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

Not Applicable

Terminated

• Conditions: Liver Cirrhosis
• Interventions: Other: Thromboelastometry-based protocol; Other: Coagulogram-based protocol; Other: Restrictive strategy

• Registration Number: NCT02311985
• Lead Sponsor: Hospital Israelita Albert Einstein

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thromboelastometry-based protocol	Thromboelastometry-based protocol	Arm based on rotational thromboelastometry (ROTEM(R)) protocol to guide blood transfusion before central venous catheterization. The possible components to be used include fresh frozen plasma, platelets (random or aphaeresis) and or cryoprecipitate.
Coagulogram-based protocol	Coagulogram-based protocol	Arm based on standard coagulation tests protocol to guide blood transfusion before central venous catheterization. The possible components to be used include fresh frozen plasma, platelets (random or aphaeresis) and or cryoprecipitate.
Restrictive strategy	Restrictive strategy	Arm based on a restrictive protocol strategy based on INR/PT and platelets count. The possible components to be used include fresh frozen plasma and/or platelets (random or aphaeresis).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Length of stay in ICU	Up to 90 days
Incidence of hemorrhagic complications associated to central venous catheterization procedure	Day 1
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
Length of stay in hospital	Up to 180 days
Mortality rate	Up to 28 days

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 Sao Paulo, SP, Brazil