Randomised sham-controlled double-blind trial evaluating remote ischaemic preconditioning in solid organ transplantation: a study protocol for the RIPTRANS trial

IntroductionRemote ischaemic preconditioning (RIPC) using a non-invasive pneumatic tourniquet is a potential method for reducing ischaemia-reperfusion injury. RIPC has been extensively studied in animal models and cardiac surgery, but scarcely in solid organ transplantation. RIPC could be an inexpensive and simple method to improve function of transplanted organs. Accordingly, we aim to study whether RIPC performed in brain-dead organ donors improves function and longevity of transplanted organs.Methods and analysesRIPTRANS is a multicentre, sham-controlled, parallel group, randomised superiority trial comparing RIPC intervention versus sham-intervention in brain-dead organ donors scheduled to donate at least one kidney. Recipients of the organs (kidney, liver, pancreas, heart, lungs) from a randomised donor will be included provided that they give written informed consent. The RIPC intervention is performed by inflating a thigh tourniquet to 300 mm Hg 4 times for 5 min. The intervention is done two times: first right after the declaration of brain death and second immediately before transferring the donor to the operating theatre. The sham group receives the tourniquet, but it is not inflated. The primary endpoint is delayed graft function (DGF) in kidney allografts. Secondary endpoints include short-term functional outcomes of transplanted organs, rejections and graft survival in various time points up to 20 years. We aim to show that RIPC reduces the incidence of DGF from 25% to 15%. According to this, the sample size is set to 500 kidney transplant recipients.Ethics and disseminationThis study has been approved by Helsinki University Hospital Ethics Committee and Helsinki University Hospital’s Institutional Review Board. The study protocol was be presented at the European Society of Organ Transplantation congress in Copenhagen 14−15 September 2019. The study results will be submitted to an international peer-reviewed scientific journal for publication.Trial registration numberNCT03855722.

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EFFECTS OF VASOPRESSOR APPLICATION TO BRAIN-DEAD ORGAN DONORS ON GRAFT SURVIVAL IN SOLID ORGAN TRANSPLANTATION.

Transplantation Journal ◽

10.1097/00007890-200004271-00283 ◽

2000 ◽

Vol 69 (Supplement) ◽

pp. S187

Author(s):

Peter Schnuelle ◽

Stefan Berger ◽

Jan de Boer ◽

Giudo Persijn ◽

Fokko J. van der Woude

Keyword(s):

Organ Transplantation ◽

Graft Survival ◽

Solid Organ Transplantation ◽

Solid Organ ◽

Organ Donors ◽

Brain Dead

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Retrospective screening of solid organ donors in Italy, 2009, reveals unpredicted circulation of West Nile virus

Eurosurveillance ◽

10.2807/ese.15.34.19648-en ◽

2010 ◽

Vol 15 (34) ◽

Cited By ~ 14

Author(s):

M R Capobianchi ◽

V Sambri ◽

C Castilletti ◽

A M Pierro ◽

G Rossini ◽

...

Keyword(s):

Risk Assessment ◽

West Nile Virus ◽

Organ Transplantation ◽

Solid Organ Transplantation ◽

Solid Organ ◽

Organ Donors ◽

West Nile ◽

Retrospective Survey ◽

Italian Regions ◽

Potential Risks

Since the occurrence of West Nile virus (WNV) infection in humans in 2008 in Italy, concerns have been raised about the potential risks associated with solid organ transplantation (SOT). A nationwide retrospective survey showed that 1.2% of SOT donors in 2009 were WNV-seropositive and demonstrated that human WNV infection is distributed throughout several Italian regions. Transmission of WNV or other arboviruses through SOT is a possibility and risk assessment should be carried out before SOT to avoid infection through transplantation.

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Effects of Catecholamine Application to Brain-Dead Donors on Graft Survival in Solid Organ Transplantation. Transplantation 2001: 72: 455.

Transplantation Journal ◽

10.1097/00007890-200108150-00002 ◽

2001 ◽

Vol 72 (3) ◽

pp. 362-363

Author(s):

Schnuelle P ◽

Berger S ◽

de Boer J ◽

Persijn G ◽

van der Woude FJ

Keyword(s):

Organ Transplantation ◽

Graft Survival ◽

Solid Organ Transplantation ◽

Solid Organ ◽

Brain Dead

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Corticosteroids in Solid Organ Transplantation: Update and Review of the Literature

Journal of Pharmacy Practice ◽

10.1177/0897190003259838 ◽

2003 ◽

Vol 16 (6) ◽

pp. 380-387 ◽

Cited By ~ 2

Author(s):

Lonnie Smith

Keyword(s):

Organ Transplantation ◽

Immunosuppressive Agents ◽

Solid Organ Transplantation ◽

Early Years ◽

Solid Organ ◽

The Past ◽

Major Interest ◽

Drug Regimens ◽

Transplanted Organs

Corticosteroids have been a constant in immunosuppressive regimens since the beginning of solid organ transplantation. Although the use of corticosteroids allowed the advancement of transplantation in the early years, this came at the price of numerous adverse events for patients. As the survival of transplanted organs has risen over the past several years, increasing attention has been focused on the management of long-term complications. Many of these long-term complications are directly related to the toxicities of immunosuppressive agents. Due to these toxicities, we have seen a resurgence in immunosuppressive protocols that utilize regimens designed to minimize these long-term complications. This has been accomplished by avoiding, reducing or withdrawing one or more medications from the multi-drug regimens. Corticosteroids, with their plethora of side affects, have been of major interest to the transplant community in terms of minimizing side affects by limiting exposure.

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