Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2009-03-31
2010-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Septic Patients
No interventions assigned to this group
Healthy Control
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Assaf Harofeh Medical Center
Principal Investigators
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asaf miller, md
Role: PRINCIPAL_INVESTIGATOR
Asaf Harofeh Medical Center
Locations
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Asaf Harofeh Medical Center
Beer Yaakov, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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34/09
Identifier Type: -
Identifier Source: org_study_id
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