Methodology
Investigator will be following guidelines given by Society of Interventional Radiology for any intervention for coagulopathy correction.
Different procedures which are routinely carry out at our institute will be divided into high risk vs low risk as per Society of Interventional Radiology
Low risk: Peripherally inserted central catheter placement, Paracentesis, Thoracocentesis, Central venous cannulation, Lumbar puncture, Dialysis catheter placement
Low risk: Solid organ biopsies, Transjugular intrahepatic portosystemic shunts, Biliary interventions (cholecystostomy tube placement)
If the patient has evidence of ongoing sepsis (Positive blood culture, increased procalcitonin, shock, fever etc) or renal dysfunction, then he will be considered to be at high risk for the procedure.
After determining the risk category of the procedure, patients will decide to receive coagulopathy correction based on CCT (Society of Interventional Radiology). Those patients who do not require correction will be excluded.
For high risk procedures: PLT \< 20, INR \>2.5, Fibrinogen \< 100 mg/dL
For low risk procedures: PLT \< 30, INR \> 2.0, Fibrinogen \< 100 mg/dL
Those patients who will require coagulopathy correction will be randomized to receive correction based on standard ROTEM criteria versus Relaxed ROTEM criteria.
Standard ROTEM criteria:
CT EX \>80 s �' FFP/PCC(if volume overload)
MCF EX \<35 mm
MCF FIB \<8 mm �' Cryoprecipitate transfusion
MCF FIB ≥8 mm �' Platelets transfusion
Relaxed ROTEM criteria:
CT EX \>90 s �' FFP/PCC(if volume overload)
MCF EX \<30 mm
MCF FIB \<7 mm �' Cryoprecipitate transfusion
MCF FIB ≥7 mm �' Platelets transfusion
CCTs and/or ROTEM will be revised 12 hourly for 24 hours, then every 24 hours for next 48 hours; and if bleeding complications occur. However patients will undergo a procedure immediately after the coagulopathy correction based on baseline CCT and/or ROTEM. Patients will be followed up till day 28 post procedure for procedure related bleeding and non bleeding complications.
Acute kidney injury:
The Kidney Disease Improving Global Outcomes (KDIGO) guidelines define AKI as any of the following:
1. Increase in sCr by ≥0.3 mg/dl within 48 h or
2. Increase in sCr to ≥1.5x baseline, which is known or presumed to have occurred within the prior 7 days or
3. Urine volume \<0.5 ml/kg/h for 6 h
Sepsis:
The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
● Organ dysfunction can be identified as an acute change in total SOFA score ≥2 points consequent to the infection
Study population: All Cirrhosis and/or ACLF patients \>18 yrs, scheduled to undergo an high risk invasive procedure with severe coagulopathy requiring correction as per risk category and degree of coagulopathy on conventional coagulation tests.
Study design: Randomized controlled trial
Study period: 1 years
Sample size: 1050
Assuming that the proportion of patients requiring any blood products transfusion (i.e either FFP/platelets/ cryoprecipitate), in standard criteria group: 20% \[Ref:Pietri etal. HEPATOLOGY 2016;63:566-573\] and Relaxed group criteria: 13% (1/3rd decrease).
Two-sided significance level(1-alpha): 95
Power(1-beta, % chance of detecting): 80
Ratio of sample size, Unexposed/Exposed: 1
Percent of Unexposed with Outcome: 20
Percent of Exposed with Outcome: 13
Investigator decided to enroll total 1050 patients considering 10% dropout rate, 525 subjects in each arm
Patients were randomized to either Relaxed ROTEM or conventional ROTEM transfusion groups in a 1:1 ratio by random computer generated sequence
Monitoring and assessment: All the parameters of the objective and also noted any adverse effects.
Stopping rule: If patient decided to withdraw from study
