Thromboelastography in in Patients With Sepsis | NCT00994877

Studies
Thromboelastography in in Patients With Sepsis

NCT00994877

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Oct 14, 2009Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Shock, Surgical
Systemic Inflammatory Response Syndrome

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

May 2010Estimated

Completion Date

May 2010Estimated

First Submitted Date

Sep 24, 2009

First Submission Date that Met QC Criteria

Oct 13, 2009

First Posted Date

Oct 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2009

Last Update Posted Date

Oct 14, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the common hypercoagulable/ coagulation disorders according to thromboelastography (TEG)		In hospital

Secondary Outcomes

Measure	Description	Time Frame
To determine whether TEG results have prognostic implications on this group of severe septic patients		28 day

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients With sepsis or septic shock admitted to ICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ASAF MILLER, MD	Contact	972-577-346002		asafmiller@gmail.com

Overall Officials

Name	Affiliation	Role
asaf miller, md	Asaf Harofeh Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asaf Harofeh Medical Center	Recruiting	Beer Yaakov			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18784565	Background	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.

Label	Type	Description	Intervention Names
Septic Patients
Healthy Control

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012769	Shock

ID	Term
D012773	Shock, Surgical
D018746	Systemic Inflammatory Response Syndrome