Liver Cirrhosis
Conditions
Keywords
Liver cirrhosis, Blood coagulation, Thromboelastography, Blood transfusion, Catheterization, central venous
Brief summary
The aim of this study is to compare three different blood transfusion strategies for coagulopathy correction before central venous catheterization in patients with chronic liver failure (cirrhosis and/or chronic liver graft dysfunction) admitted in intensive care unit.
Detailed description
Central venous catheterization is a ubiquitous procedure in intensive care units and is mainly used for drug administration, hemodynamic monitoring and hemodialysis. Only in US more than five million catheters are inserted annually. One of the main complications associated to central venous lines are the mechanical ones, i.e. arterial puncture, bleeding and hematoma formation, which varies between 5% and 19%. The use of real-time ultrasonography to accomplish central venous catheterization was associated to a drastic reduction in complication rates, and when performed by trained personnel, some series show complications rates \<1%, even in patients with coagulopathy. Patients presenting with chronic liver failure has a complex coagulation system balance, resulting from reduction in the majority of procoagulant and anticoagulant factors, opposed by preservation of thrombin generation. Thus, these patients are prone to develop hemorrhagic and thrombotic phenomena. The coagulation of cirrhotic patients have been classically evaluated by standard coagulation tests. Nevertheless, these tests present important limitations, as evaluation of plasmatic component only, and do not predict bleeding risk. The thromboelastometry is a point-of-care real-time coagulation system evaluation with the advantage of evaluating the cellular and plasmatic components of the coagulation and present a more comprehensive evaluation of blood coagulation, specially in cirrhotics. This technology is associated with reduced costs in diverse clinical settings. In clinical practice, approximately 90% of physicians empirically transfuse blood components to cirrhotic patients before invasive procedures. This practice is associated to increased risks related to blood transfusion per se, e.g. blood borne infections, immunologic and non-immunologic adverse reactions, to cite some. Several randomized clinical trials have shown that restrictive blood transfusion strategies are associated to better outcomes, including mortality.
Interventions
OTHERCoagulogram-based protocol
The interventions for this protocol include transfusion of fresh frozen plasma, platelets (random or aphaeresis) and/or cryoprecipitate, based on international normalised ratio (INR), partial thromboplastin time (PTT), platelet count and/or fibrinogen. If INR \>1.5 or PTT \>50 sec., fresh frozen plasma is administered (dose: 10 mL/Kg); and/or platelets \<50,000/microliter, random or aphaeresis platelets are administered (01 unit/Kg or 01 aphaeresis); and/or fibrinogen \<150 mg/dL, cryoprecipitate is administered (dose: 01 unit/Kg).
OTHERThromboelastometry-based protocol
The interventions for this protocol include transfusion of fresh frozen plasma, platelets (random or aphaeresis) and/or cryoprecipitate, based on rotational thromboelastometry (ROTEM(R)). If CTex \<80 sec. and A10ex \>40 mm, then no blood transfusion is performed; when CTex \>80s, then fresh frozen plasma is administered (dose: 10 mL/Kg); and/or A10ex \<40 mm or A10fib \>10 mm, random or aphaeresis platelets are administered (01 unit/Kg or 01 aphaeresis); and/or A10ex \<40 mm or A10fib \<10 mm, cryoprecipitate is administered (dose: 01 unit/Kg).
OTHERRestrictive strategy
The interventions for this protocol include transfusion of fresh frozen plasma and/or platelets (random or aphaeresis), based on INR and platelet count. If INR \>5, fresh frozen plasma is administered (dose: 10 mL/Kg); and/or platelets \<25,000/microliter, random or aphaeresis platelets are administered (01 unit/Kg or 01 aphaeresis).
Sponsors
Hospital Israelita Albert Einstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic liver failure (cirrhosis or chronic graft dysfunction) from any cause and medical indication of central venous line placement
Exclusion criteria
* Acute liver failure or * Use of therapeutic doses of oral or parenteral anticoagulants (unfractionated heparin or low molecular weight heparin or oral anticoagulants) or * Use of oral or parenteral platelet aggregation inhibitors or * Patients with von Willebrand syndrome or * Over-the-guidewire central venous catheter changing * Patients previously included in this study protocol during the same hospital stay
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients submitted to blood components transfusion - i.e. fresh frozen plasma, platelets and/or cryoprecipitate - before central venous catheterization | Day of randomization |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of acute immunologic and non-immunologic adverse effects of blood transfusion | Day 1 |
| Costs assessments (laboratory and blood transfusion) between the three strategies | Day 1 |
| Incidence of hemorrhagic complications associated to central venous catheterization procedure | Day 1 |
| Length of stay in hospital | Up to 180 days |
| Mortality rate | Up to 28 days |
| Length of stay in ICU | Up to 90 days |
Countries
Brazil
Outcome results
None listed