- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02790567
Rapid Diagnosis of Heparin-Induced Thrombocytopenia in Surgical Critically Ill Patients (TIH)
June 29, 2016 updated by: Centre Hospitalier Universitaire de Besancon
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Besançon, France, 25030
- Centre Hospitalier Universitaire de Besançon
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Age > 18 years old
- Diagnosis of HIT suspected
- Admitted in our surgical intensive care unit during the study period
Exclusion Criteria:
- Age < 18 years old
- Pregnancy and/or breast feeding
- Fondaparinux anticoagulation
- Withdrawal of consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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 Names:
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.
The ID-PaGIA test is a particle gel immunoassay that detects immunoglobulins (Ig) G, A and M specific to the heparin/PF4 complexes.
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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during the ICU stay, i.e an average time of 10 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Sensibility, specificity, positive and negative predictive values of the 4Ts score for the diagnosis of heparin-induced thrombocytopenia (HIT)
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during the ICU stay, i.e an average time of 10 days
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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
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Sensibility, specificity, positive and negative predictive value of the particul gel immunoassay ID-PaGia test for the diagnosis of heparin-induced thrombocytopenia (HIT)
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during the ICU stay, i.e an average time of 10 days
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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
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Sensibility, specificity, positive and negative predictive values of the automated immunoassay HemosIL-Ab latex agglutination test for the diagnosis of heparin-induced thrombocytopenia (HIT)
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during the ICU stay, i.e an average time of 10 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marc Ginet, MD, Centre Hospitalier Universitaire de Besançon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
August 1, 2013
First Submitted That Met QC Criteria
May 31, 2016
First Posted (Estimate)
June 6, 2016
Study Record Updates
Last Update Posted (Estimate)
June 30, 2016
Last Update Submitted That Met QC Criteria
June 29, 2016
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TIH-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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