NCT02424721

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
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Axis Shield Diagnostics Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Shock, Septic
• Severe Sepsis

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2015-04-23
• Last updated: 2019-01-09

Locations

4 sites across 1 country: Belgium