Sepsis Assessment in Belgian Emergency Rooms (SABER)

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

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.

Study Overview

• Status: Terminated
• Conditions: Sepsis; Shock, Septic; Severe Sepsis

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Belgium
  • Anderlecht, Belgium, 1070
    • Clinique St Anne St Remy
  • Brussels, Belgium, 1070
    • Hopital Erasme
  • Charleroi, Belgium, 6000
    • Hopital Civil de Charleroi
  • La Louviere, Belgium, 7100
    • Chu Tivoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the Emergency Department with suspected infection

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Validation of use of HBP in evaluation of patients with suspected infection	12 months

Collaborators and Investigators

• Sponsor: Axis Shield Diagnostics Ltd
• Investigators: Principal Investigator: Jean-Louis Vincent, MD, Erasme University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 15, 2015
• First Submitted That Met QC Criteria: April 20, 2015
• First Posted (Estimate): April 23, 2015

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Shock; Sepsis; Toxemia; Emergencies; Shock, Septic
• Other Study ID Numbers: PEP-FMHBP-003