NCT03113721

Assessment of Heparin Binding Protein for the Prediction of Severe Sepsis

Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the HBP Assay to Predict Development of Severe Sepsis in Patients With Suspected Infection Following ED Admission

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 571 (actual)
• Sponsor: Axis Shield Diagnostics Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this prospective, non-interventional, multi-centre clinical study is to assess the clinical validity of the Heparin Binding Protein (HBP) assay for indicating the presence, or outcome, of severe sepsis (including septic shock), over 72 hours, in patients with suspected infection following emergency department admission.

Detailed description

The primary objective of this study is to use HBP concentration to indicate the presence, or outcome, of severe sepsis (including septic shock) at admission and to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission. The secondary objectives of this study are to separately evaluate the performance of HBP concentration to a) indicate the presence of severe sepsis (including severe sepsis) at admission and b) to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission. Further exploratory objectives include evaluating the use of HBP measurement to indicate the outcome of severe sepsis (including septic shock) in patients with suspected infection 12-24 hours after emergency department admission, to compare the use of HBP to other markers of severe infection and to evaluate whether or not different cut-off values are required for the progression and outcome measures.

Conditions

• Sepsis
• Septic Shock
• Sepsis With Acute Organ Dysfunction

Timeline

• Start date: 2017-03-27
• Primary completion: 2018-12-31
• Completion: 2019-03-01
• First posted: 2017-04-13
• Last updated: 2019-01-09

Locations

5 sites across 1 country: United States