Trial name or title	Point-of-care Versus Standard Coagulation Tests Versus Restrictive Strategy to Guide Transfusion in Chronic Liver Failure Patients Requiring Central Venous Line: Prospective Randomized Trial (POCKET)
Methods	Allocation: Randomised Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment (three arms) Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Participants	Inclusion criteria: Adults (aged 18 years or older) with chronic liver failure (cirrhosis and/or chronic liver graft dysfunction) admitted to the intensive care unit and requiring insertion of a central line Exclusion criteria: Acute liver failure Use of therapeutic doses of oral or parenteral anticoagulants (unfractionated heparin or low molecular weight heparin or oral anticoagulants) Use of oral or parenteral platelet aggregation inhibitors Patients with von Willebrand disease Over-the-guidewire central venous catheter changing Patients previously included in this study protocol during the same hospital stay
Interventions	Arm 1: Coagulogram-based protocol Arm based on standard coagulation tests protocol to guide blood transfusion before central venous catheterisation. The possible components to be used include fresh frozen plasma, platelets (random or apheresis) and/or cryoprecipitate, based on international normalised ratio (INR), partial thromboplastin time (PTT), platelet count and/or fibrinogen INR > 1.5 or PTT > 50 seconds fresh frozen plasma is administered (dose: 10 mL/Kg) Platelets < 50 × 109/l platelet transfusion is administered (random or apheresis) Fibrinogen < 1.5g/l cryoprecipitate is administered Arm 2: Thromboelastometry-based protocol The interventions for this protocol include transfusion offresh frozen plasma, platelets (random or aphaeresis) and/or cryoprecipitate, based on rotational thromboelastometry (ROTEM(R)) CT (EXTEM) < 80 seconds and A10 (EXTEM) > 40 mm, then no blood transfusion is performed CT (EXTEM) > 80 seconds then fresh frozen plasma is administered (dose: 10 mL/Kg) A10 (EXTEM) < 40mm or A10 (FibTEM) > 10mm platelet transfusion is administered (random or apheresis) A10 (EXTEM) <40mm or A10 (FibTEM) < 10mm cryoprecipitate is administered Arm 3: Restrictive strategy The interventions for this protocol include transfusion of fresh frozen plasma and/or platelets (random or aphaeresis), based on INR and platelet count INR > 5 fresh frozen plasma is administered (dose: 10 mL/Kg) Platelets < 25 × 109/L platelet transfusion is administered (random or apheresis)
Outcomes	Primary outcome measures: Proportion of patients receiving a blood component transfusion - i.e. fresh frozen plasma, platelets and/or cryoprecipitate - before central venous catheterisation (on day of randomisation) Secondary outcome measures: Incidence of hemorrhagic complications associated with central venous catheterisation procedure (up to 24 hours) Incidence of acute immunologic and non-immunologic adverse effects of blood transfusion (up to 24 hours) Costs assessments (laboratory and blood transfusion) between the three strategies (up to 24 hours) Length of stay in ICU (up to 90 days) Length of stay in hospital (up to 180 days) Mortality rate (up to 28 days)
Starting date	September 2014
Contact information	Leonardo L Rocha, MD +55-11-21511500 lrocha23@gmail.com Thiago D Correa, MD, PhD +55-11-21511500 thiagodct@gmail.com
Notes	Estimated Enrollment: 165 Estimated Study Completion Date: December 2017 Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure) Location of trial: Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil, 05652-900