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

NCT ID: NCT04782843

Last Updated: 2021-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heparin-induced Thrombocytopenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

HEP score assessement

Intervention Type OTHER

Assessement of the HEP score between 2 physician.

Interventions

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HEP score assessement

Assessement of the HEP score between 2 physician.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Besch, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU J. Minjoz à Besançon

Central Contacts

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Rudy Alardin, Intern

Role: CONTACT

0621605385

References

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Cuker A, Arepally G, Crowther MA, Rice L, Datko F, Hook K, Propert KJ, Kuter DJ, Ortel TL, Konkle BA, Cines DB. The HIT Expert Probability (HEP) Score: a novel pre-test probability model for heparin-induced thrombocytopenia based on broad expert opinion. J Thromb Haemost. 2010 Dec;8(12):2642-50. doi: 10.1111/j.1538-7836.2010.04059.x.

Reference Type RESULT
PMID: 20854372 (View on PubMed)

Related Links

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Other Identifiers

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2021/586

Identifier Type: -

Identifier Source: org_study_id

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