Heparin-induced ThrombocytopeniaScore-TIHNCT00748839
Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical
An observational study of Heparin-induced Thrombocytopenia, run by Centre Hospitalier Universitaire de Saint Etienne at 27 sites in France.
Trial summary
Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52 % at one month if no specific treatment is initiated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-induced Thrombocytopenia
- How many people
- 2,700 participants
- Where
- 27 sitesFrance
- Study dates
- Mar 2009to Nov 2012
- 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: community sample
Who may be able to join
- all patients presenting, either during or immediately after treatment:
- thrombocytopenia and/or venous or arterial thrombosis
- for whom a request for biological assessment to check for HIT (anti-H-PF4 ELISA test) is to be addressed to the specialized haemostasis laboratory participating in the study
Who cannot join
- do not possess sufficient clinical data prior to performance of the biological test
- cannot assure follow-up of the patient until normalization of the platelet count
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
ETS de Franche Conté - Laboratoire d'Immuno Hématologie
Besançon, 25020
CHU Cavale Blanche Laboratoire d'Hématologie
Brest, 29609
Laboratoire d'hématologie - Hôpital Louis Pradel
Bron, 69500
Hôpital Antoine Beclère - Laboratoire d'hématologie
Clamart, 92141
Laboratoire d'hématologie - CHU de Clermont Ferrand
Clermont-Ferrand, 63003
HCC Colmar - laboratoire d'hématologie
Colmar, 68024
Laboratoire d'Hématologie - CHU le Bocage
Dijon, 21034
Laboratoire d'hémostase - CCML
Le Plessis-Robinson, 92350
Hôpital Cardiologique - Laboratoire d'Hémostase
Lille, 59037
CHU La Timone - Laboratoire Hématologie
Marseille, 13385
Hôpital SAINT ELOI - CHU de Montpellier - Laboratoire d'Hématologie
Montpellier, 34295
Hématologie biologique - CHU Nancy
Nancy, 54511
HOTEL DIEU - CHU Nantes - Laboratoire d'Hématologie
Nantes, 44093
Hématologie Biologique - Hôpital Tenon,
Paris, 75002
Hôpital Necker Enfants Malades -Laboratoire d'Hématologie
Paris, 75015
Hôpital BICHAT - Service d'hématologie immunologie
Paris, 75018
G.H. Pitié Salpétrière - Labo Hémostase Pavillon Laveran
Paris, 75851
Hôpital Européen Georges Pompidou - Service Hématologie Biologique A
Paris, 75908
Hôpital Cardiologique - CHU Bordeaux
Pessac, 33604
Laboratoire central d'hématologie - Hôpital R. DEBRE
Reims, 51092
CHU de ROUEN
Rouen, 76031
Laboratoire d'hématologie
Saint-Etienne, 42055
Service d'Urgence et de Réanimation
Saint-Etienne, 42055
CHU Strasbourg Hautepierre Laboratoire d'Hématologie
Strasbourg, 67098
CMC Foch Laboratoire d'hémostase
Suresnes, 92151
Hopital Purpan - Laboratoire d'hématologie
Toulouse, 31059
CHU Trousseau - CTH - Service d'Hématologie Hémostase
Tours, 37044
About this study
Official title: Heparin-Induced Thrombocytopenia : Development and Validation of a Predictive Clinical Score: a Prospective Multicenter Study Under the Auspices of the French Haemostasis and Thrombosis Study Group (GEHT)in Cooperation With the French Association of Regional PharmacoVigilance Center (AFCRPV)
Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52 % at one month if no specific treatment is initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to permit appropriate management of this rare condition.
During the acute phase of HIT, clinicians and biologists can only suspect this complication with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive or specific to confirm or refute thr diagnosis of HIT.
Read the detailed description
Purpose : To create and validate a score predicting the diagnosis of HIT
- Conditions
- Heparin-induced Thrombocytopenia
- Keywords
- HIT, Heparin-induced thrombocytopenia, heparin treatment, venous thrombosis, arterial thrombosis, predictive clinical score, biological test, anti-H-PF4 antibodies
- Medical subject headings
- Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
the final diagnosis of HIT established by five independent experts in haemostasis and determined by thrombocytopenia and confirmation of HIT by immunological and/or functional tests
Measured: inclusion and 40 days after the inclusion
Secondary outcomes (2)
pathogenic nature of anti HPF4 antibodies of IgM and IgA type
Measured: inclusion
new biological test detecting HIT
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startMar 2009
- Primary completionNov 2012
- Study completionNov 2012
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 Saint EtienneThe 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
- Prospective
- Enrolment
- 2,700 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hyphen BioMed, CIC-EC de Saint-Etienne, Groupe d'étude sur l'Hémostase et la Thrombose, Association Française des centres régionaux de Pharmacovigilance, Laboratoires Organon, Sanofi
- Responsible party
- Sponsor
- Investigators
- Bernard TARDY, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748839
- Sponsor's protocol ID
- 0801016
- Acronym
- Score-TIH
- Status last verified
- Nov 2012
- First submitted
- 5 Sep 2008
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tardy-Poncet B, de Maistre E, Pouplard C, Presles E, Alhenc-Gelas M, Lasne D, Horellou MH, Mouton C, Serre-Sapin A, Bauters A, Nguyen P, Mullier F, Perrin J, Le Gal G, Morange PE, Grunebaum L, Lillo-Le Louet A, Elalamy I, Gruel Y, Greinacher A, Lecompte T, Tardy B; GFHT-HIT study group. Heparin-induced thrombocytopenia: Construction of a pretest diagnostic score derived from the analysis of a prospective multinational database, with internal validation. J Thromb Haemost. 2021 Aug;19(8):1959-1972. doi: 10.1111/jth.15344. Epub 2021 Jun 14.
PubMed 33872452
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin-Induced Thrombocytopenia : Development and Validation of a Predictive Clinical Score: a Prospective Multicenter Study Under the Auspices of the French Haemostasis and Thrombosis Study Group (GEHT)in Cooperation With the French Association of Regional PharmacoVigilance Center (AFCRPV)
- ClinicalTrials.gov ID
- NCT00748839
- Acronym / sponsor ID
- Score-TIH / 0801016
- Conditions
- Heparin-induced Thrombocytopenia
- Keywords
- HIT, Heparin-induced thrombocytopenia, heparin treatment, venous thrombosis, arterial thrombosis, predictive clinical score, biological test, anti-H-PF4 antibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,700 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Hyphen BioMed, CIC-EC de Saint-Etienne, Groupe d'étude sur l'Hémostase et la Thrombose, Association Française des centres régionaux de Pharmacovigilance, Laboratoires Organon, Sanofi
- Study start
- Mar 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Sep 2008 (estimated)
- 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.
Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52 % at one month if no specific treatment is initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to permit appropriate management of this rare condition.
During the acute phase of HIT, clinicians and biologists can only suspect this complication with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive or specific to confirm or refute thr diagnosis of HIT.
Detailed description
Purpose : To create and validate a score predicting the diagnosis of HIT
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (3 listed)
- all patients presenting, either during or immediately after treatment:
Key exclusion criteria (2 listed)
- do not possess sufficient clinical data prior to performance of the biological test
- cannot assure follow-up of the patient until normalization of the platelet count
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
the final diagnosis of HIT established by five independent experts in haemostasis and determined by thrombocytopenia and confirmation of HIT by immunological and/or functional tests
Time frame: inclusion and 40 days after the inclusion
2 secondary outcomes
pathogenic nature of anti HPF4 antibodies of IgM and IgA type
Time frame: inclusion
new biological test detecting HIT
Time frame: inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Derived from this study: PubMed 33872452Tardy-Poncet B, de Maistre E, Pouplard C, Presles E, Alhenc-Gelas M, Lasne D, Horellou MH, Mouton C, Serre-Sapin A, Bauters A, Nguyen P, Mullier F, Perrin J, Le Gal G, Morange PE, Grunebaum L, Lillo-Le Louet A, Elalamy I, Gruel Y, Greinacher A, Lecompte T, Tardy B; GFHT-HIT study group. Heparin-induced thrombocytopenia: Construction of a pretest diagnostic score derived from the analysis of a prospective multinational database, with internal validation. J Thromb Haemost. 2021 Aug;19(8):1959-1972. doi: 10.1111/jth.15344. Epub 2021 Jun 14.
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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.
Bernard TARDY, MD principal investigator
CHU de Saint-Etienne
27 sites 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, run by Centre Hospitalier Universitaire de Saint Etienne at 27 sites 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the final diagnosis of HIT established by five independent experts in haemostasis and determined by thrombocytopenia and confirmation of HIT by immunological and/or functional tests (time frame: inclusion and 40 days after the inclusion). 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 NCT00748839, 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 27 Nov 2012.