Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1. Ongoing bleeding 2. Bleeding within last 3 days 3. ACLF patients going for LT may be added in exclusion criteria 4. Antiplatelet or anticoagulant therapy (discontinued 5. Hemodialysis in last 3 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of patients requiring any blood products transfusion (i.e FFP / platelets / cryoprecipitate)Timepoint: At the time of procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the amount of cryoprecipitate transfused (units) in patients requiring cryoprecipitate transfusion per patientTimepoint: At the time of procedure.;To compare the amount of FFP transfused (mL) in patients requiring FFP transfusion per patientTimepoint: At the time of procedure.;To compare the amount of platelets transfused (SDAP units) in patients requiring platelet transfusion per patientTimepoint: At the time of procedure.;To compare the cost incurredTimepoint: At the time of procedure.;To compare the occurrence of bleeding, defined as overt bleeding or hemoglobin drop requiring transfusion with a target of 8 g/dL 28 days patient survivalTimepoint: 28 days;To compare the proportion of patients requiring cryoprecipitate transfusionTimepoint: At the time of procedure.;To compare the proportion of patients requiring FFP transfusionTimepoint: At the time of procedure.;To compare the proportion of patients requiring platelets transfusionTimepoint: At the time of procedure.;To compare the proportion of patients requiring tranexamic acid infusionTimepoint: At the time of procedure.;To compare the transfusion-related side effects, defined as any side effect occurring within 6 hours of blood products infusion; and Procedure-related complications other than bleedingTimepoint: 6 hours | — |
Countries
India
Contacts
Institute of Liver and Biliary Sciences