NCT01392508

Brief Summary

The purposes of this study is to determine whether Heparin Binding Protein (HBP) can be used as a marker of severe sepsis (including septic shock) in patients presenting to the emergency department with suspected infection.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
759

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

4.5 years

First QC Date

July 11, 2011

Last Update Submit

April 13, 2017

Conditions

Systemic Inflammatory Response Syndrome (SIRS)SepsisSevere SepsisSeptic Shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting to emergency department with suspected infection

You may qualify if:

  • Greater than or equal to 18 years
  • Suspected Infection
  • one or more SIRS criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cooper University Hospital

Camden, New Jersey, United States

Location

Universitetssjukhuset i Linkoping

Linköping, Sweden

Location

Skanes Universitetssjukhus i Lund

Lund, Sweden

Location

Skanes Universitetssjukhuset i Malmo

Malmo, Sweden

Location

Universitetssjukhuset i Orebro

Örebro, Sweden

Location

Related Publications (1)

  • Linder A, Arnold R, Boyd JH, Zindovic M, Zindovic I, Lange A, Paulsson M, Nyberg P, Russell JA, Pritchard D, Christensson B, Akesson P. Heparin-Binding Protein Measurement Improves the Prediction of Severe Infection With Organ Dysfunction in the Emergency Department. Crit Care Med. 2015 Nov;43(11):2378-86. doi: 10.1097/CCM.0000000000001265.

    PMID: 26468696RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Plasma (LiHep and citrate)

MeSH Terms

Conditions

Systemic Inflammatory Response SyndromeSepsisShock, Septic

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockInfections

Study Officials

  • Adam Linder

    Skanes Universitetssjukhus I Lund, Sweden

    PRINCIPAL INVESTIGATOR

  • Magnus Paulsson

    Skanes universitetssjukhuset i Malmo

    PRINCIPAL INVESTIGATOR

  • Patrik Nyberg

    Universitetssjukhuset i Linkoping

    PRINCIPAL INVESTIGATOR

  • Anna Lange-Jendeberg

    Universitetssjukhuset i Orebro

    PRINCIPAL INVESTIGATOR

  • Ryan Arnold

    The Cooper Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 12, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

April 14, 2017

Record last verified: 2017-04

Locations

US(1)SE(4)