NCT05080933

Brief Summary

Objective: Veno-venous ECMO has been used as a rescue therapy for patients with severe ARDS associated to influenza A H1N1 and COVID19 viral pneumonia. Little is known about outcome of these patients who required extracorporeal support. Research question: To compare outcome of patients who required VV ECMO for Covid19 and H1N1 associated ARDS

Trial Health

87
On Track

Trial Health Score

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

Enrollment
308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

August 22, 2009

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

11.5 years

First QC Date

October 15, 2021

Last Update Submit

October 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • All cause mortality on day 60 after ECMO initiation

    60 days

Secondary Outcomes (9)

  • Hospital length of stay

    90 days

  • ICU length of stay

    90 days

  • Hospital mortality on day 90 after ECMO initiation

    90 days

  • ECMO duration

    90 days

  • ECMO associated hemorrhagic complications

    60 days

  • +4 more secondary outcomes

Study Arms (2)

COVID-19

H1N1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who required VV ECMO for COVID-19 and influenza A H1N1 associated ARDS

You may qualify if:

  • COVID-19 or influenza A H1N1 (suspected or confirmed) diagnosis
  • Severe ARDS (according to Berlin Definition)
  • VV ECMO
  • Invasive mechanical ventilation through endotracheal tube or tracheostomy

You may not qualify if:

  • Age\<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, 10126, Italy

Location

Related Publications (1)

  • Fanelli V, Giani M, Grasselli G, Mojoli F, Martucci G, Grazioli L, Alessandri F, Mongodi S, Sales G, Montrucchio G, Pizzi C, Richiardi L, Lorini L, Arcadipane A, Pesenti A, Foti G, Patroniti N, Brazzi L, Ranieri V. Extracorporeal membrane oxygenation for COVID-19 and influenza H1N1 associated acute respiratory distress syndrome: a multicenter retrospective cohort study. Crit Care. 2022 Feb 5;26(1):34. doi: 10.1186/s13054-022-03906-4.

MeSH Terms

Conditions

COVID-19Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 15, 2021

First Posted

October 18, 2021

Study Start

August 22, 2009

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

October 18, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations