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Thromboelastography in in Patients With Sepsis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00994877
First Posted: October 14, 2009
Last Update Posted: October 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  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:


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 ]

Secondary Outcome Measures:
  • To determine whether TEG results have prognostic implications on this group of severe septic patients [ Time Frame: 28 day ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 24, 2009
First Posted: October 14, 2009
Last Update Posted: October 14, 2009
Last Verified: October 2009

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