Assessing the Impact of COVID-19 Patients Long Distance Transfers Between Intensive Care Units (TRANSCOV)

June 17, 2021 updated by: Olivier Grimaud, Ecole des Hautes Etudes en Santé Publique

TRANSCOV Cohort. An Epidemiological Study Assessing the Impact of Critically Ill COVID-19 Patients Long Distance Transfers Between Intensive Care Units

The TRANSCOV cohort is a multicentre observational retrospective study aiming at assessing the health impact of extra regional transfers of critically ill COVID-19 patients.

Study Overview

Status

Recruiting

Conditions

Detailed Description

In spring 2020 four regions of France faced a surge of severe Coronavirus (COVID) patients which threatened to overflow local intensive care units (ICU) capacities. As an emergency response, between 03/13/2020 and 04/10/2020, an estimated 661 patients were transferred from overcrowded ICUs to other French regions and neighbouring countries. The study aims at assessing the impact of these inter-ICU transfers on the short and medium term physical and psychological outcomes in this population of severe COVID 19 patients.

All transferred patients between ICUs outside the origin region are invited to take part. For each transfer, up to four control patients will be selected among those admitted in the same ICU during the same period (+/-4 days of transfer date). Clinical data will be extracted from medical records and will include hemodynamic and respiratory parameters, as well as clinical severity scores before, during and after transfer. Data linkage with medico-administrative data will enrich the clinical database and allow follow-up up to one year after initial admission.

Study Type

Observational

Enrollment (Anticipated)

3060

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Severely ill COVID-19 patients

Description

Inclusion Criteria:

  • COVID-19 patients diagnosed biologically or by imaging
  • Admission in ICU between 03/13/2020 and 04/10/2020

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transferred group
The transferred group includes all severe COVID patients admitted in a French ICU ward and then transferred between the 03/13/2020 and 04/10/2020 to another ICU located outside the region of the initial ICU stay.
Individual or grouped transportation between ICU of severely ill patients using ambulance, plane, helicopter, train or boat, with specialist medical assistance.
Control group
The control group includes patients selected out of those whose entire ICU care has taken place in one of the hospitals which transferred patients. Up to 4 control patients will be selected for each transferred patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 1 year
Status alive or dead
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Olivier Grimaud, Ph.D., M.D., Ecole des Hautes Etudes en Santé Publique

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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