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Thromboelastographic Guide for Blood Products in Cirrhotics

NCT02362178 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-02-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Thromboelastography to guide blood products infusion

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

PROCEDURE

Standard of care coagulation tests to guide blood products infusion

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

Sponsors & Collaborators

  • University of Modena and Reggio Emilia

    lead OTHER

Principal Investigators

  • Lesley De pietri, MD · Azienda Ospedaliero-Universitaria di Modena-Policlinico, Division of Anaesthesiology and Intensive Care Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-08-31
Completion
2014-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02362178 on ClinicalTrials.gov