Thromboelastometry in Assessment of Sepsis Coagulopathy

Completed

• Conditions: Thrombelastography; Sepsis

• Registration Number: NCT02971111
• Lead Sponsor: University Hospital, Motol

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2016-11-19
• Study First Submitted QC: 2016-11-19
• Study First Posted: 2016-11-22
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of bleeding complications	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.