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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04782843
Collaborator
(none)
124
2

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated 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.
Anticipated Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
May 1, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Intraobserver agreeement for the HEP score [3 months]

    Intraobserver agreeement for the HEP score

Secondary Outcome Measures

  1. Interobserver agreement for the HEP score [3 months]

    Interobserver agreement for the HEP score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Guillaume Besch, MD, CHRU J. Minjoz à Besançon

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT04782843
Other Study ID Numbers:
  • 2021/586
First Posted:
Mar 4, 2021
Last Update Posted:
Mar 4, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 4, 2021