transfusion	24 months
Procedure related complications-other than bleeding	Non-bleeding related complications, specific to procedure such as pneumothorax will be reviewed	24 months

Collaborators and Investigators

• Sponsor: Changi General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): May 28, 2023
• Study Completion (Anticipated): May 28, 2023

Study Registration Dates

• First Submitted: January 15, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Estimate): January 26, 2023

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Cirrhosis; ROTEM; Invasive Procedure; Blood Product
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 2020/3087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No