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Thromboelastography in in Patients With Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00994877
First received: September 24, 2009
Last updated: October 13, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition
Shock, Surgical
Systemic Inflammatory Response Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thromboelastography in Patients Admitted to the ICU for Severe Sepsis

Resource links provided by NLM:

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • To determine the common hypercoagulable/ coagulation disorders according to thromboelastography (TEG) [ Time Frame: In hospital ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether TEG results have prognostic implications on this group of severe septic patients [ Time Frame: 28 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
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)
Groups/Cohorts
Septic Patients
Healthy Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients With sepsis or septic shock admitted to ICU

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994877

Contacts
Contact: ASAF MILLER, MD 972-577-346002 asafmiller@gmail.com

Locations
Israel
Asaf Harofeh Medical Center Recruiting
Beer Yaakov, Israel
Contact: asaf miller         asafmiller@gmail.com    
Principal Investigator: ASAF MILLER, MD            
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: asaf miller, md Asaf Harofeh Medical Center
  More Information

Publications:

Responsible Party: ASAF MILLER MD, Assaf Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00994877     History of Changes
Other Study ID Numbers: 34/09
Study First Received: September 24, 2009
Last Updated: October 13, 2009
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Shock, Surgical
Systemic Inflammatory Response Syndrome
Postoperative Complications
 Pathologic Processes
Shock
Inflammation

ClinicalTrials.gov processed this record on May 19, 2013