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Evaluation of the Intra-observer Agreement of the HEP Score in Surgical Intensive Care. (REPROHEP)

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ClinicalTrials.gov Identifier: NCT04782843
Recruitment Status : Not yet recruiting
First Posted : March 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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Brief Summary:
The main objective of this work is to assess the intraoperator reproducibility in the calculation of the HEP score in a population of intensive care patients.

Condition or disease Intervention/treatment
Heparin-induced Thrombocytopenia Other: HEP score assessement

Detailed Description:

The "HEP score" (HIT Expert Probability) is also a clinical probability score, created thanks to the experience of clinicians (16). It is very recent and therefore still little studied and little used. In particular, it has not been the subject of a prospective validation study for ICU patients.

The use of this score is therefore not recommended in everyday practice.

However, the literature shows a higher diagnostic value of the HEP score especially for resuscitation-type patients, as well as when used by an operator with little experience. This could be due to greater detail given in consideration of other causes of thrombocytopenia (17).

The main objective of this work is to assess the intraoperator reproducibility in the calculation of the HEP score in a population of intensive care patients.

The secondary objectives will aim to:

  • Evaluate inter-operator reproducibility
  • Determine if the reproducibility of the HEP score is influenced by:

The patient's sex The type of heparin used (LMWH vs UFH) The severity of the patient (IGS2 score) A history of cardiac or orthopedic surgery

The expected consistent benefits allow validation of the HEP score in surgical intensive care (cf. EVHEP-TIH study).

This would allow a better assessment of the pre-test probabilities of TIH with the performance of biological tests.

Study Design
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Study Type : Observational
Estimated Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the Intra-observer Agreement of the HEP Score in Surgical Intensive Care.
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Groups and Cohorts
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Group/Cohort Intervention/treatment
Cohort

he retrospective cohort studied includes all the patients included in a previous study carried out in our center, the objective of which was to study the diagnostic performance of the HEP score in surgical intensive care.

The cohort studied is made up of all patients admitted for surgical resuscitation between October 2011 and October 2013 and validating the following criteria:

  • Inclusion criteria: any adult patient (age ≥ 18 years), admitted to surgical intensive care, treated with heparin (UFH or LMWH), and suspected of TIH by a clinician in the department according to the criteria of the SFAR 2002.
  • Non-inclusion criteria: minor patients, pregnant women and adults incapable.
 Other: HEP score assessement
Assessement of the HEP score between 2 physician.


Outcome Measures
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Primary Outcome Measures :
  1. Intraobserver agreeement for the HEP score [ Time Frame: 3 months ]
    Intraobserver agreeement for the HEP score


Secondary Outcome Measures :
  1. Interobserver agreement for the HEP score [ Time Frame: 3 months ]
    Interobserver agreement for the HEP score


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The cohort studied is made up of all patients admitted for surgical resuscitation between October 2011 and October 2013
Criteria

Inclusion Criteria:

  • any adult patient (age ≥ 18 years), admitted to surgical intensive care, treated with heparin (UFH or LMWH), and suspected of TIH by a clinician in the department according to the criteria of the SFAR 2002.

Exclusion Criteria:

  • Non-inclusion criteria: minor patients, pregnant women and adults incapable
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04782843


Contacts
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Contact: Rudy Alardin, Intern 0621605385 ralardin@chu-besancon.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Guillaume Besch, MD CHRU J. Minjoz à Besançon
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT04782843    
Other Study ID Numbers: 2021/586
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Heparin-induced Thrombocytopenia
HEP score
Additional relevant MeSH terms:
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Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases