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OpenTrials
Completed

NCT Number: NCT03979625

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hospitalization for more than 3 days with high clinical suspicion of HIT and positive anti-PF4/heparin antibodies

Other

Patients are classified according to results of functional tests as having either Confirmed or Excluded HIT.

Primary outcomes

  1. Death

    Time frame: 90 days after inclusion

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: TIH ECMO

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2019
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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