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

NCT02311985 | Terminated

• 1 other identifier: 2048-14
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Keywords

Liver cirrhosis; Blood coagulation; Thromboelastography; Blood transfusion; Catheterization, central venous

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 ICU

  Up to 90 days

• Length of stay in hospital

  Up to 180 days

Study Arms (3)

Coagulogram-based protocol

ACTIVE COMPARATOR

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.

Other: Coagulogram-based protocol

Thromboelastometry-based protocol

EXPERIMENTAL

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.

Other: Thromboelastometry-based protocol

Restrictive strategy

EXPERIMENTAL

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).

Other: Restrictive strategy

Interventions

Coagulogram-based protocol OTHER

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).

Coagulogram-based protocol

Thromboelastometry-based protocol OTHER

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).

Thromboelastometry-based protocol

Restrictive strategy OTHER

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).

Restrictive strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic liver failure (cirrhosis or chronic graft dysfunction) from any cause and medical indication of central venous line placement

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652-900, Brazil

Location

Related Publications (14)

• 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.

  PMID: 12646670 BACKGROUND

• 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.

  PMID: 17482407 BACKGROUND

• 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.

  PMID: 21751907 BACKGROUND

• Stravitz RT. Potential applications of thromboelastography in patients with acute and chronic liver disease. Gastroenterol Hepatol (N Y). 2012 Aug;8(8):513-20.

  PMID: 23293564 BACKGROUND

• 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.

  PMID: 16131373 BACKGROUND

• 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.

  PMID: 21375741 BACKGROUND

• 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.

  PMID: 21062383 BACKGROUND

• 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.

  PMID: 21466676 BACKGROUND

• 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.

  PMID: 9971864 BACKGROUND

• 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.

  PMID: 20940381 BACKGROUND

• 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.

  PMID: 22168590 BACKGROUND

• 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.

  PMID: 23281973 BACKGROUND

• 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.

  PMID: 31667992 DERIVED

• 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.

  PMID: 28241780 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Thrombosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eliezer Silva, MD, PhD

  Hospital Israelita Albert Einstein

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adult Critical Care Medicine Attending Physician

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 9, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

BR (1)