Thromboelastometry in Assessment of Sepsis Coagulopathy

September 6, 2018 updated by: Durila Miroslav MUDr. Ph.D., University Hospital, Motol

Evaluation of Thromboelastometry in Sepsis in Correlation to Bleeding During Invasive Procedures

The purpose of this study is to analyze occurence of bleeding complications during invasive procedures in septic patients with normal tromboelastometry results despite prolonged standard coagulation tests results

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

76

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 89 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICU patients with sepsis who underwent invasive procedures

Description

Inclusion Criteria:

  • sepsis/septic shock
  • prolonged PT-INR (international normalized ratio) ≥ 1.3
  • normal ROTEM-EXTEM results.

Exclusion Criteria:

  • patients on antiplatelet drugs or anticoagulant therapy (heparin, vitamin K antagonists…)
  • patients with cirrhosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of bleeding complications
Time Frame: 2013 - 2016
In our group of 76 septic patients who had normal values of EXTEM despite prolonged INR/PR invasive procedures were performed without severe bleeding.
2013 - 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Motol

Collaborators

Charles University, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

November 19, 2016

First Submitted That Met QC Criteria

November 19, 2016

First Posted (ESTIMATE)

November 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1318514

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.

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