Rapid Diagnosis of Heparin-Induced Thrombocytopenia in Surgical Critically Ill Patients

Heparin-induced Thrombocytopenia (HIT) Clinical Trial

— TIH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790567
• Other study ID #: TIH-2012
• Status: Completed
• Phase: N/A
• First received: August 1, 2013
• Last updated: June 29, 2016
• Start date: October 2012
• Est. completion date: May 2015

Study information

• Verified date: May 2013
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical CommitteeFrance: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical 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 the diagnosis of HIT in surgical patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness
• Heparin-induced Thrombocytopenia (HIT)
• Thrombocytopenia

Intervention

Other:
• HEP 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 score
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 test
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) 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensibility, specificity, positive and negative predictive values of HEP score for the diagnosis of heparin-induced thrombocytopenia (HIT)		during the ICU stay, i.e an average time of 10 days	No
Secondary	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)	during the ICU stay, i.e an average time of 10 days	No
Secondary	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)	during the ICU stay, i.e an average time of 10 days	No
Secondary	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)	during the ICU stay, i.e an average time of 10 days	No