NCT02311985

Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
OTHER	Coagulogram-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).
OTHER	Thromboelastometry-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).
OTHER	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. 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).

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-12-09
• Last updated: 2018-03-07

Locations

1 site across 1 country: Brazil