Heparin-induced Thrombocytopenia (HIT)HITNCT06180785
Performance Evaluation of the Biological Diagnosis of HIT
An observational study of Heparin-induced Thrombocytopenia (HIT), run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Heparin-induced thrombocytopenia (HIT) is a severe complication of heparin therapy with a non-negligible incidence (estimated at 2.6% of unfractionated heparin treatments and 0.2% of low molecular weight heparin treatments). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-induced Thrombocytopenia (HIT)
- How many people
- 894 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2022to Dec 2023
- 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: Adult patient (≥ 18 years of age) hospitalized at HUS between 01/01/2009 and 31/12/2019
Who may be able to join
- Adult patient (≥ 18 years of age)
- Hospitalized at HUS between 01/01/2009 and 31/12/2019
- Specimen sent to the HUS Hematology Laboratory for biological diagnosis of HIT between 01/01/2009 and 31/12/2019
- Data collected by the CRPV and analyzed by the HIT multidisciplinary group in order to reach a consensus decision on the presence or absence of HIT
- Patient does not object to the reuse of his medical data for scientific research purposes.
Who cannot join
- Patient for whom no test has been performed at the HUS Hematology Laboratory
- Patient for whom no data has been collected by the CRPV
- Patient for whom the HIT group could not confirm or deny the presence of HIT
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Laboratoire d'Hématologie - CHU de Strasbourg - France
Strasbourg, 67091
Agathe HERB, PharmD, 33 3 88 12 75 53, agathe.herb@chru-strasbourg.fr
Agathe HERB, PharmD
About this study
Official title: Performance Evaluation of the Biological Diagnosis of Heparin-induced Thrombocytopenia (HIT)
Heparin-induced thrombocytopenia (HIT) is a severe complication of heparin therapy with a non-negligible incidence (estimated at 2.6% of unfractionated heparin treatments and 0.2% of low molecular weight heparin treatments). It is generally secondary to the appearance of IgG antibodies directed against the platelet factor 4 (PF4) - heparin complex. These antibodies, once bound to this complex, are likely to activate platelets: the thrombotic risk generated can be potentially fatal.
- Conditions
- Heparin-induced Thrombocytopenia (HIT)
- Keywords
- Heparin-induced thrombocytopenia, HIT, heparin therapy, heparin treatments, molecular weight heparin, IgG antibodies, platelet factor 4 (PF4), heparin complex, thrombotic risk
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of the biological diagnosis approach for heparin-induced thrombocytopenia (HIT) in the Hematology laboratory of the University Hospitals of Strasbourg
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start27 Jun 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heparin-induced Thrombocytopenia (HIT)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 894 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180785
- Sponsor's protocol ID
- 8665
- Acronym
- HIT
- Status last verified
- Dec 2023
- First submitted
- 6 Sep 2022
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the Biological Diagnosis of Heparin-induced Thrombocytopenia (HIT)
- ClinicalTrials.gov ID
- NCT06180785
- Acronym / sponsor ID
- HIT / 8665
- Conditions
- Heparin-induced Thrombocytopenia (HIT)
- Keywords
- Heparin-induced thrombocytopenia, HIT, heparin therapy, heparin treatments, molecular weight heparin, IgG antibodies, platelet factor 4 (PF4), heparin complex
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 894 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Dec 2023 (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.
Heparin-induced thrombocytopenia (HIT) is a severe complication of heparin therapy with a non-negligible incidence (estimated at 2.6% of unfractionated heparin treatments and 0.2% of low molecular weight heparin treatments). It is generally secondary to the appearance of IgG antibodies directed against the platelet factor 4 (PF4) - heparin complex. These antibodies, once bound to this complex, are likely to activate platelets: the thrombotic risk generated can be potentially fatal.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥ 18 years of age) hospitalized at HUS between 01/01/2009 and 31/12/2019
Key inclusion criteria (5 listed)
- Adult patient (≥ 18 years of age)
- Hospitalized at HUS between 01/01/2009 and 31/12/2019
- Specimen sent to the HUS Hematology Laboratory for biological diagnosis of HIT between 01/01/2009 and 31/12/2019
- Data collected by the CRPV and analyzed by the HIT multidisciplinary group in order to reach a consensus decision on the presence or absence of HIT
- Patient does not object to the reuse of his medical data for scientific research purposes.
Key exclusion criteria (3 listed)
- Patient for whom no test has been performed at the HUS Hematology Laboratory
- Patient for whom no data has been collected by the CRPV
- Patient for whom the HIT group could not confirm or deny the presence of HIT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective description of the biological diagnosis approach for heparin-induced thrombocytopenia (HIT) in the Hematology laboratory of the University Hospitals of Strasbourg
Time frame: through study completion, an average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heparin-induced Thrombocytopenia (HIT), run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 3 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 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Agathe HERB, PharmD (33 3 88 12 75 53, agathe.herb@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of the biological diagnosis approach for heparin-induced thrombocytopenia (HIT) in the Hematology laboratory of the University Hospitals of Strasbourg (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2023.