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

NCT02790567 | Completed

• 1 other identifier: TIH-2012
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heparin-induced Thrombocytopenia (HIT)

Keywords

diagnostic performance; heparin-induced thrombocytopenia; rapid immunological diagnostic method; immunoassay; pretest scoring systems; 4Ts score; HEP score

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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.

Other: HEP score; Other: 4Ts score; Other: ID-PaGIA test; Other: HIT-Ab(PF4-H) test

Interventions

HEP score OTHER

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.

Also known as: The HEP score is the HIT Expert Probability score.

HIT study group

4Ts score OTHER

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.

HIT study group

ID-PaGIA test OTHER

The ID-PaGIA test is a particle gel immunoassay that detects immunoglobulins (Ig) G, A and M specific to the heparin/PF4 complexes.

HIT study group

HIT-Ab(PF4-H) test OTHER

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.

Also known as: HIT-Ab(PF4-H) latex agglutination test

HIT study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \> 18 years old
• Diagnosis of HIT suspected
• Admitted in our surgical intensive care unit during the study period

You may not qualify if:

• Age \< 18 years old
• Pregnancy and/or breast feeding
• Fondaparinux anticoagulation
• Withdrawal of consent

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25030, France

Location

MeSH Terms

Interventions

Latex Fixation Tests

Intervention Hierarchy (Ancestors)

Agglutination Tests; Serologic Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Marc Ginet, MD

  Centre Hospitalier Universitaire de Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: June 6, 2016
• Study Start: October 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 30, 2016

Record last verified: 2013-05

Locations

FR (1)