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COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION (SOT) : AN INTERNATIONAL WEB-BASED SURVEY

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ClinicalTrials.gov Identifier: NCT04367896
Recruitment Status : Completed
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary:

Background COVID-19 has brought into questioning the equitable distribution of resources. Solid Organ Transplants (SOT) are life-saving procedures. Rapid changes in the management of patients are occurring, with potential for inequity. Drawing on professionals across transplant specialities, we investigated resource distribution specifically for SOT to guide healthcare policies.

A multidisciplinary team developed a survey. The survey included demographic questions to contextualise respondents, questions on resource allocation for SOT. Multiple strategies were used to distribute the survey internationally. Descriptive, uni-multivariate ordinal regressions analysis were performed. Open comments were analysed using qualitative methods.


Condition or disease Intervention/treatment
COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION Other: Survey Group

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Study Type : Observational
Actual Enrollment : 1819 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION (SOT) : AN INTERNATIONAL WEB-BASED SURVEY
Actual Study Start Date : March 24, 2020
Actual Primary Completion Date : April 17, 2020
Actual Study Completion Date : April 17, 2020

Intervention Details:
  • Other: Survey Group

    The survey sought to elucidate equity principles that are influencing transplant decision making. The group of respondents included solid organ transplant doctors (surgeons, referring doctors, transplant physicians, transplant coordinators, ICU transplant doctors), COVID-doctors (ICU doctors, Infectious Disease Doctors, Pulmonologists, Internists), and Ethicists with experience of transplant related issues.

    Respondent identification:

    A. The e-mail addresses of corresponding authors from Scopus January 1, 2017 and march 20, 2020:

    All ("surgery") AND subj ("medi") and key ("transplantation"), All ("critical care") AND subj ("medi") and key ("transplantation"), All ("ethics") AND subj ("medi") and key ("transplantation"). B. Emailing through the mailing list of scientific societies. C. The link to the survey published online. D. The link to the survey circulated through personal contacts and via social media sites.



Primary Outcome Measures :
  1. Management of Solid Organ Transplant during COVID-19 pandemic [ Time Frame: 20/04/2020 ]
    Question 1"Given the COVID-19 outbreak, should liver transplant activities be stopped?" with three possible answers (Completely, Selectively and Not at All)

  2. Equity of resource distribution [ Time Frame: 20/04/2020 ]
    Question 2"I feel that the current policy to allocate most resources to COVID-19 meets the equity of access in healthcare for different diseases" with four possible alternative answers (strongly agree, partially agree, partially disagree and strongly disagree).


Secondary Outcome Measures :
  1. Equity rank of resource distribution [ Time Frame: 20/04/2020 ]
    Scale (10 strongly agree- 0 strongly disagree).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
Country macro regions, subspecilaties and organ of interest
Criteria

Inclusion Criteria:

  • transplant surgeons, referring doctors, transplant physicians, transplant coordinators, transplant ICU doctors, COVID-19 ICU, Infectious Disease Doctors, Pulmonologists, Internist, and Ethicists

Exclusion Criteria:

  • not applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04367896


Locations
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Italy
Fondazione Policlinico Universitario "Agostino Gemelli"
Rome, Italy, 00168
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Publications of Results:
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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT04367896    
Other Study ID Numbers: Covid-19_V1
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
COVID-19
Solid Organ Transplantation