- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02311985
Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial (POCKET)
Point-of-care Versus Standard Coagulation Tests Versus Restrictive Strategy to Guide Transfusion in Chronic Liver Failure Patients Requiring Central Venous Line: Prospective Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
-
Sao Paulo, SP, Brazil, 05652-900
- Hospital Israelita Albert Einstein
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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).
|
Experimental: 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.
|
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).
|
Experimental: 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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients submitted to blood components transfusion - i.e. fresh frozen plasma, platelets and/or cryoprecipitate - before central venous catheterization
Time Frame: Day of randomization
|
Day of randomization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of hemorrhagic complications associated to central venous catheterization procedure
Time Frame: Day 1
|
Day 1
|
Incidence of acute immunologic and non-immunologic adverse effects of blood transfusion
Time Frame: Day 1
|
Day 1
|
Costs assessments (laboratory and blood transfusion) between the three strategies
Time Frame: Day 1
|
Day 1
|
Length of stay in ICU
Time Frame: Up to 90 days
|
Up to 90 days
|
Length of stay in hospital
Time Frame: Up to 180 days
|
Up to 180 days
|
Mortality rate
Time Frame: Up to 28 days
|
Up to 28 days
|
Collaborators and Investigators
Investigators
- Study Chair: Eliezer Silva, MD, PhD, Hospital Israelita Albert Einstein
Publications and helpful links
General Publications
- 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.
- 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.
- 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. Erratum In: N Engl J Med 1999 Apr 1;340(13):1056.
- 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.
- 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.
- 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.
- 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. Erratum In: N Engl J Med. 2013 Jun 13;368(24):2341.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2048-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Cirrhosis
-
Postgraduate Institute of Medical Education and...Society for the Study of Liver Diseases, Chandigarh ( India )UnknownDecompensated Cirrhosis of LiverIndia
-
The Second Affiliated Hospital of Chongqing Medical...RecruitingFibrosis, Liver | Cirrhosis, LiverChina
-
SUUMC Central Military Hospital Dr Carol DavilaRecruiting
-
The Cleveland ClinicRecruiting
-
The Cleveland ClinicRecruitingCirrhosis, LiverUnited States
-
University of PittsburghNational Institute on Drug Abuse (NIDA)CompletedCirrhosis, LiverUnited States
-
Beth Israel Deaconess Medical CenterAmerican Association for the Study of Liver Diseases FoundationCompleted
-
Asian Institute of Gastroenterology, IndiaCompletedCirrhosis, LiverIndia
-
Sherief Abd-ElsalamUnknown
Clinical Trials on Coagulogram-based protocol
-
Universitat Jaume IMinisterio de Economía y Competitividad, SpainUnknown
-
Mohammed RamadanNot yet recruitingSingle Tooth Lost | Partially Edentulous MaxillaEgypt
-
Tel-Aviv Sourasky Medical CenterUnknownLiver Cirrhosis | Coagulopathy
-
Universitat Jaume INot yet recruiting
-
Tulane UniversityXiamen UniversityActive, not recruitingHypertension | Cardiovascular Disease | Diabetes | DyslipidemiaUnited States, China
-
Lawson Health Research InstituteCompletedRespiration, ArtificialCanada
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingSevere Traumatic Brain InjuryPeru, United States, El Salvador, Guatemala, Honduras
-
Universitat Jaume IMinisterio de Economía y Competitividad, SpainCompletedDepression | Anxiety | Emotional DisordersSpain
-
University of California, San DiegoInternational Society of NephrologyCompletedAcute Kidney InjuryBolivia, Malawi, Nepal
-
Université de SherbrookeNot yet recruiting