Hemorrhage Brain, Sepsis
Conditions
Keywords
Severe sepsis in patients with neurological haemorrhage
Brief summary
The research study is to explore novel early predictors and validation of laboratory parameters in the management of sepsis in critically ill patients especially with brain injuries and systemic inflammatory response syndrome (SIRS).
Detailed description
This is a prospective observational study. 150 subjects with the admission diagnosis of neurological haemorrhage (e.g. subarachnoid haemorrhage, intracerebral haemorrhage etc), admitted to SICU of National University Hospital, Singapore, who are expected to stay for more than 48 hours, will be recruited and enrolled. No adverse events are expected as a result of this study as patients do not deviate from the current standard of care. Frequency of blood sampling will be stipulated at day 1/2/3/4/5 to draw clinical relevance. An additional 0.5 tablespoonful (7.7ml) of blood will be taken daily from each subject as well as residual blood from routine laboratory test blood samples. In total, an additional volume of 2.5 tablespoonful (38.5ml) of blood will be collected from each subject over a period of 5 days. Residual blood refers to any leftover blood samples collected for routine laboratory tests which will be shared and used to carry out additional blood tests. All ICU patients will have arterial lines inserted as part of routine care, so there will not be pain from the blood sampling. In the current study, measurements will be made on the routine laboratory haematology, coagulation and immunoassay analyzers. Research blood parameters that are not usually reported as indicated in the background section will be used for the correlation and association analysis to sepsis. In addition, the study team will also be collecting clinical and demographic data of recruited subjects from medical records for purposes of this study.
Interventions
DIAGNOSTIC_TESTAPTT CWA (Activated partial thromboplastin time clot waveform analysis), Procalcitonin and Serological/Inflammatory markers (KL-6, SPA, MIG, Presepsin)
Primary Aim: To validate the use of APTT CWA (Activated partial thromboplastin time clot waveform analysis) and ICIS (Intensive Care Infection Score), as early sepsis markers for neurosurgical ICU patients suffering subarachnoid haemorrhage, traumatic brain injury and other intracranial haemorrhages. Secondary Aim: To examine the evolution of CWA, immuno-parameters (KL-6, SP-A, MIG, presepsin) and various WBC (white blood cell count) activation markers over the time in relation to diagnosis of sepsis, development of positive blood cultures and mortality or recovery. Blood parameter measurements using a 3-part and 5-part differential analyser will be performed. KL-6, SP-A, MIG, presepsin are serum biomarkers - MIG (Monokine induced by gamma interferon), SP-A (Surfactant protein A), KL-6 (Krebs von den Lungen 6).
Sponsors
Sysmex Asia Pacific
National University Hospital, Singapore
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Adults 21 years and above * Clinical/radiological suspicion or confirmation of neurological haemorrhage
Exclusion criteria
* Age below 21 years * Prisoners * Known pregnancy * Do-not-attempt resuscitation status * Requirement for immediate surgery * Active chemotherapy/neutropenia (Neutrophil count \<1.0 x 109/L) * Immuno-compromised * Haematological malignancy * Treating physician deems aggressive care unsuitable * Unable to provide informed consent or comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To validate the use of APTT CWA and ICIS, as early sepsis markers for neurosurgical ICU patients suffering subarachnoid haemorrhage, traumatic brain injury and other intracranial haemorrhages. | SICU stay from day 1 to day 5 through to 2 years of blood test completion | Activated Partial Thromboplastin Time (APTT) clot waveform analysis (CWA) by flow cytometry-based method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To examine the evolution of CWA, immuno-parameters (KL-6, SP-A, MIG, presepsin) and various WBC activation markers over the time in relation to diagnosis of sepsis, development of positive blood cultures and mortality or recovery. | SICU stay from day 1 to day 5 through to 2 years of blood test completion | Blood parameter measurements using a 3-part and 5-part differential analyser will be performed. |
Countries
Singapore
Contacts
Primary ContactWill NH Loh, MBBS
Backup ContactChristina YC Yip, PhD
Outcome results
None listed