Thromboelastometry in Assessment of Sepsis Coagulopathy

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971111
• Other study ID #: 1318514
• Status: Completed
• Start date: January 2013
• Est. completion date: October 2016

Study information

• Verified date: September 2018
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Thrombelastography
• Toxemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Motol	Charles University, Czech Republic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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