Background:The ideal treatment of coronavirus disease (COVID)-19 has yet to be defined, but convalescent plasma (Co-Pla) has been successfully employed. Objective: The objective of the study was to study the safety and outcomes of the administration of CoPla to individuals with severe COVID-19 in an academic medical center. Methods: Ten patients were prospectively treated with plasma from COVID-19 convalescent donors. Results: Over 8 days, the sequential organ failure assessment score dropped significantly in all patients, from 3 to 1.5 (p = 0.014); the Kirby index (PaO 2 /FiO 2 ) score increased from 124 to 255, (p < 0.0001), body temperature decreased significantly from 38.1 to 36.9°C (p = 0.0058), and ferritin levels also dropped significantly from 1736.6 to 1061.8 ng/ml (p = 0.0001). Chest X-rays improved in 7/10 cases and in 6/10, computerized tomography scans also revealed improvement of the lung injury. Decreases in C-reactive protein and D-dimer levels were also observed. Three of five patients on mechanical ventilation support could be extubated, nine were transferred to conventional hospital floors, and six were sent home; two patients died. The administration of CoPla had no side effects and the 24-day overall survival was 77%. Conclusions: Although other treatments were also administered to the patients and as a result data are difficult to interpret, it seems that the addition of CoPla improved pulmonary function. (REV INVEST CLIN. 2020;72(3):159-64)
Introduction: Hematopoietic stem cell transplantation (HSCT) has been widely employed for autoimmune disorders under myeloablative and non-myeloablative regimens. The main indication for HSCT in this setting is multiple sclerosis (MS) in its relapsing-remitting form and related disorders such as neuromyelitis optica or clinical isolated syndrome. Results have varied, but response rates and prognostic features are still unkown along the spectrum of disease and conditioning regimens. Methods: People with MS (PwMS) autografted from March 2015 to March 2020 with a reduced intensity regimen (Cy/G-CSF + Rituximab) (NCT 02674217), were followed longitudinally every 3 months to assess the Expandable Disease Status Scale (EDSS). All patients with complete follow-up data were included in this study and two different cohorts were made according to PwMS that were followed by 12 or 24 months. The primary outcome was improvement or stabilization of EDSS at 12 months and 24 months. All potential prognostic factors were collected from electronic medical record of patients with complete sociodemographic, clinical and laboratory data. In order to identify prognostic factors related to responses, univariate analyses were carried out with logistic regression; variables that showed a p value <0.15 were included in the multivariate analyses (using age, sex, type of MS, previous history of EDSS as covariates) with logistic regression. All patients signed a consent to authorize intervention and contact for follow-up and the protocol study was approved by the Institutional Ethics Committee. Results: Two cohorts were formed according to follow-up periods. Cohort 1 (12 months follow-up) comprised of 200 pwMS, 133 (66.5%) being female and 47 (33.5%) male. Their features are shown in Figure 1A. Cohort 2 (24 months follow-up) was formed by 93 pwMS, 60 (64.5%) being female and 33 (35.5%) male. Their features are shown in Figure 1B. In cohort 1, 149 pwMS (74.5%) had a response while 51 (25.5%) did not. Mean change of EDSS between baseline and 12 months post-HSCT was -0.42 (range -7 to 4). In cohort 2, 54 patients (58%) had a response while 39 (42%) did not. Mean change of EDSS between baseline and 24 months post-HSCT was -0.02 (range -4 to 7). In cohort 1, baseline EDSS ≥4 was identified as a predictor of 12 months response in multivariate analysis (OR 0.02, p 0.02, 95% CI 0.1- 0.8). Also, early response at 3 months post-HSCT in the univariate (OR 8.5, p <0.0001, 95% CI 3.9 - 18.4) and multivariate (OR 10.3, p <0.0001, 95% CI 4.6 - 23.2) analyses presented as a predictor of 12 months response. In cohort 2, early response at 6 months predicted response at 24 months post-HSCT in the univariate (OR 16.1, p <0.0001, 95% CI 4.8 - 53.6) and multivariate analysis (OR 28, p <0.0001, 95% CI 5.8 - 133.8). Furthermore, duration of disease >10 years showed an association with a negative response at 24 months as well in the univariate (OR 0.3, p 0.008, 95% CI 0.1 - 0.7) and multivariate analyses (OR 0.1, p 0.002, 95% CI 0.04 - 0.5). These results are shown in Figure 1C and 1D. Conclusions: Early response at 3 or 6 months may be robust measures that could translate in long term improvement or stabilization of disease. Although the effects showed in this study are profound and were replicated on two cohorts, these results should be interpreted with caution and a longer follow-up could confirm these findings. Disclosures No relevant conflicts of interest to declare.
Introduction One important aspect of quality assurance in transplantation relates to the maintenance of central venous access (CVA), especially in outpatient conditions in which patients have a higher degree of activity and manipulation of CVA tends to be more frequent. A comprehensive program oriented to prevent and control complications related to CVA insertion, maintenance and removal is thought to be a highly effective strategy to improve safety outcomes. Methods A retrospective study evaluating complications related to central venous access (CVA) in patients undergoing hematopoietic stem cell transplantation (HSCT) was conducted using electronic medical records (EMR) at our center. Laboratory and radiology reports were collected in order to identify complications related to CVA. Patients from May 2015 to July 2021 were included in the study. As per local protocol, insertion of Mahurkar catheter for cell collection is conducted by an experienced surgeon under general anesthesia on day -3 and after a short-stay (6 hours) in hospital patients are discharged. On day -2, cell collection is accomplished following all cautionary measures and removal of catheter is done on day -1. Maintenance and care of CVA is guided by standardized protocols related to cleaning, manipulation, blood sample collection and removal. All patients signed a consent to participate in the study and the study protocol was approved by Clínica Ruiz IRB. To be considered as statistically significant, results had to display a two-sided p value <0.05. Results A total of 1088 patients recruited since May 2015 were included in the study. Main indication for auto-HSCT was multiple sclerosis with 1066 (98%), followed by chronic inflammatory demyelinating polyneuropathy with 16 (1.5%) and 5 (0.5%) patients with other autoimmune disorders. Median age of donors was 46 (40 - 54) years. Median dose of CD34 + cells x10 6/kg infused per patient was 7.0 (3.7 - 11.3) and the median of collection events per patient was 1 (1 - 2). Cell collection was accomplished via apheresis in (99.5%) of patients, of those CVA was used as collection site in 998 (92%) patients, while a change for peripheral venous access occurred in 85 (8%) patients, due to different reasons, most frequent being any type of CVA obstruction in 62 (83%) of donors. Pneumothorax occurred in 11 (1.1%) patients in whom CVA was used for collection. All cases were successful managed with pleural drainage and hospital admission longer than 24 hours was required for 3 (27%). Furthermore, catheter-related bloodstream infections were identified in 3 (0.3%) patients whom were admitted and treated with broad-spectrum antibiotics and discharged with no further events. There were no misplacement, thrombotic- nor hemorrhagic-related events in patients with CVA. A multifactorial analysis revealed that relevant factors such as, age, sex and type of disease were not correlated with any type of CVA-related complications. Conclusions We have shown that prevention and control of complications related to CVA at our campuses are highly effective. The proportion of patients experiencing a CVA-related complication was minimal in comparison with other experiences. Disclosures Gomez-Almaguer: Roche: Honoraria, Speakers Bureau; Takeda: Honoraria, Speakers Bureau; Bristol-Myers-Squibb: Honoraria, Speakers Bureau; Janssen: Honoraria, Speakers Bureau.
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