Thromboelastography in in Patients With Sepsis
Recruitment status was: Recruiting
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.
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.
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.
Systemic Inflammatory Response Syndrome
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Thromboelastography in Patients Admitted to the ICU for Severe Sepsis|
- To determine the common hypercoagulable/ coagulation disorders according to thromboelastography (TEG) [ Time Frame: In hospital ] [ Designated as safety issue: No ]
- To determine whether TEG results have prognostic implications on this group of severe septic patients [ Time Frame: 28 day ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||May 2010|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994877
|Asaf Harofeh Medical Center|
|Beer Yaakov, Israel|
|Principal Investigator:||asaf miller, md||Asaf Harofeh Medical Center|