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
| Autor: | Leonardo Lima Rocha, Marcio Dias de Almeida, Camila Menezes Souza Pessoa, Rogerio Ruscitto do Prado, Thiago Domingos Corrêa, Ary Serpa Neto, Eliezer Silva |
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| Jazyk: | angličtina |
| Předmět: |
Liver Cirrhosis
Blood transfusion Time Factors medicine.medical_treatment Cost-Benefit Analysis Medicine (miscellaneous) 030204 cardiovascular system & hematology Hematocrit Central venous Tertiary Care Centers Study Protocol 0302 clinical medicine Clinical Protocols Blood product Risk Factors Coagulation testing Pharmacology (medical) 030212 general & internal medicine Hospital Mortality Hospital Costs Hemostatic disorders Blood coagulation test Ultrasonography medicine.diagnostic_test Thrombelastography Clinical trial Thromboelastometry Treatment Outcome Research Design Vascular access devices Fresh frozen plasma Blood Coagulation Tests Brazil medicine.medical_specialty Catheterization Central Venous Critical Illness Catheterization Hospitals Private 03 medical and health sciences Double-Blind Method Predictive Value of Tests Thromboelastography medicine Humans Blood Transfusion Intensive care medicine Blood Coagulation business.industry Liver failure Transfusion Reaction Length of Stay Critical care Cryoprecipitate business |
| Zdroj: | Trials |
| ISSN: | 1745-6215 |
| DOI: | 10.1186/s13063-017-1835-5 |
| Popis: | 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. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1835-5) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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