Prognosis Related to Induced Thrombopenia With Heparin Under Venoarterial ECMO in Reanimation (TIH ECMO)

Thrombocytopenia is a frequent and serious adverse event in patients treated with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for refractory cardiogenic shock. Similarly to postcardiac surgery patients, heparin-induced thrombocytopenia (HIT) could represent the causative underlying mechanism. However, the epidemiology as well as related mortality regarding HIT and VA-ECMO remains largely unknown. The investigators aimed to define the prevalence and associated 90-day mortality of HIT diagnosed under VA-ECMO.This retrospective study included patients under VA-ECMO from 20 French centers between 2012 and 2016.

Study Overview

• Status: Completed
• Conditions: Heparin-induced Thrombocytopenia
• Intervention / Treatment: Other: Hospitalization for more than 3 days with high clinical suspicion of HIT and positive anti-PF4/heparin antibodies

• Study Type: Observational
• Enrollment (Actual): 39

Participation Criteria

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 hospitalized in intensive care for cardiogenic shock requiring cardiac assisting with ECMO-VA.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Patient hospitalized in intensive care for a cardiovascular failure requiring the setting up of an ECMO-VA
• ECMO-VA duration ≥ 3 days
• HIT confirmed by immunological tests
• Patient affiliated to a Social Security scheme

Exclusion Criteria:

• Known antecedent of TIH prior to cannulation
• Pregnant woman
• ECMO-VA following cardiopulmonary arrest or septic shock

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death	90 days after inclusion

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): April 30, 2018
• Study Completion (ACTUAL): April 30, 2018

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (ACTUAL): June 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Immunologic Factors; Anticoagulants; Antibodies; Heparin
• Other Study ID Numbers: PSS 2016/TIH ECMO-KIMMOUN/SR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No