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OpenTrials
Completed

NCT Number: NCT02971111

Thromboelastometry in Assessment of Sepsis Coagulopathy

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

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Key information

Conditions

Thrombelastography Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

24 year–89 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Motol

Other

Collaborators

  • Charles University, Czech Republic

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 22, 2016
Registry last updated
Sep 10, 2018

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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