ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12616001152415

Ethics application status

Approved

Date submitted

14/08/2016

Date registered

24/08/2016

Date last updated

8/04/2022

Date data sharing statement initially provided

8/04/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

A Prospective observational trial to assess if thromboelastography (TEG) can be used to predict blood culture results in clinically septic patients.

Scientific title

A Prospective observational trial to assess if thromboelastography (TEG) can be used to predict blood culture results in clinically septic patients

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

BC-TEG

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sepsis

coagulation

Condition category

Condition code

Infection

Other infectious diseases

Blood

Clotting disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Patients admitted to intensive care who fulfil Systemic Inflammatory Response Syndrome (SIRS) criteria and are clinically thought to have sepsis will have a sample of blood taken to perform a thromboelastogram (TEG) both at admission and on discharge. These results will be correlated with blood culture results from samples that have been taken at clinically appropriate times - no additional blood culture samples will be taken. The patient will not be clinically followed up after discharge for the purposes of this study.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To determine whether the TEG results from patients who are admitted to the ICU with clinically diagnosed sepsis (using SIRS criteria and clinical suspicion of an infectious source) are correlated to obtaining a positive blood culture result.

Timepoint [1]

The blood samples will be taken on admission to ICU.

Secondary outcome [1]

To determine if standard laboratory coagulation studies correlate with the TEG changes in culture positive sepsis

Timepoint [1]

Results from the routine blood tests taken on admission to ICU will be compared to blood samples taken for TEG at admission

Secondary outcome [2]

To determine if TEG changes on discharge from the ICU have resolved with clinical improvement

Timepoint [2]

Blood sample will be taken on discharge from ICU

Secondary outcome [3]

Diagnosis on admission to hospital, by review of hospital records

Timepoint [3]

At time of admissin

Secondary outcome [4]

Diagnosis on admission to ICU, by review of hospital records

Timepoint [4]

At time of admission

Secondary outcome [5]

Length of stay in the ICU, by review of hospital records

Timepoint [5]

At time of ICU discharge

Secondary outcome [6]

Source of sepsis, by review of hospital records

Timepoint [6]

At time of ICU discharge

Secondary outcome [7]

Use of vasoactive drugs, by review of hospital records

Timepoint [7]

At time of ICU discharge

Secondary outcome [8]

Hospital mortality, by review of hospital records

Timepoint [8]

At time of hospital discharge or death

Eligibility

Key inclusion criteria

Patients admitted to ICU who;
- are aged >18 years
- Have SIRS; 2 of the following criteria on admission;
- Temperature >38 or <36
- Pulse rate >90/minute
- Respiratory rate >20/minute or PaCo2 <32mmHg
- White cell count >12 or >10% immature bands
- Clinical diagnosis of sepsis

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Pre-existing diagnosis of a coagulation disorder
- On anticoagulant treatment eg heparin infusion, treatment dose low-molecular weight heparin, warfarin or oral anticoagulants

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

31/08/2016

Actual

2/05/2017

Date of last participant enrolment

Anticipated

31/07/2017

Actual

5/04/2018

Date of last data collection

Anticipated

31/08/2017

Actual

5/04/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Logan Hospital - Meadowbrook

Recruitment postcode(s) [1]

4131 - Meadowbrook

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Logan Hospital Intensive Care Unit

Address [1]

Logan Hospital
Cnr Armstrong and Loganlea Roads
Meadowbrook
QLD
4131

Country [1]

Australia

Primary sponsor type

Hospital

Name

Intensive Care Unit, Logan Hospital

Address

Cnr Armstrong and Loganlea Rds
Meadowbrook
QLD
4131

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

Princess Alexandra hospital
199 Ipswich Road
Woolloongabba 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/08/2016

Approval date [1]

10/01/2017

Ethics approval number [1]

Summary

Brief summary

This study will examine if there are changes in coagulation which can be detected by TEG that occur in patients with a bacteraemia before it has been detected in blood cultures.  
The benefits of being aware of these potential changes may include earlier consideration of non-infective causes of SIRS and altered antibiotic prescribing practices.  In contrast, early identification of a potentially life-threatening infective process that is responsible for the SIRS presentation is essential to ensure ‘ideal outcomes’ for patients (1). It is a common and important clinical challenge to distinguish between those patients who have sepsis and those who have SIRS.  A hypocoagulable state in sepsis is thought to be associated with increased mortality. Specifically, impaired fibrinolysis may be associated with a diagnosis of sepsis versus SIRS (2).  
On admission to ICU, patients generally have a set of routine admission bloods sampled; these may include full blood count, electrolytes, renal and hepatic function and a coagulation profile.  Routine blood tests may also include blood cultures if the patient is thought to be septic.  However, the routine coagulation profile sent to pathology is thought to provide limited clinical information when assessing in vivo hypocoaguable changes (2).  Research has demonstrated that TEG parameter changes throughout an episode of sepsis may provide some predictive value for mortality and risk of bleeding (3). Recent research has aimed to identify early TEG parameters that may predict a positive blood culture result (4).  
The aim of our study is to identify blood changes detected by TEG that may indicate whether a patient has sepsis or a non-infective cause for SIRS.
References;
1.	Simpson S. New Sepsis Criteria; A change we should not make. Chest. 2016; 149(5).
2.	Muller MC, Meijers JCM, Vroom MB, Juffermans NP. Utility of thromboelastography and/or thromboelastometry in adults with sepsis: a systematic review. Critical care (London, England). 2014; 18(1):R30-R.
3.	Haase N, Ostrowski SR, Wetterslev J, Lange T, Moller MH, Tousi H, et al. Thromboelastography in patients with severe sepsis: a prospective cohort study. Intensive Care Medicine. 2015; 41(1):77-85.
4.	Grant HW, Hadley GP. Prediction of neonatal sepsis by thromboelastography. Pediatric Surgery International. 1997; 12(4):289-92.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Hayden White

Address

Director of Intensive Care
Logan Hospital
Cnr Armstrong and Loganlea Roads
Meadowbrook 4131
QLD

Country

Australia

Phone

+61 7 3299 8755

Fax

+61 7 3299 8376

Hayden.White@health.qld.gov.au

Contact person for public queries

Name

Hayden White

Address

Director of Intensive Care
Logan Hospital
Cnr Armstrong and Loganlea Roads
Meadowbrook 4131
QLD

Country

Australia

Phone

+61 7 3299 8755

Fax

+61 7 3299 8376

Hayden.White@health.qld.gov.au

Contact person for scientific queries

Name

Hayden White

Address

Director of Intensive Care
Logan Hospital
Cnr Armstrong and Loganlea Roads
Meadowbrook 4131
QLD

Country

Australia

Phone

+61 7 3299 8755

Fax

+ 61 7 3299 8376

Hayden.White@health.qld.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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