NCT03095625

Role of Thromboelastography in Septic Shock

Completed Last updated 25 March 2025

What this trial tests

trial in Sepsis in 50 participants. Completed in 31 December 2017.

Timeline

1 October 2015

Primary endpoint
30 September 2017

31 December 2017

Quick facts

Lead sponsor	University of Turin, Italy
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	1 October 2015
Primary completion	30 September 2017
Estimated completion	31 December 2017
Sites	1 location across Italy

Conditions studied

• Sepsis — all drugs for Sepsis →
• Bleeding Disorder — all drugs for Bleeding Disorder →

Sponsor

University of Turin, Italy

Who can join

18 and older, any sex, with Sepsis or Bleeding Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Coagulation dysfunction is frequent in septic patients and it is associated with an increase risk of mortality. During sepsis platelets number usually decreases and their function is reduced and this mechanism is sustained by an inflammatory induced coagulopathy. Some recent studies evaluated the possibility to use viscoelastic whole blood tests of the haemostasis, such as thromboelastography (TEG), which analyze all blood components and their interactions during clot formation and dissolution and might be useful for assessing bleeding risk in septic patients. Maximun amplitude (MA) is one of the variables obtained from TEG analysis and it expresses the strength of the clot and the efficacy of platelet function. A low level of MA describes a lower strength of the clot determined by a lower number or a reduced function of platelet.

The aim of the present study is to evaluate whether a lower level of MA and a pattern of hypocoagulability might be associated with an increased risk of bleeding and need of transfusion in patients with sepsis.

We want to conduct a prospective multicenter observational study, enrolling 100 consecutive adults patients with sepsis. We will exclude patients under 18 years old of age, chronic use of oral anticoagulant and anti platelet treatment, hematologic malignancy, congenital bleeding disorders, oral contraceptives, lack of consent.

Primary end point To evaluate whether a lower level of MA might be associated with an increased risk of bleeding.

Secondary end points: to evaluate whether a different level of MA correlates with the biomarker of the severity of sepsis such as presepsin, with the biomarker of the severity of infection and whether a pattern of hypocoagulability might be associated with a risk of mortality.

All enrolled patients will undergo a blood sample at admission (T0), after 72 hours (T1) and after 7 days (T2) and all the following parameters will be measured:

Platelet count, APTT, PT, INR, fibrinogen, procalcitonin and presepsin .

Additionally, all viscoelastic parameters (reaction time (R), clot formation speed (K), angle (alpha) and maximum amplitude (MA)) will be performed at bedside, at T0, T1, T2:

Outcome measurements: Intensive Care Unit Length of Stay and mortality at 28 days and at 90 days.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.