Heparin-induced ThrombocytopeniaREPROHEPNCT04782843
Evaluation of the Intra-observer Agreement of the HEP Score in Surgical Intensive Care.
An observational study of Heparin-induced Thrombocytopenia, run by Centre Hospitalier Universitaire de Besancon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-induced Thrombocytopenia
- What is being tested?
- HEP score assessement
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort studied is made up of all patients admitted for surgical resuscitation between October 2011 and October 2013
Who may be able to join
- 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.
Who cannot join
- Non-inclusion criteria: minor patients, pregnant women and adults incapable
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Heparin-induced Thrombocytopenia
- Being tested
- HEP score assessement
- Keywords
- Heparin-induced Thrombocytopenia, HEP score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEP score assessementOther
Assessement of the HEP score between 2 physician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: HEP score assessement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraobserver agreeement for the HEP score
Intraobserver agreeement for the HEP score
Measured: 3 months
Secondary outcomes (1)
Interobserver agreement for the HEP score
Interobserver agreement for the HEP score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heparin-induced ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Besch, MD, Principal investigator, CHRU J. Minjoz à Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782843
- Sponsor's protocol ID
- 2021/586
- Acronym
- REPROHEP
- Status last verified
- Feb 2021
- First submitted
- 2 Mar 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20854372
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Intra-observer Agreement of the HEP Score in Surgical Intensive Care.
- ClinicalTrials.gov ID
- NCT04782843
- Acronym / sponsor ID
- REPROHEP / 2021/586
- Conditions
- Heparin-induced Thrombocytopenia
- Keywords
- Heparin-induced Thrombocytopenia, HEP score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: HEP score assessementhe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort studied is made up of all patients admitted for surgical resuscitation between October 2011 and October 2013
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Non-inclusion criteria: minor patients, pregnant women and adults incapable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEP score assessementAssessement of the HEP score between 2 physician. | Other | Cohort |
Primary outcome
Intraobserver agreeement for the HEP score
Time frame: 3 months
Intraobserver agreeement for the HEP score
1 secondary outcome
Interobserver agreement for the HEP score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- Results publication: PubMed 20854372Cuker 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.
- Princeps articleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Besch, MD principal investigator
CHRU J. Minjoz à Besançon
Questions about this trial
What is this clinical trial studying?
An observational study of Heparin-induced Thrombocytopenia, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rudy Alardin, Intern (0621605385, ralardin@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraobserver agreeement for the HEP score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04782843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.