Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616001152415
Acronym
BC-TEG
Enrollment
50
Registered
2016-08-24
Start date
2017-05-02
Completion date
2018-04-05
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 t

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.

Sponsors

Intensive Care Unit, Logan Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026