Thromboelastography in in Patients With Sepsis

NCT00994877 | Unknown

• 1 other identifier: 34/09
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• To determine the common hypercoagulable/ coagulation disorders according to thromboelastography (TEG)

  In hospital

Secondary Outcomes (1)

• To determine whether TEG results have prognostic implications on this group of severe septic patients

  28 day

Study Arms (2)

Septic Patients

Healthy Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients With sepsis or septic shock admitted to ICU

You may qualify if:

• 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

You may not qualify if:

• Patients suffering primary disease affecting the coagulation system

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Asaf Harofeh Medical Center

Beer Yaakov, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 18784565 BACKGROUND

MeSH Terms

Conditions

Shock, Surgical; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Inflammation

Study Officials

• asaf miller, md

  Asaf Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ASAF MILLER, MD

CONTACT

972-577-346002; asafmiller@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: October 14, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 14, 2009

Record last verified: 2009-10

Locations

IL (1)