Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial
NCT ID: NCT02311985
Last Updated: 2018-03-07
Study Results
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Basic Information
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TERMINATED
NA
57 participants
INTERVENTIONAL
2014-09-30
2016-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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).
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.
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).
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).
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).
Interventions
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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).
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).
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hospital Israelita Albert Einstein
OTHER
Responsible Party
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Leonardo Lima Rocha, MD
Adult Critical Care Medicine Attending Physician
Principal Investigators
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Eliezer Silva, MD, PhD
Role: STUDY_CHAIR
Hospital Israelita Albert Einstein
Locations
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Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Countries
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References
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McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. doi: 10.1056/NEJMra011883. No abstract available.
Tercan F, Ozkan U, Oguzkurt L. US-guided placement of central vein catheters in patients with disorders of hemostasis. Eur J Radiol. 2008 Feb;65(2):253-6. doi: 10.1016/j.ejrad.2007.04.002. Epub 2007 May 4.
Tripodi A, Mannucci PM. The coagulopathy of chronic liver disease. N Engl J Med. 2011 Jul 14;365(2):147-56. doi: 10.1056/NEJMra1011170. No abstract available.
Stravitz RT. Potential applications of thromboelastography in patients with acute and chronic liver disease. Gastroenterol Hepatol (N Y). 2012 Aug;8(8):513-20.
Segal JB, Dzik WH; Transfusion Medicine/Hemostasis Clinical Trials Network. Paucity of studies to support that abnormal coagulation test results predict bleeding in the setting of invasive procedures: an evidence-based review. Transfusion. 2005 Sep;45(9):1413-25. doi: 10.1111/j.1537-2995.2005.00546.x.
Schochl H, Nienaber U, Maegele M, Hochleitner G, Primavesi F, Steitz B, Arndt C, Hanke A, Voelckel W, Solomon C. Transfusion in trauma: thromboelastometry-guided coagulation factor concentrate-based therapy versus standard fresh frozen plasma-based therapy. Crit Care. 2011;15(2):R83. doi: 10.1186/cc10078. Epub 2011 Mar 4.
Watson DM, Stanworth SJ, Wyncoll D, McAuley DF, Perkins GD, Young D, Biggin KJ, Walsh TS. A national clinical scenario-based survey of clinicians' attitudes towards fresh frozen plasma transfusion for critically ill patients. Transfus Med. 2011 Apr;21(2):124-9. doi: 10.1111/j.1365-3148.2010.01049.x. Epub 2010 Nov 10.
Stanworth SJ, Walsh TS, Prescott RJ, Lee RJ, Watson DM, Wyncoll D; Intensive Care Study of Coagulopathy (ISOC) investigators. A national study of plasma use in critical care: clinical indications, dose and effect on prothrombin time. Crit Care. 2011;15(2):R108. doi: 10.1186/cc10129. Epub 2011 Apr 5.
Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/NEJM199902113400601.
Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leao WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446.
Carson JL, Terrin ML, Noveck H, Sanders DW, Chaitman BR, Rhoads GG, Nemo G, Dragert K, Beaupre L, Hildebrand K, Macaulay W, Lewis C, Cook DR, Dobbin G, Zakriya KJ, Apple FS, Horney RA, Magaziner J; FOCUS Investigators. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med. 2011 Dec 29;365(26):2453-62. doi: 10.1056/NEJMoa1012452. Epub 2011 Dec 14.
Villanueva C, Colomo A, Bosch A, Concepcion M, Hernandez-Gea V, Aracil C, Graupera I, Poca M, Alvarez-Urturi C, Gordillo J, Guarner-Argente C, Santalo M, Muniz E, Guarner C. Transfusion strategies for acute upper gastrointestinal bleeding. N Engl J Med. 2013 Jan 3;368(1):11-21. doi: 10.1056/NEJMoa1211801.
Rocha LL, Neto AS, Pessoa CMS, Almeida MD, Juffermans NP, Crochemore T, Rodrigues RR, Filho RR, de Freitas Chaves RC, Cavalheiro AM, Prado RR, Assuncao MSC, Guardia BD, Silva E, Correa TD. Comparison of three transfusion protocols prior to central venous catheterization in patients with cirrhosis: A randomized controlled trial. J Thromb Haemost. 2020 Mar;18(3):560-570. doi: 10.1111/jth.14672. Epub 2019 Dec 2.
Rocha LL, Pessoa CM, Neto AS, do Prado RR, Silva E, de Almeida MD, Correa TD; POCKET Trial Investigators. 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. Trials. 2017 Feb 27;18(1):85. doi: 10.1186/s13063-017-1835-5.
Other Identifiers
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2048-14
Identifier Type: -
Identifier Source: org_study_id
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