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

COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367896
• Other study ID #: Covid-19_V1
• Status: Completed
• Start date: March 24, 2020
• Est. completion date: April 17, 2020

Study information

• Verified date: April 2020
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1819
• Est. completion date: April 17, 2020
• Est. primary completion date: April 17, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario "Agostino Gemelli"	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Leon DA, Shkolnikov VM, Smeeth L, Magnus P, Pechholdová M, Jarvis CI. COVID-19: a need for real-time monitoring of weekly excess deaths. Lancet. 2020 Apr 22. pii: S0140-6736(20)30933-8. doi: 10.1016/S0140-6736(20)30933-8. [Epub ahead of print] — View Citation

Redelmeier DA, Shafir E. Pitfalls of judgment during the COVID-19 pandemic. Lancet Public Health. 2020 Apr 23. pii: S2468-2667(20)30096-7. doi: 10.1016/S2468-2667(20)30096-7. [Epub ahead of print] — View Citation

Ritschl PV, Nevermann N, Wiering L, Wu HH, Morodor P, Brandl A, Hillebrandt K, Tacke F, Friedersdorff F, Schlomm T, Schöning W, Öllinger R, Schmelzle M, Pratschke J. Solid Organ Transplantation Programs Facing Lack of Empiric Evidence in the COVID-19 Pand — View Citation

The Lancet. India under COVID-19 lockdown. Lancet. 2020 Apr 25;395(10233):1315. doi: 10.1016/S0140-6736(20)30938-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Management of Solid Organ Transplant during COVID-19 pandemic	Question 1"Given the COVID-19 outbreak, should liver transplant activities be stopped?" with three possible answers (Completely, Selectively and Not at All)	20/04/2020
Primary	Equity of resource distribution	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).	20/04/2020
Secondary	Equity rank of resource distribution	Scale (10 strongly agree- 0 strongly disagree).	20/04/2020