Thromboelastography in in Patients With Sepsis

• Conditions: Shock, Surgical; Systemic Inflammatory Response Syndrome

• Registration Number: NCT00994877
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

Methods:

The study is an observational prospective trial that includes 150 patients 18 or older admitted to our icu because of severe sepsis or septic shock as defined by the American College of Chest Physicians/ Society of Critical Care Medicine consensus conference.

Patients whose primary reason for hospital admission is sepsis or patients developing sepsis after elective invasive procedure will be included.

Only patients with known former primary coagulation/hypercoagulability disorder wil be excluded.

Procedure:

Within 12 hours of admission to the intensive care unit (ICU) blood will be drawn for the following:

Blood count, glucose, urea, creatinine, liver function tests, prothrombin time, partial thromboplastin time, Ddimer, fibrinogen and TEG (thromboelastography) assay will be performed.

These blood tests will be also drawn on day 2 and 4 of admission. On day one, another 3 cc of blood will be drawn and frozen in -80 degrees for levels of coagulation factors: I, II, V, VII, VIII, IX, X, XI, XII, XIII, Antithrombin III, protein C, S.

Demographic data will be collected according to patient chart, and the acute physiologic and chronic health evaluation (APACHE) II score will be assessed after 24 hours. Vital signs will be collected from monitors.

Informed consent will be waved due to lack of any intervention and the general condition of patients unable to sign an informed consent.

Control group will include 10 healthy individuals.

End point:

The primary end point is to determine the common hypercoagulable/coagulation disorders according to TEG.

The secondary end point is to determine whether TEG results have prognostic implications on this group of severe septic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-09-24
• Status Verified: 2009-10
• Study First Submitted QC: 2009-10-13
• Last Update Submitted: 2009-10-13
• Study First Posted: 2009-10-14
• Last Update Posted: 2009-10-14
• Primary Completion: 2010-05
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients age 18 years or older admitted to ICU whose primary reason for admission was sepsis or suffering sepsis or septic shock after elective surgical procedure

Exclusion Criteria

• Patients suffering primary disease affecting the coagulation system

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the common hypercoagulable/ coagulation disorders according to thromboelastography (TEG)	In hospital

Secondary Outcome Measures

Name	Time	Method
To determine whether TEG results have prognostic implications on this group of severe septic patients	28 day

Trial Locations

Locations (1)

Asaf Harofeh Medical Center; 🇮🇱 Beer Yaakov, Israel