Help in the Emergency Room to Detect Organ Dysfunction
HERO
1 other identifier
observational
600
3 countries
4
Brief Summary
The purpose of this prospective, non-interventional clinical study is to assess the clinical validity of a number of markers (including Heparin Binding Protein (HBP), Procalcitonin (PCT), C-reactive protein (CRP), White cell count (WCC) and lactate) for indicating the presence of organ dysfunction, or outcome, of patients with organ dysfunctions following emergency department admission or hospitalization. Secondary objectives are to identify novel putative biomarkers and to identify risk factors for negative long-term effects of acute critical illness The HBP assay is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Heparin Binding Protein in human plasma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 12, 2015
CompletedFirst Posted
Study publicly available on registry
February 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedOctober 21, 2015
October 1, 2015
1.1 years
February 12, 2015
October 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
infection-induced organ dysfunction
To evaluate the presence or development of infection-induced organ dysfunction within a 72 hour time period from enrolment at the Emergency Department.
72 hours
Secondary Outcomes (7)
To compare the specificity, sensitivity and accuracy of HBP against other biochemical markers
72 hours
To investigate the specificity, sensitivity and accuracy in biochemical markers to predict mortality, ICU-care, days in hospital and the persistence of organ dysfunction.
90 days
To investigate and identify risk factors for a negative long-term (5-10 year) outcome.
10 years
• Organ dysfunction 24-36 and 72 hours after arriving at the hospital
72 hrs
• Primary diagnosis infection (y/n)
72 hrs
- +2 more secondary outcomes
Study Arms (4)
Lund ED
appr 100-200 patients at Lund ED
Helsingborg ED
appr 100-200 patients at Helsingborg ED
Vancouver ED
appr 100 patients at St Paul's hospital ED
Bern ED
appr 100 patients at Bern ED
Eligibility Criteria
Subject enrolment will be based on adult patients presenting to the emergency department at the different sites with suspicion of organ dysfunction or identified at the hospital wars/units.
You may qualify if:
- i) ≥18 years of age ii) 1 or more of the following criteria: Saturation\<90% without oxygen or \<93% with oxygen or reported saturation\<90%, Respiratory frequency \>25/min, Altered mental awareness, Heart rate \>120/min, Systolic blood pressure \<100 mm Hg. iv) informed consent.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (4)
John Boyd
Vancouver, Canada
Helsingborg
Helsingborg, Sweden
Lund ED
Lund, Sweden
Bern ED
Bern, Switzerland
Biospecimen
Plasma and blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,PhD
Study Record Dates
First Submitted
February 12, 2015
First Posted
February 19, 2015
Study Start
February 1, 2015
Primary Completion
March 1, 2016
Study Completion
August 1, 2016
Last Updated
October 21, 2015
Record last verified: 2015-10