Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery

IntroductionThe transfusion-related respiratory complications, transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO), are leading causes of transfusion-related morbidity and mortality. At present, there are no effective preventive strategies with red blood cell (RBC) transfusion. Although mechanisms remain incompletely defined, soluble biological response modifiers (BRMs) within the RBC storage solution may play an important role. Point-of-care (POC) washing of allogeneic RBCs may remove these BRMs, thereby mitigating their impact on post-transfusion respiratory complications.Methods and analysisThis is a multicenter randomised clinical trial of standard allogeneic versus washed allogeneic RBC transfusion for adult patients undergoing cardiac surgery testing the hypothesis that POC RBC washing is feasible, safe, and efficacious and will reduce recipient immune and physiologic responses associated with transfusion-related respiratory complications. Relevant clinical outcomes will also be assessed. This investigation will enrol 170 patients at two hospitals in the USA. Simon’s two-stage design will be used to assess the feasibility of POC RBC washing. The primary safety outcomes will be assessed using Wilcoxon Rank-Sum tests for continuous variables and Pearson chi-square test for categorical variables. Standard mixed modelling practices will be employed to test for changes in biomarkers of lung injury following transfusion. Linear regression will assess relationships between randomised group and post-transfusion physiologic measures.Ethics and disseminationSafety oversight will be conducted under the direction of an independent Data and Safety Monitoring Board (DSMB). Approval of the protocol was obtained by the DSMB as well as the institutional review boards at each institution prior to enrolling the first study participant. This study aims to provide important information regarding the feasibility of POC washing of allogeneic RBCs and its potential impact on ameliorating post-transfusion respiratory complications. Additionally, it will inform the feasibility and scientific merit of pursuing a more definitive phase II/III clinical trial.RegistrationClinicalTrials.gov registration number isNCT02094118(Pre-results).

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MP50: Vaping, tobacco and cannabis among patients presenting to the emergency department: a cross-sectional study

CJEM ◽

10.1017/cem.2020.198 ◽

2020 ◽

Vol 22 (S1) ◽

pp. S60-S61

Author(s):

K. Zhou ◽

D. Junqueira ◽

S. Couperthwaite ◽

J. Meyer ◽

B. Rowe

Keyword(s):

Emergency Department ◽

Lung Injury ◽

Tobacco Smoking ◽

Respiratory Symptoms ◽

Cannabis Use ◽

Categorical Variables ◽

Continuous Variables ◽

Cannabis Smoking ◽

Lung Health ◽

Respiratory Conditions

Introduction: Inhaled toxins from tobacco smoking, cannabis leaf smoking as well as vaping/e-cigarette products use are known causes of cardio-respiratory injury. While tobacco smoking has decreased among Canadian adults, there are now several other forms of legal inhalant products. While legal, the evidence of benefit and safety of vaping is limited. Of concern, cases of e-cigarette or vaping products use associated lung injury (EVALI) have been accumulating in the U.S. and now in Canada. Despite this, very little is known about the inhalation exposure of emergency department (ED) patients; this study was designed to explore lung health in the ED. Methods: We investigated the prevalence of exposure to vaping, tobacco and cannabis among patients presenting to a Canadian ED from July to November 2019. Ambulatory (CTAS 2 to 5), stable, adult (≥ 17 years) patients were prospectively identified and invited to complete a survey addressing factors related to lung health (previous diagnosis of respiratory conditions and respiratory symptoms at the ED presentation) and information on current exposure to vaping, tobacco and cannabis smoking. Categorical variables are reported as frequencies and percentages; continuous variables are reported as medians with interquartile range (IQR). The study was approved by the Health Research Ethics Board. Results: Overall, 1024 (71%) of 1433 eligible patients completed the survey. The median age was 43.5 (IQR: 29, 60), and 51% were female. A total of 351 (31%) participants reported having been previously diagnosed with ≥1 respiratory conditions, and 177 (17%) were visiting the ED as a result of ≥1 respiratory symptoms (e.g., cough, shortness of breath, wheezing). Daily tobacco smoking was reported by 190 (19%), and 83 (8%) reported using vaping/e-cigarette products. Cannabis use within 30 days was described by 80 (15%) respondents. Exposure to tobacco and vaping products was reported by 39 (4%) participants, 63 (6%) reported using tobacco in combination with cannabis smoking, and 3% reported combining vaping and cannabis use. Conclusion: Patients seeking care in the ED are exposed to a large quantity of inhaled toxins. Vaping products, considered the cause of the most recent epidemic of severe lung injury, are used in isolation and in combination with other smoking products in Canada. These exposures should be documented and may increase the risk of lung health injuries and exacerbations of chronic respiratory conditions.

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Long-term effects of remote ischaemic preconditioning in high risk patients undergoing cardiac surgery: follow-up of a randomised clinical trial

Intensive Care Medicine Experimental ◽

10.1186/2197-425x-3-s1-a411 ◽

2015 ◽

Vol 3 (S1) ◽

Author(s):

A Zarbock ◽

J Kellum ◽

H Van Aken ◽

C Schmidt ◽

S Martens ◽

...

Keyword(s):

Clinical Trial ◽

Cardiac Surgery ◽

High Risk ◽

Randomised Clinical Trial ◽

Ischaemic Preconditioning ◽

Long Term Effects ◽

Risk Patients ◽

Remote Ischaemic Preconditioning

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A Cohort of Gender-Based Outcomes in Hepatitis B and C after Cardiac Surgery

Liaquat National Journal of Primary Care ◽

10.37184/lnjpc.2707-3521.1.25 ◽

2020 ◽

Keyword(s):

Cardiac Surgery ◽

Cardiopulmonary Bypass ◽

Hepatitis B ◽

Categorical Variables ◽

Continuous Variables ◽

Cardiopulmonary Bypass Time ◽

Predictors Of Mortality ◽

Significant Difference ◽

Gender Based ◽

And Gender

Objective: Our research article aimed to determine if six-month mortality amongst hepatitis B and C patients undergoing cardiac surgery varied according to gender, post-operatively. Secondarily, we highlighted the significant differences among the two genders in their pre-operative, operative, and post-operative characteristics and deduced significant predictors of mortality. Methods: We obtained approval from the International Review Board of the Dow University of Health Sciences, and conducted a retrospective study targeting hepatitis B and C patients who had undergone cardiac surgery between January 2013 to October 2018 at the Ruth Pfau Civil Hospital, Karachi, Pakistan. The data was analysed using the Statistical Package for Social Sciences (Version 20.0). The population was divided into two groups, based on gender. Chi-squared test was used to compare categorical variables and odd ratios with 95% confidence interval were also computed. Differences in continuous variables were assessed using independent T-test or Mann-Whitney U test. Results: There was no significant difference in six-month mortality between the genders, with a 22.5% mortality in males and 20.0% mortality in females. Post-operatively, males had higher creatinine (p=0.003) levels but females tended to have a longer ward stay (p=0.032). On multivariate logistic regression, duration of intubation (aOR=1.131, 95% CI: 1.002-1.275), cardiopulmonary bypass time (aOR=1.030, 95% CI: 1.002-1.059) and duration of ward stay (aOR=1.100, 95% CI: 1.031-1.175) were found to be significant predictors of mortality. Conclusion: There is no association between six-month mortality and gender among hepatitis B and C patients undergoing cardiac surgery. Additionally, duration of intubation, cardiopulmonary bypass time and duration of ward stay are significant predictors of six-month mortality.

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