Thromboelastography in in Patients With Sepsis

Thromboelastography in Patients Admitted to the ICU for Severe Sepsis

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.

Study Overview

• Status: Unknown
• Conditions: Systemic Inflammatory Response Syndrome; Shock, Surgical

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: ASAF MILLER, MD; Phone Number: 972-577-346002; Email: asafmiller@gmail.com

Study Locations

• Israel
  • Beer Yaakov, Israel
    • Recruiting
    • Asaf Harofeh Medical Center
    • Contact: asaf miller; Email: asafmiller@gmail.com
    • Principal Investigator: ASAF MILLER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients With sepsis or septic shock admitted to ICU

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Control
Septic Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the common hypercoagulable/ coagulation disorders according to thromboelastography (TEG)	In hospital

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine whether TEG results have prognostic implications on this group of severe septic patients	28 day

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: asaf miller, md, Asaf Harofeh Medical Center

Publications and helpful links

General Publications

• Martini WZ, Cortez DS, Dubick MA, Park MS, Holcomb JB. Thrombelastography is better than PT, aPTT, and activated clotting time in detecting clinically relevant clotting abnormalities after hypothermia, hemorrhagic shock and resuscitation in pigs. J Trauma. 2008 Sep;65(3):535-43. doi: 10.1097/TA.0b013e31818379a6.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): May 1, 2010
• Study Completion (Anticipated): May 1, 2010

Study Registration Dates

• First Submitted: September 24, 2009
• First Submitted That Met QC Criteria: October 13, 2009
• First Posted (Estimate): October 14, 2009

Study Record Updates

• Last Update Posted (Estimate): October 14, 2009
• Last Update Submitted That Met QC Criteria: October 13, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Postoperative Complications; Shock; Systemic Inflammatory Response Syndrome; Shock, Surgical
• Other Study ID Numbers: 34/09