Abstract

INTRODUCTION

Improving the consent rate for deceased organ donation is an essential component in increasing the availability of organs for transplantation. By its very nature, consent for organ donation is far more complex than most other medical procedures (1). The removal of organs from a deceased donor can be done only under the guiding principles regarding organ donation and transplantation, principles enunciated in international and national legislation. Two types of consent systems can be distinguished: informed consent and presumed consent. An important operational aspect of consent systems is how it is obtained (2).

In Romania there is an Opt-in (informed or voluntary consent) donation system, which in­volves individuals’ explicit affirmative action to become donors by registering their will during their lifetime in the donor register or through the consent of family members if they did not express their desire to become donors during their lifetime (3, 4).

The National Transplant Agency intervenes in coordinating, supervising, approving, implemen­ting legal provisions and authorizing the centers involved in the donation and transplantation acti­vity. At the national level, the National Transplant Agency established six regional offices and 33 accredited centers for the activity of identifying and declaring brain-dead potential donors (5). These centers are assigned to the regional offices and are accredited by the National Transplant Agency (6).

Family refusal for organ donation is a limiting factor for transplant activity. There are several reasons for refusing organ donation: lack of understanding of the diagnosis of brain death, lack of knowledge about the deceased person's wishes, inadequate family interviews, mainte­nance of bodily integrity and religious issues, among others. In general, the causes of family refusal vary by region. Crucial variables such as race, ethnicity and religion make it difficult to maintain a firm strategy for increasing family consent based on patterns of reasons for refusal (5, 7). It is important to note that someone who does not accept the diagnosis of brain death will not be willing to opt for organ donation (8).

MATERIALS AND METHODS

Study design

A retrospective descriptive study, covering data from 1 January 2014 to 31 December 2023, was carried out in the intensive care unit of the Emergency Clinical County Hospital of Bihor, one of the recognized facilities engaged in organ donation and transplantation from Romania. All data were obtained from the Transplant Coordinator of the Emergency Clinical County Hospital of Bihor in April 2024. All potential and actual deceased donors were included in our research. The potential donor is defined by us as a patient whose clinical condition is suspected of fulfilling brain-death criteria, and the actual deceased organ donor as a patient declared brain death who fulfills all medical criteria and legal requirements for organ donation. For a successful identification and conversion of a potential donor to an actual deceased donor, the following requirements must be met: the patient fulfills the criteria for the diagnosis of brain death, the family gives consent for organ donation, there are no medical contraindications for organ and tissue donation, and clinical condition is stable until the organ retrieval procedure. Our main objectives were to summarize the total number of potential and actual deceased donors, their yearly characteristics and the organ and tissue donation types performed. Furthermore, we compared the organ donors provided by the Emergency Clinical County Hospital of Bihor as integrated statistics of the Romanian national donation rates for the mentioned period.

Statistical analysis

We conducted descriptive statistical analyses using IBM SPSS Statistics 29 software. Data were expressed as a count and percentage.

RESULTS

Solid organ and tissue donation activity in the Emergency Clinical County Hospitalof Bihor

During a period of 10 years, between 2014 and 2023, there were 488 potential and actual deceased donors [291 (59.6%) males and 197 (40.4%) females] with a mean age of 57.85 (range 2-90, S.D. 15.99). Of these, 355 (72.7%) were potential donors and 133 (27.3%) actual deceased donors. Figure 1 shows the evolution of the number of actual deceased donors and potential donors from 2014 to 2023. Among the 133 actual deceased donors, 20 were registered in 2015, followed by 19 in 2023, 18 in 2014, 15 in 2016 as well as in 2020, 14 in 2019, eight in 2017 as well as in 2022 and four in 2021. Among the 355 potential donors, 57 were recorded in 2014, followed by 41 in 2018, 39 in 2016, 38 in 2017, 35 in 2015, 34 in 2019, 31 in 2021, 29 in 2020 and 27 in 2022.

Of the 488 potential and actual deceased donors, 17 (3.5%) were pediatric donors, of which nine (6.8%) were actual deceased donors, and the remaining 471 (96.5%) were non-pe­diatric donors. Among the non-pediatric donors, 26 (5.3%) were between the ages of 19 and 35, of which eight (6%) were actual deceased donors; 85 (17.4%) were aged between 36 and 50 years, of which 39 (29.3%) were actual de­ceased donors; 267 (54.7%) were aged between 51 and 70 years, of which 71 (53.4%) were actual deceased donors; 93 (19.1%) were aged between 71 and 90 years, of which 6 (4.5%) were actual deceased donors. The number, mean age and sex of potential and actual deceased donors can be seen in Table 1.

Among the 488 potential and actual deceased donors, the majority had the Rhesus factor 439 (90%), of which 113 (85%) were actual deceased donors and 49 (10%) Rh negative, of which 20 (15%) were actual deceased donors. Regarding blood groups, the most frequently encountered one was Group A, with 202 (41.4%) carriers, of which 54 (40.6%) were actual deceased donors, followed by Group O, with 186 (38.1%) carriers, of which 50 (37.6%) were actual deceased donors, Group B, with 71 (14.5%) carriers, of which 17 (12.8%) were actual de­ceased donors, and Group AB, with 29 (5.9%) carriers, of which 12 (9%) were actual deceased donors.

Among the 355 potential donors, 194 (39.8%) were hemodynamically unstable, 33 (6.8%) were excluded based on medical criteria, three (0.6%) did not receive forensic consent from the medical examiner and one donor (0.2%) was uniden­tifiable. Refusal to donate by the donor's family members was recorded in 124 (25.4%) potential donors. Medical and non-medical refusal of potential donors can be seen in Table 2.

A total of 143 solid organs and 91 tissues were procured through 219 surgical procedures among the 133 actual deceased donors. Of the surgical procedures performed, 15 (6.84%) involved the procurement of a single organ for transplantation, 113 (51.59%) consisted of the procurement of at least two organs for transplantation (multi-organ procurement) and 91 (41.55%) consisted of tissue procurement. The number of surgical procurement procedures, depending on the year, is shown in Table 3.

The majority of solid organs procured came from multi-organ retrieval procedures. The most frequently procured organ was the kidney (paired organ) (116 samples), followed by the liver (111 samples), heart (10 samples), pancreas (four samples) and lungs (two samples). From the category of tissues sampled, the most common were cornea (78 samples), followed by bone/tendon (16 samples) and skin (six samples).

In 2014, 30 solid organs and 15 tissue samplings were procured from 18 actual deceased donors; in 2015, 31 solid organs and 15 tissue samplings were procured from 20 actual deceased donors; in 2016, 28 solid organs and nine tissue samplings were procured from 15 actual deceased donors; in 2017, 12 solid organs and eight tissue samplings were procured from eight actual deceased donors; in 2018, 25 solid organs and eight tissue samplings were procured from 12 actual deceased donors; in 2019, 29 solid organs and seven tissue samplings were procured from 14 actual deceased donors; in 2020, 32 solid organs and 10 tissues samplings were procured from 15 actual deceased donors; in 2021, eight solid organs and eight tissues samplings were procured from four actual deceased donors; in 2022, 13 solid organs and two tissue samplings were procured from eight actual deceased donors; in 2023, 38 solid organs and five tissue samplings were procured from 19 actual deceased donors. Table 4 shows the num­ber and type of solid organs and tissue procured from actual deceased donors, depending on the year.

Solid organ and tissue donation activity at the Emergency Clinical County Hospital of Bihor as integrated statistics of the Romanian national donation rates

From 2014 to 2023, Romania registered 870 actual deceased organ donors, corresponding to 4.4 deceased organ donors per million of popu­lation (pmp) (9). The highest rate of actual deceased organ donors was registered in 2014 (138 donors), and the lowest rate in 2021 (47 do­nors) (Figure 2).

Out of 870 actual deceased organ donors, 133 (15.28%) came from the Emergency Clinical County Hospital of Bihor, one of the recognized facilities engaged in organ donation and transplantation from Romania. The number of actual deceased donors procured by the Emergency Clinical County Hospital of Bihor was 13.08% for the year 2014, 17.69% for 2015, 12.09% for 2016, 12.30% for 2017, 18.46% for 2018, 16.47% for 2019, 22.72% for 2020, 8.51% for 2021, 9.41% for 2022 and 23.17% for the year 2023.

DISCUSSION

In Romania, with the functioning of the informed consent system (opt-in), the success of transplant medicine depends on the families' consent to donate organs and tissues from the brain-dead donor. In this study, we explored and identified the factors that can influence the activity of organ and tissue donations from brain dead donors.

Previous research has shown that the pre­sence of an intra-hospital transplant coordinator can facilitate effective interactions between the medical team and the families of potential do­nors, establish a relationship with the family, optimize the timing of discussions about organ donation, coordinate the request and the entire consent process, as well as efficient donor management (10-12).

The results obtained in the current study highlighted the leading causes of exclusion of potential donors, including hemodynamic insta­bi­lity and families' refusal to agree to donate organs and tissues from a brain-dead donor. We are also observing the consequences of the Covid-19 pandemic in this field, which was seri­ously impacted by the lowest number of organ and tissue donors from brain dead donors in 2021 and by the justifiable rapid changes in physical distancing and health policies. In our study, the consent rate for organ and tissue donation was 26.9%; however, we observed an increased refusal rate of 34.8%, which represents one of the most critical barriers for organ donation and transplantation, the reason for whose approach is a priority in the management strategy of the potential donor.

Within the opt-in system, the patient's family plays an essential role in deciding on organ and tissue donation consent. In a previous study conducted in our center (5), we identified the leading causes of refusal for organ donation by the families of ICU patients. The lack of under­standing of the diagnosis of brain death and emotional stress are among the main factors that can negatively influence the decision about the consent for organ donation of a family member. Information campaigns providing correct infor­mation from specialists in the field can positively impact the general population's attitude toward organ donation consent.

CONCLUSION

Between 2014 to 2023, 143 solid organs and 91 tissues were procured through 219 surgical procedures. Most solid organs procured come from multi-organ retrieval procedures (51.59%). The leading medical cause for refusal among potential organ donors was hemodynamic insta­bility (39.8%), and the leading non-medical cause was the donor's family refusal to donate.

A significant percentage – 15.28% (133) – of the total number of actual deceased organ donors registered at the national level (870) were identified in our medical center. The highest percentage of actual deceased donors recorded in our hospital was registered in 2023, with 23.17% (19) of 82 deceased donors nationwide. The highest number of actual deceased donors recorded in our center was in 2015, with 20 do­nors, corresponding to 17.69% of the national 113 actual deceased donors. These numbers indicate the efficient management established by the Emergency Clinical County Hospital of Bihor, which assists in identifying possible brain death donors and ensures logistics control throughout the procurement stage of organ do­nation.

Conflicts of interest: none declared.

Financial support: none declared.

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FIGURE 1.

Evolution of potential and actual deceased donors

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TABLE 1.

Number, mean age and sex of potential and actual deceased donors

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TABLE 2.

Medical and non-medical refusal of potential donors

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TABLE 3.

Surgical procurement proceduresperyear

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TABLE 4.

Organs and tissue procuredperyear

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FIGURE 2.

Evolution of deceased organ donation in Romania between 2014–2023 and the actual deceased donors procured by the Emergency Clinical County Hospital of Bihor

Contributor Information

Petru COTRAU, Faculty of Medicine and Pharmacy, Doctoral School of Biomedical Sciences, University of Oradea, 1 University Street, 410087 Oradea, Romania . Emergency Clinical County Hospital of Bihor, 410169 Oradea, Romania.

Marcel NEGRAU, Emergency Clinical County Hospital of Bihor, 410169 Oradea, Romania. Department of Surgical Disciplines, Faculty of Medicine and Pharmacy, University of Oradea, 1 University Street, 410087 Oradea, Romania.

Viviana HODOSAN, Faculty of Medicine and Pharmacy, Doctoral School of Biomedical Sciences, University of Oradea, 1 University Street, 410087 Oradea, Romania . Emergency Clinical County Hospital of Bihor, 410169 Oradea, Romania.

Adriana VLADU, Faculty of Medicine and Pharmacy, Doctoral School of Biomedical Sciences, University of Oradea, 1 University Street, 410087 Oradea, Romania . Emergency Clinical County Hospital of Bihor, 410169 Oradea, Romania.

Cristian Marius DAINA, Emergency Clinical County Hospital of Bihor, 410169 Oradea, Romania. Psycho-Neurosciences and Recovery Department, Faculty of Medicine and Pharmacy, University of Oradea, 1 University Street, 410087 Oradea, Romania.

Dorel DULAU, Faculty of Medicine and Pharmacy, Doctoral School of Biomedical Sciences, University of Oradea, 1 University Street, 410087 Oradea, Romania . Emergency Clinical County Hospital of Bihor, 410169 Oradea, Romania.

Lucia Georgeta DAINA, Emergency Clinical County Hospital of Bihor, 410169 Oradea, Romania. Psycho-Neurosciences and Recovery Department, Faculty of Medicine and Pharmacy, University of Oradea, 1 University Street, 410087 Oradea, Romania.

Carmen PANTIS, Emergency Clinical County Hospital of Bihor, 410169 Oradea, Romania. Department of Surgical Disciplines, Faculty of Medicine and Pharmacy, University of Oradea, 1 University Street, 410087 Oradea, Romania.

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