DetectIon of Severe Sepsis In PATients With Neurological haemorrhagE (The DISSIPATE Study)

National University Health System (NUHS)

Status: Enrolling

Conditions: Hemorrhage Brain; Sepsis

Treatments: Diagnostic Test: APTT CWA (Activated partial thromboplastin time clot waveform analysis), Procalcitonin and Serological/Inflammatory markers (KL-6, SPA, MIG, Presepsin)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04624945

2020/00020

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

SICU cohort

Description:

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. Frequency of blood sampling will be stipulated atday 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.

Treatment:

Diagnostic Test: APTT CWA (Activated partial thromboplastin time clot waveform analysis), Procalcitonin and Serological/Inflammatory markers (KL-6, SPA, MIG, Presepsin)