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Completed

NCT Number: NCT02362178

Thromboelastographic Guide for Blood Products in Cirrhotics

Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests (namely INR and PLTs count) are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Thromboelastography (TEG) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study was to evaluate the efficacy of TEG as a guide for blood products transfusion in cirrhotic patients undergoing invasive procedures.

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Key information

Conditions

Liver Cirrhosis Cardiovascular Diseases Coagulation Disorder Digestive System Diseases Fibrosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologic or imaging-proven liver cirrhosis of any etiology
  • INR>1.8 and/or PLTs count <50x103/μl

Exclusion criteria

  • Ongoing bleeding
  • Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel
  • Ongoing antiplatelet or anticoagulant therapy or stopped less than 7 days before evaluation for the study
  • Presence of sepsis according to ACP-SCCP criteria
  • Hemodialysis performed within 7 days

Treatment and study plan

Thromboelastography to guide blood products infusion

Procedure

A TEG has been performed before invasive procedure and blood products infusion has been decided according to TEG parameters as follow: fresh frozen plasma (FFP 10 ml/kg) in case of r time>40 mm and/or platelets (PLTs 10 units/Kg) for MA<30 mm

Standard of care coagulation tests to guide blood products infusion

Procedure

Patients received FFP (10 ml/kg) if INR>1.8 and/or PLTS (10 units/Kg) If PLTs count < 50000/μl

Primary outcomes

  1. Comparison in the amount of blood products transfused between the groups

    Time frame: 48 hours from admission

    Comparison of the number of patients receiving blood products (FFPor PLTs or both), and the amount of blood products between the study groups

Secondary outcomes

  1. Post-procedure bleeding

    Time frame: 48 hours from admission

    Comparison of the number of patients having bleeding episodes after procedure between the study groups

  2. Survival

    Time frame: 90 days patient survival

    Comparison of patients survival between the study groups

  3. Transfusion related side effects

    Time frame: 48 hours from admission

    Comparison of the number of patients presenting transfusion side effects between the study groups

  4. Procedure-related complications

    Time frame: during hospitalization (mean 4 weeks)

    Comparison of the number of patients presenting post-procedures complication other than bleeding between the study groups

  5. Comparison between blood products costs between groups

    Time frame: 48 hours from admission

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Registry information

Official study title

USE OF THROMBOELASTOGRAPHY TO GUIDE BLOOD PRODUCTS REPLACEMENT IN DECOMPENSATED CIRRHOTIC PATIENTS UNDERGOING INVASIVE PROCEDURES

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 12, 2015
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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