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

Not Applicable

Recruiting

• Conditions: Cirrhosis, Liver
• Interventions: Diagnostic Test: ROTEM; Other: Standard of care

• Registration Number: NCT05698134
• Lead Sponsor: Changi General Hospital

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.

Study Timeline

• Study Start: 2021-08-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-15
• Study First Submitted QC: 2023-01-24
• Last Update Submitted: 2023-01-24
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-05-28
• Study Completion: 2023-05-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ROTEM guided Group	ROTEM	Participants will receive blood products transfusion based on ROTEM results
Standard of care	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)

Primary Outcome Measures

Name	Time	Method
Difference in amount of blood products transfused	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 Outcome Measures

Name	Time	Method
Procedure related complications-other than bleeding	24 months	Non-bleeding related complications, specific to procedure such as pneumothorax will be reviewed
Peri-procedural bleeding complications	24 months	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.; 1. Immediate Bleeding (\<24 hours of procedure); 2. Delayed bleeding (\> 24 hours of procedure)
Transfusion related adverse events	24 months	Adverse events are defined as any side effect occurring within 6 hours of blood product infusion
30-day and 90-day survival	24 months	Survival rate at 30-day and 90-day from time of procedure
Hospital Length of stay	24 months	Total hospital length of stay (in days)
Thrombotic Complications	24 months	Thrombotic events such as portal vein thrombosis, stroke which may be secondary to blood product transfusion

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore