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NCT03979625 Clinical Trial

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

Heparin-induced Thrombocytopenia Clinical Trial

— TIH ECMO  

Official title:
Prognosis Related to Induced Thrombopenia With Heparin Under Venoarterial ECMO in Reanimation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03979625
Other study ID # PSS 2016/TIH ECMO-KIMMOUN/SR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date April 30, 2018

Study information
Verified date June 2019
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date April 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Hospitalization for more than 3 days with high clinical suspicion of HIT and positive anti-PF4/heparin antibodies
Patients are classified according to results of functional tests as having either Confirmed or Excluded HIT.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome
Type Measure Description Time frame Safety issue
Primary Death 90 days after inclusion
See also
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