Role of Thromboelastography in Septic Shock

NCT03095625 | Completed DMC

• 1 other identifier: 0089232
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis; Bleeding Disorder

Keywords

Sepsis; Bleeding disorder; Viscoelastic tests

Outcome Measures

Primary Outcomes (1)

• risk of bleeding

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

  7 days

Secondary Outcomes (2)

• Intensive Care Unit Length of Stay

  28 days

• mortality

  28 days and 90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all adult patients with diagnosis of sepsis admitted to the ICU

You may qualify if:

• all adult patients with diagnosis of sepsis admitted for more than 48 hours will be enrolled

You may not qualify if:

• patients younger than 18 years old of age; chronic use of oral anticoagulant and anti platelet treatment; hematologic malignancy; congenital bleeding disorders; oral contraceptives; lack of consent

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Daniela Pasero

Turin, Piedmont, 10126, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Sepsis; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 29, 2017
• Study Start: October 1, 2015
• Primary Completion: September 30, 2017
• Study Completion: December 31, 2017
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)