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CompletedNCT02971111Updated Sep 10, 2018

Thromboelastometry in Assessment of Sepsis Coagulopathy

An observational study in Thrombelastography and Sepsis, sponsored by University Hospital, Motol. Completed. Open to participants aged 24 Years to 89 Years. Per ClinicalTrials.gov, last updated 2018-09-10.

Sponsored by University Hospital, Motol · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
76
Ages
24 Years to 89 Years
Sex
All
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Study summary

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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Conditions studied

  • Thrombelastography
  • Sepsis

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03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 76 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

University Hospital, Motol is the lead sponsor of 45 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
24 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ICU patients with sepsis who underwent invasive procedures

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
76 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. incidence of bleeding complications

    In our group of 76 septic patients who had normal values of EXTEM despite prolonged INR/PR invasive procedures were performed without severe bleeding.

    Time frame: 2013 - 2016

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Lukas P, Durila M, Jonas J, Vymazal T. Evaluation of Thromboelastometry in Sepsis in Correlation With Bleeding During Invasive Procedures. Clin Appl Thromb Hemost. 2018 Sep;24(6):993-997. doi: 10.1177/1076029617731624. Epub 2017 Sep 26. PubMed 28950719 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02971111
Lead sponsor
University Hospital, Motol
Collaborators
Charles University, Czech Republic
Responsible party
Durila Miroslav MUDr. Ph.D. (clinical researcher, University Hospital, Motol) — Principal investigator
First posted
Nov 22, 2016
Start date
Jan 2013
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Sep 10, 2018
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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