Heparin Binding Protein in Early Sepsis Diagnosis (PROMPT)
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ClinicalTrials.gov Identifier: NCT03295825 |
Recruitment Status :
Completed
First Posted : September 28, 2017
Last Update Posted : October 23, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sepsis Infection | Diagnostic Test: Biomarker | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 400 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Prospective Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein Assay to Indicate the Presence and Outcome of Sepsis in Patients With Suspected Infection Following Emergency Department Admission |
Actual Study Start Date : | September 22, 2017 |
Actual Primary Completion Date : | June 30, 2018 |
Actual Study Completion Date : | September 30, 2018 |

Arm | Intervention/treatment |
---|---|
Biomarker
Blood sampling
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Diagnostic Test: Biomarker
Measument of heparin-binding protein in the serum of patients
Other Name: Heparin Binding Protein |
- ΗΒΡ for sepsis diagnosis [ Time Frame: 72 hours ]Sensitivity of ΗΒΡ for sepsis diagnosis. Every value over 90% is considered satisfactory.
- Diagnostic performance of HBP for sepsis [ Time Frame: 72 hours ]Specificity, positive predictive value and negative predictive value of HBP to diagnose sepsis
- Diagnostic performance of HBP for septic shock [ Time Frame: 72 hours ]Specificity, positive predictive value and negative predictive value of HBP to diagnose septic shock
- Diagnostic performance of HBP for early death [ Time Frame: 72 hours ]Sensitivity, specificity, positive predictive value and negative predictive value of HBP to predict unfavorable outcome
- Diagnostic performance of HBP for death [ Time Frame: 28 days ]Sensitivity, specificity, positive predictive value and negative predictive value of HBP to predict unfavorable outcome

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥18 years
- Male or female
- Written informed consent
- Suspected infection
- Presence of at least ONE of the following:
Temperature > 38°C Temperature < 36°C Heart rate > 90 bpm Respiratory rate > 20/min Self reported fever/chills
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295825
Greece | |
Nafplion General Hospital | |
Náfplio, Argos, Greece, 21100 | |
4th Department of Internal Medicine, ATTIKON University Hospital | |
Athens, Attiki, Greece, 12462 | |
Department of Internal Medicine, Chalkida General Hospital | |
Chalkida, Greece, 34100 | |
Department of Internal Medicine, Siros General Hospital | |
Ermoupolis, Greece, 84100 | |
Department of Internal Medicine, Sparti General Hospital | |
Sparti, Greece, 23100 | |
2nd Department of Surgery, G.Gennimatas Thessaloniki General Hospital | |
Thessaloníki, Greece, 54635 |
Study Chair: | Evangelos Giamarellos-Bourboulis, MD, PhD | National and Kapodistrian University of Athens |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hellenic Institute for the Study of Sepsis |
ClinicalTrials.gov Identifier: | NCT03295825 |
Other Study ID Numbers: |
PROMPT |
First Posted: | September 28, 2017 Key Record Dates |
Last Update Posted: | October 23, 2018 |
Last Verified: | October 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Heparin binding protein Mortality |
Infections Sepsis Toxemia Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
Heparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |