Thromboelastometry versus standard coagulation tests versus restrictive protocol to guide blood transfusion prior to central venous catheterization in cirrhosis: study protocol for a randomized controlled trial

Leonardo Lima Rocha, Camila Menezes Souza Pessoa, Ary Serpa Neto, Rogerio Ruscitto do Prado, Eliezer Silva, Marcio Dias de Almeida, Thiago Domingos Correa, POCKET Trial Investigators, Leonardo Lima Rocha, Camila Menezes Souza Pessoa, Ary Serpa Neto, Rogerio Ruscitto do Prado, Eliezer Silva, Marcio Dias de Almeida, Thiago Domingos Correa, POCKET Trial Investigators

Abstract

Background: Liver failure patients have traditionally been empirically transfused prior to invasive procedures. Blood transfusion is associated with immunologic and nonimmunologic reactions, increased risk of adverse outcomes and high costs. Scientific evidence supporting empirical transfusion is lacking, and the best approach for blood transfusion prior to invasive procedures in cirrhotic patients has not been established so far. The aim of this study is to compare three transfusion strategies (routine coagulation test-guided - ordinary or restrictive, or thromboelastometry-guided) prior to central venous catheterization in critically ill patients with cirrhosis.

Methods/design: Design and setting: a double-blinded, parallel-group, single-center, randomized controlled clinical trial in a tertiary private hospital in São Paulo, Brazil.

Inclusion criteria: adults (aged 18 years or older) admitted to the intensive care unit with cirrhosis and an indication for central venous line insertion. Patients will be randomly assigned to three groups for blood transfusion strategy prior to central venous catheterization: standard coagulation tests-based, thromboelastometry-based, or restrictive. The primary efficacy endpoint will be the proportion of patients transfused with any blood product prior to central venous catheterization. The primary safety endpoint will be the incidence of major bleeding. Secondary endpoints will be the proportion of transfusion of fresh frozen plasma, platelets and cryoprecipitate; infused volume of blood products; hemoglobin and hematocrit before and after the procedure; intensive care unit and hospital length of stay; 28-day and hospital mortality; incidence of minor bleeding; transfusion-related adverse reactions; and cost analysis.

Discussion: This study will evaluate three strategies to guide blood transfusion prior to central venous line placement in severely ill patients with cirrhosis. We hypothesized that thromboelastometry-based and/or restrictive protocols are safe and would significantly reduce transfusion of blood products in this population, leading to a reduction in costs and transfusion-related adverse reactions. In this manner, this trial will add evidence in favor of reducing empirical transfusion in severely ill patients with coagulopathy.

Trial registration: ClinicalTrials.gov, identifier: NCT02311985 . Retrospectively registered on 3 December 2014.

Keywords: Blood coagulation tests; Blood transfusion; Catheterization; Central venous; Clinical trial; Critical care; Hemostatic disorders; Liver failure; Thromboelastography; Ultrasonography; Vascular access devices.

Figures

Fig. 1
Fig. 1
Coagulogram-based blood transfusion protocol. INR international normalized ratio; aPTT activated thromboplastin time; FFP fresh frozen plasma
Fig. 2
Fig. 2
Thromboelastometry-based blood transfusion protocol. CT clotting time; MCF maximum clot firmness; A10 amplitude at 10 min; FFP fresh frozen plasma
Fig. 3
Fig. 3
Restrictive blood transfusion protocol. INR international normalized ratio; FFP fresh frozen plasma
Fig. 4
Fig. 4
The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) participant timeline in the POCKET trial. ROTEM®, rotational thromboelastometry
Fig. 5
Fig. 5
Study flowchart of the POCKET trial

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