Sibele Schuantes’s bio

Sibele Schuantes, Registered Nurse, Master of Health Science, PhD Student at Federal University of São Paulo (UNIFESP) – Brazil. Member of Study Group on Organ and Tissue Donation for Transplants (GEDOTT); Member of Allied Research in Donation and Transplantation (ARDOT); International Member of Canadian Donation and Transplantation Research Program (CDTRP); Member of Brazilian Association of Organ Transplantation (Associação Brasileira de Transplante de Órgãos – ABTO).


Time elapsed between cells, tissues and organs donation and transplantation and adverse events detection

Bartira de Aguiar Roza; Janine Schirmer

Introduction: Adverse events in cells, tissues and organs donation and transplantation are defined as any unfavorable situation that can cause damage to the recipient. A previous study developed in Brasil, characterized causes of adverse events. However, discrepancies were observed regarding the time elapsed between the procedure (donation or transplant), detection and notification of adverse events. Therefore, this question arose: how long after transplant can the unfavorable situation be considered an adverse event?

Objective: To discuss time between transplant and detection of adverse events notified in São Paulo – Brazil.

Method: Descriptive study with quantitative approach. Data provided by Transplantation Central of São Paulo from the “Individual notification form of adverse reactions in Biovigilance” between 2016 and 2019. Analysis was performed using descriptive statistics.

Results: Fifty-two notification were analyzed, and three categories were formed: 1) adverse events detected on the same day of transplant: eight; 2) adverse events detected between one week and 548 days after transplant: 40 and 3) adverse events detected two years after transplant: four. Regarding the third category, events were detected three, five, 11 and 12 years after transplant. All imputed as discarded and classified as moderate. The nature of the events was hematopoietic stem cells transplant and the cause of notification, neoplasm.

Conclusion: The discussion on the topic is beginning, however, it is important. Since the clinical management of transplant recipients as well as the comprehension about what is considered adverse event and is the natural course of the patient’s life, can impact in clinical decision-making, public policies, and patient safety research. This study highlights the need to investigate related factors to adverse events, especially, the time between the transplant procedure and adverse event detection, to stablish clinical guideline.