NCT06224088

Brief Summary

In the past three years, in the general intensive care unit in Meir medical center, 25 patients were treated with ECMO, of which two patients were treated with VA ECMO and the rest with VV ECMO. 70% of the patients survived to hospital discharge. ECMO is indicated as a rescue therapy for patients in critical condition suffering from severe cardiac and/or respiratory failure that does not respond to conservative treatment. It can be used as a bridge to recovery or to heart/lung transplantation. ECMO was introduced in the late seventies of the pervious century. Between the years 2006-2011, partly due to the outbreak of the flu epidemic (H1N1), a 433% increase was observed in the use of ECMO worldwide in adults. In light of the outbreak of the Covid-19 epidemic in recent years, another significant increase has been observed. There are short-term and long-term complications of ECMO. Short-term complications include bleeding, thrombosis, hemolysis, HIT, renal and neurological injuries, associated infections, and technical-mechanical problems. Long-term complications include significant physical and psychological consequences that may adversely affect the patient's daily function, especially executive function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 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

First Submitted

Initial submission to the registry

January 15, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

January 15, 2024

Last Update Submit

May 7, 2025

Conditions

Neurocognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Neurocognitive function in ECMO survivors as measured by SF-36 questionnaire

    Neurocognitive function in ECMO survivors one year after hospital discharge as measured by SF-36 questionnaire

    one year after hospital discharge

Interventions

VV ECMOOTHER

treatment with VV ECMO in the ICU

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients treated with VV ECMO who survived to hospital discharge between 2021-2023

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 15, 2024

First Posted

January 25, 2024

Study Start

March 1, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

May 11, 2025

Record last verified: 2025-05

Locations

IL(1)