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Sepsis Assessment in Belgian Emergency Rooms (SABER)

A

Axis Shield Diagnostics

Status

Terminated

Conditions

Shock, Septic
Severe Sepsis
Sepsis

Study type

Observational

Funder types

Industry

Identifiers

NCT02424721
PEP-FMHBP-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • None

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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