FACTORS ASSOCIATED WITH THE HEMATOPOETIC CELL RETRANSPLANT: A CASE-CONTROL STUDY.
Epidemiology; Graft Rejection; Hematopoietic Stem Cell Transplantation; Bone Marrow Transplantation.
This study aims to study cases of hematopoietic stem cell retransplants performed in patients previously transplanted in a referral service for this procedure of high complexity in the state of Rio Grande do Norte. Treatment with hematopoietic stem cells has provided the discovery of new therapeutic possibilities as well as the assessment of the differentiation potential, safety and efficacy of the procedures that use them. Studies that used progenitor cells in their experiments found positive responses to promote the repair of various organs and tissues. These cells are used in Hematopoietic Stem Cell Transplantation (HSCT), characterized by endovenous grafting of Hematopoietic Progenitor Cells (MHC) with the objective of correcting a quantitative or qualitative failure of the bone marrow. TCTH is indicated for the treatment of malignant and non-malignant hematological diseases, in cases of immunodeficiencies, inborn errors of metabolism, in solid tumors, in addition to autoimmune diseases. The MHC used may be collected from bone marrow, peripheral blood, or placental and umbilical cord blood. According to data from the Brazilian Registry of Transplants, in 2013, 2,137 TCTHs were registered in Brazil, of which 359 occurred in the Northeast region, with 46 of these in the state of Rio Grande do Norte (RN). For the success of HSCT it is essential that the infused cells proliferate in the receptor permanently to avoid rejection and that the new immune system received from the donor tolerates the receptor tissues in order to avoid infections, Graft versus Host Disease (GVHD) and other morbidities , which can be serious and fatal. In addition, the immune system should be functioning properly and the stage of the disease, its complications, comorbidities at the time of transplantation, and health care throughout the process should also be considered. Regarding the failure, this has a direct relationship with the procedure, represented by the toxicity of the conditioning regimen, acute or chronic GVHD and relapse, which occurs in 20% of the patients. For the purpose of this study, the condition in which HSCT performed was unable to establish itself in the patient who received it and resolve the initial spinal cord failure and who required retransplantation as a therapeutic condition will be considered as failure. In this context, the present study aims to analyze the factors associated with the failure of HSCT in patients submitted to retransplantation at a referral service in the state of Rio Grande do Norte from 2008 to 2017. The study will be a quantitative approach , of the case-control type, descriptive and analytical. The data will be collected from secondary sources, from the charts of the patients served by the study service and will be analyzed in order to verify the association between the clinical and sociodemographic variables with hematopoietic stem cell retransplantation among patients submitted to HSCT. To calculate the probability of association between the characteristics analyzed and the sex, the Chi-square trend test, the Fisher test and the Mann Whitney test, among others, will be used according to each case. Bivariate and multivariate analyzes will be used to evaluate the association between the selected variables and estimate the magnitude of the Odds Ratio, respectively. For the bivariate analysis we will use the Student's t-test for independent samples, as well as the Mann Whitney U test and the Chi-square test, and for the multivariate analysis will be used the logistic regression, through the Statistic Package for Social Sciences (SPSS®) version 22.0. The level of significance to be adopted will be 0.05. The Research Protocol was submitted to the Research Ethics Committee (CEP) of the Federal University of Rio Grande do Norte (UFRN) and is in ethical appreciation.