NCT04782843

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

March 4, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

March 2, 2021

Last Update Submit

March 2, 2021

Conditions

Keywords

Heparin-induced ThrombocytopeniaHEP score

Outcome Measures

Primary Outcomes (1)

  • Intraobserver agreeement for the HEP score

    Intraobserver agreeement for the HEP score

    3 months

Secondary Outcomes (1)

  • Interobserver agreement for the HEP score

    3 months

Study Arms (1)

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

Interventions

Assessement of the HEP score between 2 physician.

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The cohort studied is made up of all patients admitted for surgical resuscitation between October 2011 and October 2013

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Related Links

Study Officials

  • Guillaume Besch, MD

    CHRU J. Minjoz à Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rudy Alardin, Intern

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 4, 2021

Study Start

March 1, 2021

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

March 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share