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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heparin-induced Thrombocytopenia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 124

Contacts and Locations

• Study Contact: Name: Rudy Alardin, Intern; Phone Number: 0621605385; Email: ralardin@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraobserver agreeement for the HEP score	Intraobserver agreeement for the HEP score	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interobserver agreement for the HEP score	Interobserver agreement for the HEP score	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Guillaume Besch, MD, CHRU J. Minjoz à Besançon

Publications and helpful links

General Publications

• 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.

Helpful Links

• Princeps article

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Heparin-induced Thrombocytopenia; HEP score
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: 2021/586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No