Clinical Trials Logo
  1. Home
  2. Heparin-Induced Thrombocytopenia
  3. NCT04782843
  4. Details
NCT04782843 Clinical Trial

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

Heparin-induced Thrombocytopenia Clinical Trial

— REPROHEP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04782843
Other study ID # 2021/586
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date May 1, 2021

Study information
Verified date February 2021
Source Centre Hospitalier Universitaire de Besancon
Contact Rudy Alardin, Intern
Phone 0621605385
Email ralardin@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 124
Est. completion date May 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• HEP score assessement
Assessement of the HEP score between 2 physician.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Intraobserver agreeement for the HEP score Intraobserver agreeement for the HEP score 3 months
Secondary Interobserver agreement for the HEP score Interobserver agreement for the HEP score 3 months
See also
  Status Clinical Trial Phase
Withdrawn NCT00759083 - Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients Phase 4
Completed NCT00412464 - Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis Phase 1
Completed NCT00456326 - Heparin-Induced Thrombocytopenia Registry N/A
Terminated NCT00673439 - Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT) Phase 2
Active, not recruiting NCT00198575 - A Study on the Prevalence of Heparin-Induced Thrombocytopenia in Cardiovascular Patients N/A
Completed NCT00283322 - Heparin Antibodies in Intensive Care Unit Patients (HAICU) N/A
Not yet recruiting NCT05586854 - Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia N/A
Not yet recruiting NCT03269019 - Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia N/A
Not yet recruiting NCT06066762 - Argatroban Monitoring in Acute Suspected Heparin-induced Thrombocytopenia.
Terminated NCT03809481 - Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban Phase 3
Completed NCT05325346 - A Phase I Study of the Co-administration of VLX-1005 and Argatroban in Healthy Human Subjects Phase 1
Recruiting NCT02717039 - Pharmacogenomics of Heparin-Induced Thrombocytopenia
Completed NCT02526485 - Immunogenetics of Heparin-Induced Thrombocytopenia: Aim 2
Completed NCT00748839 - Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical N/A
Recruiting NCT05783895 - Comparison of Pre-test Probability Model for Heparin-induced Thrombocytopenia in Post-operative Cardiac Surgery
Completed NCT00198588 - Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia Phase 3
Recruiting NCT04842760 - PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer
Terminated NCT01598168 - Rivaroxaban for Treatment of Patients With Suspected or Confirmed Heparin-Induced Thrombocytopenia Phase 3
Completed NCT01654848 - Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients N/A
Withdrawn NCT00603824 - Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT) Phase 4

External Links