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

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ClinicalTrials.gov Identifier: NCT02311985
Recruitment Status : Terminated (Low inclusion rate)
First Posted : December 9, 2014
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Leonardo Lima Rocha, MD, Hospital Israelita Albert Einstein

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Other: Coagulogram-based protocol Other: Thromboelastometry-based protocol Other: Restrictive strategy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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 Start Date : September 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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.
Other: 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).

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.
Other: 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).

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).
Other: 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).




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Incidence of hemorrhagic complications associated to central venous catheterization procedure [ Time Frame: Day 1 ]
  2. Incidence of acute immunologic and non-immunologic adverse effects of blood transfusion [ Time Frame: Day 1 ]
  3. Costs assessments (laboratory and blood transfusion) between the three strategies [ Time Frame: Day 1 ]
  4. Length of stay in ICU [ Time Frame: Up to 90 days ]
  5. Length of stay in hospital [ Time Frame: Up to 180 days ]
  6. Mortality rate [ Time Frame: Up to 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311985


Locations
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Brazil
Hospital Israelita Albert Einstein
Sao Paulo, SP, Brazil, 05652-900
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Investigators
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Study Chair: Eliezer Silva, MD, PhD Hospital Israelita Albert Einstein
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leonardo Lima Rocha, MD, Adult Critical Care Medicine Attending Physician, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT02311985    
Other Study ID Numbers: 2048-14
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Leonardo Lima Rocha, MD, Hospital Israelita Albert Einstein:
Liver cirrhosis
Blood coagulation
Thromboelastography
Blood transfusion
Catheterization, central venous
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases