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

Study Overview
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Brief Summary
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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
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Patients with cirrhosis who meets eligibility criteria will be divided into two groups 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. 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.

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

Conditions
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Cirrhosis, Liver

Intervention / Treatment
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* Diagnostic Test: ROTEM
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Cirrhosis undergoing elective procedure must meet all following criterias. Patients undergoing the following elective procedures will be included in the study Gastroscopy with endoscopic variceal ligation Colonoscopy with polypectomy and endoscopic mucosal resection ERCP with sphincterotomy Percutaneous liver biopsy Biopsy of other sites (excluding liver) Hepatic venous pressure gradient with or without liver biopsy Elective Transjugular Intrahepatic Portosystemic Shunt Portal Vein embolization Trans-arterial chemo-embolization (TACE) Thermal ablation of hepatocellular carcinoma Large volume paracentesis Central venous catheter insertion Thoracentesis Age: Older than 21 years Coagulopathy based on conventional coagulation tests which is defined as INR > 1.5 and/or aPTT > 1.5x ULN for PTT and/or Platelets < 50,000/mm3/uL Patients 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 bleeding Under 21 years of age Inability to obtain informed consent from patients Coagulation 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 carcinoma Patients who have received FFP, platelet transfusion, cryoprecipitate within last 7 days Patients with stage 4 or 5 chronic kidney disease Patients receiving renal replacement therapy Patients with active sepsis as defined by ACPP-SCCM criteria (21). Pregnant Women

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>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<br>* Standard of care<br>|
| Experimental: ROTEM guided Group<br>Participants will receive blood products transfusion based on ROTEM results | Diagnostic Test: ROTEM<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ROTEM, Invasive Procedure, Cirrhosis, Blood Product