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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
74
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.
Standard of care
Changi General Hospital
Singapore, Singapore
RECRUITINGDifference 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.
Time frame: 24 months
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. 1. Immediate Bleeding (\<24 hours of procedure) 2. Delayed bleeding (\> 24 hours of procedure)
Time frame: 24 months
Transfusion related adverse events
Adverse events are defined as any side effect occurring within 6 hours of blood product infusion
Time frame: 24 months
Hospital Length of stay
Total hospital length of stay (in days)
Time frame: 24 months
30-day and 90-day survival
Survival rate at 30-day and 90-day from time of procedure
Time frame: 24 months
Thrombotic Complications
Thrombotic events such as portal vein thrombosis, stroke which may be secondary to blood product transfusion
Time frame: 24 months
Procedure related complications-other than bleeding
Non-bleeding related complications, specific to procedure such as pneumothorax will be reviewed
Time frame: 24 months
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