Regional ethics of surgeon resuscitation for organ transplantation after lethal injury.

BACKGROUND: Trauma patients may present with nonsurvivable injuries, which could be resuscitated for future organ transplantation. Trauma surgeons face an ethical dilemma of deciding whether, when, and how to resuscitate a patient who will not directly benefit from it. As there are no established guidelines to follow, we aimed to describe resuscitation practices for organ transplantation; we hypothesized that resuscitation practices vary regionally. METHOD: Over a 3-month period, we surveyed trauma surgeons practicing in Levels I and II trauma centers within a single state using an instrument to measure resuscitation attitudes and practices for organ preservation. Descriptive statistics were calculated for practice patterns. RESULTS: The survey response rate was 51% (31/60). Many (81%) had experience with resuscitations where the primary goal was to preserve potential for organ transplantation. Many (90%) said they encountered this dilemma at least monthly. All respondents were willing to intubate; most were willing to start vasopressors (94%) and to transfuse blood (84%) (range, 1 unit to >10 units). Of respondents, 29% would resuscitate for ≥24 hours, and 6% would perform a resuscitative thoracotomy. Respect for patients' dying process and future organ quality were the factors most frequently considered very important or important when deciding to stop or forgo resuscitation, followed closely by concerns about excessive resource use. CONCLUSION: Trauma surgeons' regional resuscitation practices vary widely for this patient population. This variation implies a lack of professional consensus regarding initiation and extent of resuscitations in this setting. These data suggest this is a common clinical challenge, which would benefit from further study to determine national variability, areas of equipoise, and features amenable to practice guidelines.

Trasplante de progenitores hematopoyéticos alogénico haploidéntico en aplasia medular, reporte del primer caso en Cuba / Allogenic hematopoietic stem-cell transplantation in marrow aplasia: the first case report in cuba

Introducción: La aplasia medular adquirida grave es una enfermedad hematológica infrecuente caracterizada por una disminución o ausencia de precursores hematopoyéticos en la médula ósea, lo cual se expresa con distintos grados de citopenias. Varios factores, infecciosos o no, pueden incidir en su origen. Su manejo es complejo y puede incluir tratamiento inmunosupresor y trasplante de progenitores hematopoyéticos alogénico. Objetivo: Demostrar la utilidad de la realización del trasplante de progenitores hematopoyéticos alogénico haploidéntico en pacientes con aplasia medular grave. Caso clínico: Paciente masculino de 21 años de edad, con antecedentes de salud, que en octubre del 2018 debutó con íctero, pancitopenia, lesiones purpúrico hemorrágicas en piel y mucosas, en el curso de una hepatitis aguda seronegativa. La biopsia de médula ósea mostró aplasia medular severa. Se inició tratamiento inmunosupresor con globulina antitimocίtica, ciclosporina A y metilprednisolona. Al cabo de los 6 meses mantenía trombocitopenia severa con necesidades transfusionales y en octubre de 2019 se decide realizar trasplante de progenitores hematopoyéticos alogénico con donante haploidéntico y empleando como tratamiento acondicionante globulina antitimocίtica, fludarabina, ciclofosfamida y bajas dosis de irradiación corporal total. En evaluación clίnica de julio de 2020 (dίa + 280 del trasplante) el paciente estaba asintomático y con parámetros hematológicos normales. Conclusiones: Se demostró que el trasplante de progenitores hematopoyéticos alogénico haploidéntico es un proceder realizable y útil en pacientes con aplasia medular grave, lo cual corrobora el beneficio clínico que puede aportar su ejecución en pacientes con esta enfermedad(AU)

Introduction: Acquired severe marrow aplasia is a rare hematological disease characterized by decrease or absence of hematopoietic precursors in bone marrow, which is expressed with different degrees of cytopenias. Several factors, infectious or not, can influence its origin. Its management is complex and may include immunosuppressive treatment and allogeneic hematopoietic stem-cell transplantation. Objective: To demonstrate the usefulness of performing haploidentical allogeneic hematopoietic stem-cell transplantation in patients with severe medullary aplasia. Clinical case: A 21-year-old male patient, with medical history, who first presented, in October 2018, with icterus, pancytopenia, as well as purpuric hemorrhagic lesions on the skin and mucosa, in the course of acute seronegative hepatitis. The bone marrow biopsy showed severe marrow aplasia. Immunosuppressive treatment was started with antithymocytic globulin, cyclosporine A, and methylprednisolone. After six months, he maintained severe thrombocytopenia under transfusion requirements and, in October 2019, the decision was to perform allogeneic hematopoietic stem-cell transplantation with a haploidentical donor and using antithymocyte globulin, fludarabine, cyclophosphamide, and low doses of total body irradiation as conditioning treatment. In the clinical assessment carried out in July 2020 (day +280 after transplantation), the patient was asymptomatic and with normal hematological parameters. Conclusions: Transplantation of haploidentic allogeneic hematopoietic progenitors was shown to be a feasible and useful procedure in patients with severe marrow aplasia, which corroborates the clinical benefit that its execution can bring in patients with this disease(AU)

Conflicts of interest in the context of end of life care for potential organ donors in Australia.

End-of-life (EOL) care has become an integral part of intensive care medicine and includes the exploration of possibilities for deceased organ and tissue donation. Donation physicians are specialist doctors with expertise in EOL processes encompassing organ and tissue donation, who contribute significantly to improvements in organ and tissue donation services in many countries around the world. Donation physicians are usually also intensive care physicians, and thus they may be faced with the dual obligation of caring for dying patients and their families in the intensive care unit (ICU), whilst at the same time ensuring organ and tissue donation is considered according to best practice. This dual obligation poses specific ethical challenges that need to be carefully understood by clinicians, institutions and health care networks. These obligations are complementary and provide a unique skillset to care for dying patients and their families in the ICU. In this paper we review current controversies around EOL care in the ICU, including the use of palliative analgesia and sedation specifically with regards to withdrawal of cardiorespiratory support, the usefulness of the so-called doctrine of double effect to guide ethical decision-making, and the management of potential or perceived conflicts of interest in the context of dual professional roles.

Thewithdrawal of consent to haematopoietic stem cells (HSC) donation: The complicated balance between donor's rights and patient's protection.

Hematopoietic stem cells donation is an essential prerequisite of allogeneic transplantation. Both family donors and matched unrelated donors should have a conscious involvement in every phase of the overall path, from selection to HSC collection. Donors also should be informed about the right to withdraw at any time as well as the extreme risk for recipient's life coming from the decision of interrupting, if the donation is not carried out once the patient's preparative regimen has commenced. We report our challenging experience about a donor who withdraws her consent to HSC donation after 3 days of mobilization with G-CSF. The possibility of withdrawal protects the donor but it also puts at risk both a chance for a transplant and the patient's life if preparative regimen has started. Can the donor really be free to withdraw the consent to HSC donation at any time even when this endangers the life of a recipient? Is this ethical? However, if the donor decides to withdraw, would we really be ready to manage promptly all the consequences coming from the consent revocation? At the moment there is not a well-defined "plan B" in case of impossibility to proceed with the transplant when conditioning has already started or has even been completed. In our opinion, because of this hard balance and such a high risk, it would be necessary to plan every time an alternative strategy which may be different according to different circumstances.

Assessment of Somatic Support Process for Pregnant Brain Death Patients Occurring in a Transition Country Between Asia and Europe from Medical, Ethical, Legal and Religious Aspects.

In spite of the fact that brain death during pregnancy is not a common occurrence, it is an important ethical problem for all cultures and religions can have a significant influence on the donation decision after brain death. Therefore, this study aimed to present the case of a pregnant patient developing brain death which occurred in our intensive care unit and to compare the medical, ethical and legal problems relating to pregnant cases developing brain death with 24 cases in the literature. A 21-year-old 19-week pregnant case with gestational diabetes was monitored in the anesthesia intensive care unit and developed brain death due to intracranial mass and intraventricular hemorrhage. Though brain death is a situation well understood by organ transplant professionals, brain death developing in pregnant patients still involves many medical, ethical and legal problems.

Análise crítica sobre a evolução das normas éticas para a utilização das técnicas de reprodução assistida no Brasil / Critical analysis on the evolution of ethical norms for the use of assisted reproduction techniques in Brazil

Resumo O Conselho Federal de Medicina (CFM) publicou em 1992 a resolução CFM nº 1.358/1992 com o objetivo de adotar normas éticas para utilização das técnicas de Reprodução Assistida (TRA). Esta resolução foi atualizada em 2010 (CFM nº 1.957/2010), em 2013 (CFM Nº 2.013/13) e teve sua última atualização 2015 (CFM nº 2.121/2015). O objetivo desse artigo é fazer uma análise crítica sobre a evolução das normas éticas propostas pelo CFM para a utilização de TRA no Brasil. Foi realizada uma análise documental do texto das quatro Resoluções publicadas onde estão descritas as normas éticas para utilização das TRA. Foi observado que a resolução evoluiu em relação aos direitos dos homossexuais, adotou medidas mais permissivas em relação a criopreservação, doação de gametas e embriões e cessão de útero e por fim autorizou alguns procedimentos em TRA como a reprodução post mortem, doação e gestação compartilhada. A partir de 2013 a resolução ganhou um caráter liberal estando atualizada com a prática clínica. Para as próximas atualizações seria interessante incluir procedimentos em TRA os quais não foram abordados como a transferência nuclear e citoplasmática. A frequência de atualização (a cada dois anos) deve ser mantida para as normas éticas que norteiam a TRA continuar evoluindo juntamente com o avanço da ciência.

Abstract The Federal Medical Council (FMC) published FMC Resolution No. 1,358/1992 with the aim of adopting ethical standards for the use of Assisted Reproduction Techniques (ART). This resolution was updated in 2010 (CFM No. 1957/2010), in 2013 (CFM No. 2,013/13) and the last update was in 2015 (CFM No. 2.121/2015). The scope of this article is to conduct a critical analysis of the evolution of the ethical norms proposed by FMC for the use of ART in Brazil. A documentary analysis of the text of the four published Resolutions was carried out, in which the ethical standards for the use of ART were described. It was observed that the resolution evolved in relation to the rights of homosexuals, adopted more permissive measures regarding cryopreservation, donation of gametes and embryos and uteruses on loan and lastly authorized some procedures in ART such as postmortem reproduction, donation and shared gestation. From 2013 onwards the resolution gained a liberal character being updated in terms of clinical practice. For the next updates it would be interesting to include procedures in ART not previously addressed such as nuclear and cytoplasmic transfer. The update frequency (every two years) should be kept to the ethical standards enabling the ART to continue evolving together with the advancement of science.

Uterine Transplant: A Risk to Life or a Chance for Life?

Being inherently different from any other lifesaving organ transplant, uterine transplantation does not aim at saving lives but supporting the possibility to generate life. Unlike the kidneys or the liver, the uterus is not specifically a vital organ. Given the non-lifesaving nature of this procedure, questions have been raised about its feasibility. The ethical dilemma revolves around whether it is worth placing two lives at risk related to surgery and immunosuppression, amongst others, to enable a woman with absolute uterine factor infertility to experience the presence of an organ enabling childbirth. In the year 2000, the first uterine transplantation, albeit unsuccessful, was performed in Saudi Arabia from where it has spread to the rest of the world including Sweden, the United States and now recently India. The procedure is, however, still in the preclinical stages and several ethical, legal, social and religious concerns are yet to be addressed before it can be integrated into the clinical setting as standard of care for women with absolute uterine factor infertility.

Born to donate: proposals for "savior sibling" regulation in Latin America / Niños creados para servir de donantes de órganos: propuestas para una regulación en América Latina

Abstract A Savior Sibling is a child who is born to provide an organ, bone marrow or cell transplant, to a sibling that is affected with a fatal disease. There are created with the in vitro fertilization and pre-implantation genetic diagnosis and, in the process, the ethical standards for organ donation of children become less demanding. Therefore, we propose that the authorization of the technique considers, unavoidably, the opinion of an impartial third party that can guarantee the welfare of the child. We develop a critical analysis of the laws that regulate the creation of babies to serve as organ donors. We evaluate under what circumstances the organizations that play a part in the decisions, fulfill the ethical standards to allow the organ donation of children.

Resumen Los llamados Savior Sibling son bebés creados con la técnica de la fertilización in vitro y el diagnóstico preimplantacional genético, con el fin de servir como donantes a un hermano afectado por una enfermedad fatal. Se crean con el diagnóstico genético de fertilización in vitro y preimplantación y, en el proceso, las normas éticas para la donación de órganos a niños son menos exigentes. Por esta razón, proponemos que la autorización para llevar a cabo esta técnica considere, como obligatorio, la opinión de un tercero que sea imparcial y que pueda garantizar el bienestar del niño. Se hizo un análisis crítico de las leyes que regulan la creación de estos bebés que sirven como donantes de órganos. Evaluamos bajo qué circunstancias, las organizaciones que participan en estas decisiones cumplen con los estándares éticos para permitir la donación de órganos a niños.

Reuse of cardiac organs in transplantation: an ethical analysis.

BACKGROUND: This paper examines the ethical aspects of organ transplant surgery in which a donor heart is transplanted from a first recipient, following determination of death by neurologic criteria, to a second recipient. Retransplantation in this sense differs from that in which one recipient undergoes repeat heart transplantation of a newly donated organ, and is thus referred to here as "reuse cardiac organ transplantation." METHODS: Medical, legal, and ethical analysis, with a main focus on ethical analysis. RESULTS: From the medical perspective, it is critical to ensure the quality and safety of reused organs, but we lack sufficient empirical data pertaining to medical risk. From the legal perspective, a comparative examination of laws in the United States and Japan affirms no illegality, but legal scholars disagree on the appropriate analysis of the issues, including whether or not property rights apply to transplanted organs. Ethical arguments supporting the reuse of organs include the analogous nature of donation to gifts, the value of donations as inheritance property, and the public property theory as it pertains to organs. Meanwhile, ethical arguments such as those that address organ recycling and identity issues challenge organ reuse. CONCLUSION: We conclude that organ reuse is not only ethically permissible, but even ethically desirable. Furthermore, we suggest changes to be implemented in the informed consent process prior to organ transplantation. The organ transplant community worldwide should engage in wider and deeper discussions, in hopes that such efforts will lead to the timely preparation of guidelines to implement reuse cardiac organ transplantation as well as reuse transplantation of other organs such as kidney and liver.

Broad Consent for Research on Biospecimens: The Views of Actual Donors at Four U.S. Medical Centers.

Commentators are concerned that broad consent may not provide biospecimen donors with sufficient information regarding possible future research uses of their tissue. We surveyed with interviews 302 cancer patients who had recently provided broad consent at four diverse academic medical centers. The majority of donors believed that the consent form provided them with sufficient information regarding future possible uses of their biospecimens. Donors expressed very positive views regarding tissue donation in general and endorsed the use of their biospecimens in future research across a wide range of contexts. Concerns regarding future uses were limited to for-profit research and research by investigators in other countries. These results support the use of broad consent to store and use biological samples in future research.

Ethical Challenges in Hematopoietic Cell Transplantation for Sickle Cell Disease.

Hematopoietic cell transplantation (HCT) using an HLA-identical sibling donor offers a very high likelihood of cure with good outcomes for patients with sickle cell disease (SCD), and alternative donor HCT for SCD is an area of active clinical research. Thus, HCT is a potential option for a growing number of patients with SCD. This expanded use of HCT has raised several ethical questions. Who is eligible for HCT, in terms of both disease severity and psychosocial factors? Should affected children with matched sibling donors undergo HCT only when they have declared themselves as having significant symptomatology? Regarding donors, special ethical challenges include the use of preimplantation genetic diagnosis to conceive an HLA-identical sibling. In this review, we critically analyze various ethical challenges related to HCT for SCD, and offer recommendations to guide clinical care.

[What if the sperm donor has a hereditary disease? Informed consent needed for sharing medical information]. / Wat als de zaaddonor een erfelijke ziekte heeft?

There are no regulations in the Netherlands regarding the exchange of important genetic information that has become available after the birth of a child conceived with donor gametes. This may lead to difficult situations such as when the gamete donor is found to suffer from a genetic cancer-predisposition disorder. Genetic information about the donor that becomes available later may be of great importance to donor offspring. Genetic information uncovered in the donor child may likewise be of importance to legal offspring of the gamete donor. We propose an informed-consent procedure for both donors and recipients to take better care of this issue.

Which Donor for Uterus Transplants: Brain-Dead Donor or Living Donor? A Systematic Review.

BACKGROUND: The aim of this systematic review was to evaluate and compare the pros and cons of using living donors or brain-dead donors in uterus transplantation programs, 2 years after the first worldwide live birth after uterus transplantation. METHODS: The Medline database and the Central Cochrane Library were used to locate uterine transplantation studies carried out in human or nonhuman primates. All types of articles (case reports, original studies, meta-analyses, reviews) in English or French were considered for inclusion. RESULTS: Overall, 92 articles were screened and 44 were retained for review. Proof of concept for human uterine transplantation was demonstrated in 2014 with a living donor. Compared with a brain-dead donor strategy, a living donor strategy offers greater possibilities for planning surgery and also decreases cold ischemia time, potentially translating into a higher success rate. However, this approach poses ethical problems, given that the donor is exposed to surgery risks but does not derive any direct benefit. A brain-dead donor strategy is more acceptable from an ethical viewpoint, but its feasibility is currently unproven, potentially owing to a lack of compatible donors, and is associated with a longer cold ischemia time and a potentially higher rejection rate. CONCLUSIONS: The systematic review demonstrates that uterine transplantation is a major surgical innovation for the treatment of absolute uterine factor infertility. Living and brain-dead donor strategies are not mutually exclusive and, in view of the current scarcity of uterine grafts and the anticipated future rise in demand, both will probably be necessary.

[General and ethical considerations for the informed consent process: Guidelines from the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC)]. / Considérations générales et éthiques pour le recueil d'un consentement éclairé : recommandations de la Société francophone de greffe de moelle et de thérapie cellulaire (SFGM-TC).

Informed consent is not restricted to clinical research and must be applied to high-risk care such as hematopoietic stem cell transplantation. If standardized informed consent might improve inequalities in medical practices between different transplantation centers, it is strongly recommended that it be adapted with an honest dialogue between physicians and patients and physicians and donors. In an attempt to harmonize clinical practices among French hematopoietic stem cell transplantation centers, the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC) held its sixth annual workshop series in September 2015 in Lille. This event brought together practitioners from across the country. The purpose of this paper is to highlight the French law concerning patients' rights and ethical practices for an informed consent process to be applied to care or research.

Personalised Multi-Criterial Online Decision Support for Siblings Considering Stem Cell Donation: An Interactive Aid.

Person-centred decision support combines the best available information on the considerations that matter to the individual, with the importance the person attaches to those considerations. Nurses and other health professionals can benefit from being able to draw on this support within a clinical conversation. A case study and storyline on four siblings facing a transplant coordinator's call to donate stem cells to their brother [1] is 'translated' and used to demonstrate how an interactive multi-criteria aid can be developed for each within a conversational mode. The personalized dialogue and decision aid are accessible online for interaction. Each sibling's decision exemplifies the communication including physical and psychosocial complexities within any decision cascade from call-to-test and to donate, if compatible. A shared template can embrace the informational and ethical aspects of a decision. By interactive decision support within a clinical conversation, each stakeholder can gain a personalised opinion, as well as increased generic health decision literacy [2].