NCT02971111

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

3.8 years

First QC Date

November 19, 2016

Last Update Submit

September 6, 2018

Conditions

ThrombelastographySepsis

Outcome Measures

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.

    2013 - 2016

Eligibility Criteria

Age24 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients with sepsis who underwent invasive procedures

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28950719DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical researcher

Study Record Dates

First Submitted

November 19, 2016

First Posted

November 22, 2016

Study Start

January 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 10, 2018

Record last verified: 2018-09