MedTrace Logo

Thromboelastography in in Patients With Sepsis

NCT00994877 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2009-10-14

No results posted yet for this study

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.

Conditions

  • Shock, Surgical
  • Systemic Inflammatory Response Syndrome

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Principal Investigators

  • asaf miller, md · Asaf Harofeh Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Israel

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00994877 on ClinicalTrials.gov