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Sepsis Assessment in Belgian Emergency Rooms

Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein Assay to Assist in Evaluation of Patients With Suspected Infection Following Emergency Department Admission

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02424721
Acronym
SABER
Enrollment
100
Registered
2015-04-23
Start date
2015-05-31
Completion date
2018-12-31
Last updated
2019-01-09

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

Conditions

Sepsis, Severe Sepsis, Shock, Septic

Brief summary

To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.

Detailed description

Prospective, non-interventional, multi-centre clinical study to assess the clinical validity of the Heparin Binding Protein (HBP) assay to assist in evaluation of patients with suspected infection following emergency department admission. Patients presenting to the emergency department with suspected infection will be enrolled to the study and have a blood sample taken. The patients clinical data over a 72 hour period after enrolment will be recorded in the CRF. The enrolment sample will then be retrospectively measured for the HBP level and the power of the enrolment HBP level to predict subsequent clinical development over the following 72 hours will be assessed. Data analysis shall include Area Under Curve (AUC) from Receiver Operating Characteristics (ROC) plot against the patient's final clinical diagnosis as well as sensitivity and specificity of the HBP level to predict the final clinical outcome.

Interventions

None listed

Sponsors

Axis Shield Diagnostics Ltd
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* \>18 years of age, * Suspected infection (temperature \>38C or clinical evidence of infection), * intention by clinician to start antibiotics

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Validation of use of HBP in evaluation of patients with suspected infection12 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026