NCT03979625

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

2.3 years

First QC Date

June 6, 2019

Last Update Submit

June 6, 2019

Conditions

Heparin-induced Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Death

    90 days after inclusion

Interventions

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Hospitalization

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 7, 2019

Study Start

January 1, 2016

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

June 7, 2019

Record last verified: 2019-06