Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04782843
Status:
UNKNOWN
Last Update Posted:
2021-03-04
First Post:
2021-03-02
Brief Title:
Evaluation of the Intra-observer Agreement of the HEP Score in Surgical Intensive Care
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
Evaluation of the Intra-observer Agreement of the HEP Score in Surgical Intensive Care
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPROHEP
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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None