Heparin-induced Thrombocytopenia (HIT)TIHNCT02790567
Rapid Diagnosis of Heparin-Induced Thrombocytopenia in Surgical Critically Ill Patients
An observational study of Heparin-induced Thrombocytopenia (HIT), run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The early diagnosis of heparin-induced thrombocytopenia is particularly difficult in surgical critically ill patients. If the use of rapid immunological diagnostic methods and pretest scoring systems has been proposed in the medical intensive care unit (ICU), none of these methods have been specifically evaluated in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-induced Thrombocytopenia (HIT)
- What is being tested?
- HEP score, 4Ts score and ID-PaGIA test
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to May 2015
- 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: Patients admitted in our surgical intensive care unit (ICU) during the study period will be elligible if the diagnosis of HIT is supected by the attending physician. The diagnosis of the HIT will be suspected in the presence of at least one of the following criteria in a patient receiving an heparin therapy: (1) a thrombocytopenia < 100 G/l or a decrease of the blood platelet count > 40%, (2) a thrombocytopenia between the 5th and the 8th of the heparin therapy, (3)an arterial or a venous thrombosis in a patient receiving heparin, (4)the failure of a treatment of a thrombosis with heparin. These criteria are described in the French guidelines.
Who may be able to join
- Age > 18 years old
- Diagnosis of HIT suspected
- Admitted in our surgical intensive care unit during the study period
Who cannot join
- Age < 18 years old
- Pregnancy and/or breast feeding
- Fondaparinux anticoagulation
- Withdrawal of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Automated Immunoassay, Particle Gel Immunoassay and Pretest Scoring Systems (4Ts and HEP Scores) in the Diagnosis of Heparin-induced Thrombocytopenia in Surgical Critically Ill Patients
The early diagnosis of heparin-induced thrombocytopenia is particularly difficult in surgical critically ill patients. If the use of rapid immunological diagnostic methods and pretest scoring systems has been proposed in the medical intensive care unit (ICU), none of these methods have been specifically evaluated in the diagnosis of HIT in surgical patients.
Read the detailed description
Heparin-induced thrombocytopenia (HIT) is of concern in critically ill patients, given the high prevalence of heparin use. The diagnosis of HIT in surgical intensive care unit (ICU) is problematic due to the lack of reliable diagnostic method. No gold standard currently exists and the definitive diagnosis is mainly based on the detection of heparin-dependent platelet-activating antibodies by ELISA method, on the platelet serotonin release assay (SRA) and on the changes of the blood platelet count after the discontinuation of heparin therapy. As a result, no early definitive diagnosis could be done. This could expose patients to thrombotic complications related to the HIT or hemorrhagic complications related to the alternative anticoagulant prescribed. This complications can threaten the prognosis of these patients. Particle gel immunoassay and automated immunoassay has been proposed for the early diagnosis of HIT in medical critically ill and non-critically ill patients. Many authors suggest that the accuracy of these immunological methods for the diagnosis of HIT could be altered in surgical patients, but these tests has never been specifically evaluated in this population. The 4Ts and the HIT Expert Probability (HEP) score systems sound interesting for the diagnosis of HIT. These clinicobiological scores can be easily used by non-expert clinicians, but have also never been evaluated in the surgical ICU.
- Conditions
- Heparin-induced Thrombocytopenia (HIT)
- Being tested
- HEP score, 4Ts score, ID-PaGIA test, HIT-Ab(PF4-H) test
- Keywords
- diagnostic performance, heparin-induced thrombocytopenia, rapid immunological diagnostic method, immunoassay, pretest scoring systems, 4Ts score, HEP score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEP scoreOther
Also called The HEP score is the HIT Expert Probability score.
The HEP score is a clinicobiological score evaluating the probability of the HIT diagnosis.
The HEP score is based on the blood platelet count, the timing of the platelet decrease, the existence of clinical manifestations of HIT (thrombosis, haemorrhage, skin necrosis) and the existence of an other cause of thrombocytopenia.
4Ts scoreOther
The 4Ts score is a clinicobiological score evaluating the probability of the HIT diagnosis. The 4Ts score is based on the change in blood platelet count during heparin therapy, the timing of platelet decrease, the existence of a thrombosis, and the existence of an other cause of thrombocytopenia.
ID-PaGIA testOther
The ID-PaGIA test is a particle gel immunoassay that detects immunoglobulins (Ig) G, A and M specific to the heparin/PF4 complexes.
HIT-Ab(PF4-H) testOther
Also called HIT-Ab(PF4-H) latex agglutination test
The HIT-Ab(PF4-H) test consist in the incubation of plasma samples with latex beads coated PF4/polyvinylsulfate complexes. After binding of the plasma antibodies a monoclonal antibody recognizing PF4/heparin complexes is added. In the presence of human anti-PF4/heparin antibodies, binding of the monoclonal antibody and subsequent agglutination of latex beads is inhibited. Inhibition of agglutination is quantified and reported in arbitrary units (U/ml). A value equal or higher than 1.0 u/ml may indicate the presence of HIT antibodies.
| Study group | Role | What they receive |
|---|---|---|
| HIT study group | The HIT study group will include all patients admitted in our surgical intensive care unit (ICU) during the study period if the clinician in charge of the patient suspects the diagnosis of HIT. The HEP score, the 4Ts score, the immuno-diffusion particle gel immunoassay (ID-PaGIA) and the HIT-Ab(PF4-H) test will be done for each patient the day the diagnosis of HIT will be suspected. Receives: Other: HEP score; Other: 4Ts score; Other: ID-PaGIA test; Other: HIT-Ab(PF4-H) test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility, specificity, positive and negative predictive values of HEP score for the diagnosis of heparin-induced thrombocytopenia (HIT)
Measured: during the ICU stay, i.e an average time of 10 days
Secondary outcomes (3)
Sensibility, specificity, positive and negative predictive values of the 4Ts score for the diagnosis of heparin-induced thrombocytopenia (HIT)
Sensibility, specificity, positive and negative predictive values of the 4Ts score for the diagnosis of heparin-induced thrombocytopenia (HIT)
Measured: during the ICU stay, i.e an average time of 10 days
Sensibility, specificity, positive and negative predictive value of the particul gel immunoassay ID-PaGia test for the diagnosis of heparin-induced thrombocytopenia (HIT)
Sensibility, specificity, positive and negative predictive value of the particul gel immunoassay ID-PaGia test for the diagnosis of heparin-induced thrombocytopenia (HIT)
Measured: during the ICU stay, i.e an average time of 10 days
Sensibility, specificity, positive and negative predictive values of the automated immunoassay HemosIL-Ab latex agglutination test for the diagnosis of heparin-induced thrombocytopenia (HIT)
Sensibility, specificity, positive and negative predictive values of the automated immunoassay HemosIL-Ab latex agglutination test for the diagnosis of heparin-induced thrombocytopenia (HIT)
Measured: during the ICU stay, i.e an average time of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startOct 2012
- Primary completionMay 2015
- Study completionMay 2015
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 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
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Ginet, MD, Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790567
- Sponsor's protocol ID
- TIH-2012
- Acronym
- TIH
- Status last verified
- May 2013
- First submitted
- 1 Aug 2013
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Automated Immunoassay, Particle Gel Immunoassay and Pretest Scoring Systems (4Ts and HEP Scores) in the Diagnosis of Heparin-induced Thrombocytopenia in Surgical Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02790567
- Acronym / sponsor ID
- TIH / TIH-2012
- Conditions
- Heparin-induced Thrombocytopenia (HIT)
- Keywords
- diagnostic performance, heparin-induced thrombocytopenia, rapid immunological diagnostic method, immunoassay, pretest scoring systems, 4Ts score, HEP score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Jun 2016 (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.
The early diagnosis of heparin-induced thrombocytopenia is particularly difficult in surgical critically ill patients. If the use of rapid immunological diagnostic methods and pretest scoring systems has been proposed in the medical intensive care unit (ICU), none of these methods have been specifically evaluated in the diagnosis of HIT in surgical patients.
Detailed description
Heparin-induced thrombocytopenia (HIT) is of concern in critically ill patients, given the high prevalence of heparin use. The diagnosis of HIT in surgical intensive care unit (ICU) is problematic due to the lack of reliable diagnostic method. No gold standard currently exists and the definitive diagnosis is mainly based on the detection of heparin-dependent platelet-activating antibodies by ELISA method, on the platelet serotonin release assay (SRA) and on the changes of the blood platelet count after the discontinuation of heparin therapy. As a result, no early definitive diagnosis could be done. This could expose patients to thrombotic complications related to the HIT or hemorrhagic complications related to the alternative anticoagulant prescribed. This complications can threaten the prognosis of these patients. Particle gel immunoassay and automated immunoassay has been proposed for the early diagnosis of HIT in medical critically ill and non-critically ill patients. Many authors suggest that the accuracy of these immunological methods for the diagnosis of HIT could be altered in surgical patients, but these tests has never been specifically evaluated in this population. The 4Ts and the HIT Expert Probability (HEP) score systems sound interesting for the diagnosis of HIT. These clinicobiological scores can be easily used by non-expert clinicians, but have also never been evaluated in the surgical ICU.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIT study group | – | Other: HEP score, Other: 4Ts score, Other: ID-PaGIA test, Other: HIT-Ab(PF4-H) testThe HIT study group will include all patients admitted in our surgical intensive care unit (ICU) during the study period if the clinician in charge of the patient suspects the diagnosis of HIT. The HEP score, the 4Ts score, the immuno-diffusion particle gel immunoassay (ID-PaGIA) and the HIT-Ab(PF4-H) test will be done for each patient the day the diagnosis of HIT will be suspected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in our surgical intensive care unit (ICU) during the study period will be elligible if the diagnosis of HIT is supected by the attending physician. The diagnosis of the HIT will be suspected in the presence of at least one of the following criteria in a patient receiving an heparin therapy: (1) a thrombocytopenia < 100 G/l or a decrease of the blood platelet count > 40%, (2) a thrombocytopenia between the 5th and the 8th of the heparin therapy, (3)an arterial or a venous thrombosis in a patient receiving heparin, (4)the failure of a treatment of a thrombosis with heparin. These criteria are described in the French guidelines.
Key inclusion criteria (3 listed)
- Age > 18 years old
- Diagnosis of HIT suspected
- Admitted in our surgical intensive care unit during the study period
Key exclusion criteria (4 listed)
- Age < 18 years old
- Pregnancy and/or breast feeding
- Fondaparinux anticoagulation
- Withdrawal of consent
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 scoreAlso: The HEP score is the HIT Expert Probability score.The HEP score is a clinicobiological score evaluating the probability of the HIT diagnosis. The HEP score is based on the blood platelet count, the timing of the platelet decrease, the existence of clinical manifestations of HIT (thrombosis, haemorrhage, skin necrosis) and the existence of an other cause of thrombocytopenia. | Other | HIT study group |
| 4Ts scoreThe 4Ts score is a clinicobiological score evaluating the probability of the HIT diagnosis. The 4Ts score is based on the change in blood platelet count during heparin therapy, the timing of platelet decrease, the existence of a thrombosis, and the existence of an other cause of thrombocytopenia. | Other | HIT study group |
| ID-PaGIA testThe ID-PaGIA test is a particle gel immunoassay that detects immunoglobulins (Ig) G, A and M specific to the heparin/PF4 complexes. | Other | HIT study group |
| HIT-Ab(PF4-H) testAlso: HIT-Ab(PF4-H) latex agglutination testThe HIT-Ab(PF4-H) test consist in the incubation of plasma samples with latex beads coated PF4/polyvinylsulfate complexes. After binding of the plasma antibodies a monoclonal antibody recognizing PF4/heparin complexes is added. In the presence of human anti-PF4/heparin antibodies, binding of the monoclonal antibody and subsequent agglutination of latex beads is inhibited. Inhibition of agglutination is quantified and reported in arbitrary units (U/ml). A value equal or higher than 1.0 u/ml may indicate the presence of HIT antibodies. | Other | HIT study group |
Primary outcome
Sensibility, specificity, positive and negative predictive values of HEP score for the diagnosis of heparin-induced thrombocytopenia (HIT)
Time frame: during the ICU stay, i.e an average time of 10 days
3 secondary outcomes
Sensibility, specificity, positive and negative predictive values of the 4Ts score for the diagnosis of heparin-induced thrombocytopenia (HIT)
Time frame: during the ICU stay, i.e an average time of 10 days
Sensibility, specificity, positive and negative predictive value of the particul gel immunoassay ID-PaGia test for the diagnosis of heparin-induced thrombocytopenia (HIT)
Time frame: during the ICU stay, i.e an average time of 10 days
Sensibility, specificity, positive and negative predictive values of the automated immunoassay HemosIL-Ab latex agglutination test for the diagnosis of heparin-induced thrombocytopenia (HIT)
Time frame: during the ICU stay, i.e an average time of 10 days
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 30 Jun 2016.
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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.
Marc Ginet, MD principal investigator
Centre Hospitalier Universitaire de Besancon
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 Centre Hospitalier Universitaire de Besancon 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 3 inclusion and 4 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 30 Jun 2016. 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?
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?
Sensibility, specificity, positive and negative predictive values of HEP score for the diagnosis of heparin-induced thrombocytopenia (HIT) (time frame: during the ICU stay, i.e an average time of 10 days). 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 30 Jun 2016.