Thromboelastography in in Patients With Sepsis

Systemic Inflammatory Response Syndrome Clinical Trial

Official title:

Thromboelastography in Patients Admitted to the ICU for Severe Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00994877
• Other study ID #: 34/09
• Status: Recruiting
• Phase: N/A
• First received: September 24, 2009
• Last updated: October 13, 2009
• Start date: March 2009
• Est. completion date: May 2010

Study information

• Verified date: October 2009
• Source: Assaf-Harofeh Medical Center
• Contact: ASAF MILLER, MD
• Phone: 972-577-346002
• Email: asafmiller[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Shock, Surgical
• Systemic Inflammatory Response Syndrome

Locations

Country	Name	City	State
Israel	Asaf Harofeh Medical Center	Beer Yaakov

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the common hypercoagulable/ coagulation disorders according to thromboelastography (TEG)		In hospital	No
Secondary	To determine whether TEG results have prognostic implications on this group of severe septic patients		28 day	No