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Lung Injury Prevention with Aspirin (LIPS-A): a Protocol for a Multicentre Randomised Clinical Trial in Medical Patients at High Risk of Acute Lung Injury
Introduction: Acute lung injury (ALI) is a devastating condition that places a heavy burden on public health resources. Although the need for effective ALI prevention strategies is increasingly recognised, no effective preventative strategies exist. The Lung Injury Prevention Study with Aspirin (LIPS-A) aims to test whether aspirin (ASA) could prevent and/or mitigate the development of ALI. Methods and analysis LIPS-A is a multicentre, double-blind, randomised clinical trial testing the hypothesis that the early administration of ASA will result in a reduced incidence of ALI in adult patients at high risk. This investigation will enrol 400 study participants from 14 hospitals across the USA. Conditional logistic regression will be used to test the primary hypothesis that early ASA administration will decrease the incidence of ALI. Ethics and dissemination Safety oversight will be under the direction of an independent Data and Safety Monitoring Board (DSMB). Approval of the protocol was obtained from the DSMB prior to enrolling the first study participant. Approval of both the protocol and informed consent documents were also obtained from the institutional review board of each participating institution prior to enrolling study participants at the respective site. In addition to providing important clinical and mechanistic information, this investigation will inform the scientific merit and feasibility of a phase III trial on ASA as an ALI prevention agent. The findings of this investigation, as well as associated ancillary studies, will be disseminated in the form of oral and abstract presentations at major national and international medical specialty meetings. The primary objective and other significant findings will also be presented in manuscript form. All final, published manuscripts resulting from this protocol will be submitted to Pub Med Central in accordance with the National Institute of Health Public Access Policy
Measuring the impact of ambulatory red blood cell transfusion on home functional status: study protocol for a pilot randomized controlled trial
SPIRIT 2013: SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Checklist for clinical trial protocols. (DOCX 65 kb
Sex difference and intra-operative tidal volume: Insights from the LAS VEGAS study
BACKGROUND: One key element of lung-protective ventilation is the use of a low tidal volume (VT). A sex difference in use of low tidal volume ventilation (LTVV) has been described in critically ill ICU patients.OBJECTIVES: The aim of this study was to determine whether a sex difference in use of LTVV also exists in operating room patients, and if present what factors drive this difference.DESIGN, PATIENTS AND SETTING: This is a posthoc analysis of LAS VEGAS, a 1-week worldwide observational study in adults requiring intra-operative ventilation during general anaesthesia for surgery in 146 hospitals in 29 countries.MAIN OUTCOME MEASURES: Women and men were compared with respect to use of LTVV, defined as VT of 8 ml kg-1 or less predicted bodyweight (PBW). A VT was deemed 'default' if the set VT was a round number. A mediation analysis assessed which factors may explain the sex difference in use of LTVV during intra-operative ventilation.RESULTS: This analysis includes 9864 patients, of whom 5425 (55%) were women. A default VT was often set, both in women and men; mode VT was 500 ml. Median [IQR] VT was higher in women than in men (8.6 [7.7 to 9.6] vs. 7.6 [6.8 to 8.4] ml kg-1 PBW, P < 0.001). Compared with men, women were twice as likely not to receive LTVV [68.8 vs. 36.0%; relative risk ratio 2.1 (95% CI 1.9 to 2.1), P < 0.001]. In the mediation analysis, patients' height and actual body weight (ABW) explained 81 and 18% of the sex difference in use of LTVV, respectively; it was not explained by the use of a default VT.CONCLUSION: In this worldwide cohort of patients receiving intra-operative ventilation during general anaesthesia for surgery, women received a higher VT than men during intra-operative ventilation. The risk for a female not to receive LTVV during surgery was double that of males. Height and ABW were the two mediators of the sex difference in use of LTVV.TRIAL REGISTRATION: The study was registered at Clinicaltrials.gov, NCT01601223
Red Blood Cell Storage Lesion
The past two decades have witnessed increased scrutiny regarding efficacy and risk of the once unquestioned therapy of red blood cell (RBC) transfusion. Simultaneously, a variety of changes have been identified within the RBC and storage media during RBC preservation that are correlated with reduced tissue oxygenation and transfusion-associated adverse effects. These alterations are collectively termed the storage lesion and include extensive biochemical, biomechanical, and immunologic changes involving cells of diverse origin. Time-dependent falls is 2,3-diphosphoglycerate, intracellular RBC adenosine triphosphate, and nitric oxide have been shown to impact RBC deformability and delivery of oxygen to the end-organ. The accumulation of biologic response modifiers such as soluble CD40 ligand (sCD40L), lysophosphatidylcholine (lyso-PC), and Regulated on Activation, Normal T-cell Expressed and Secreted (RANTES) have been associated with altered recipient immune function as well. This review will address the alterations occurring within the RBC and storage media during RBC preservation and will address the potential clinical consequence thereof
Fresh Red Blood Cell Transfusion and Short-Term Pulmonary, Immunologic, and Coagulation Status A Randomized Clinical Trial AT A GLANCE COMMENTARY Scientific Knowledge on the Subject
Rationale: Transfusion-related pulmonary complications are leading causes of morbidity and mortality attributed to transfusion. Observational studies suggest an important role for red blood cell (RBC) storage duration in these adverse outcomes. Objectives: To evaluate the impact of RBC storage duration on shortterm pulmonary function as well as immunologic and coagulation status in mechanically ventilated patients receiving RBC transfusion. Methods: This is a double-blind, randomized, clinical trial comparing fresh (<5 d of storage) versus standard issue single-unit RBC transfusion in adult intubated and mechanically ventilated patients. The primary outcome is the change in pulmonary gas exchange as assessed by the partial pressure of arterial oxygen to fraction of inspired oxygen concentration ratio ( Since the first successful attempt at blood storage almost a century ago, advances in extracorporeal red blood cell (RBC) preservation have incrementally prolonged the viability of stored RBCs. With contemporary preservative solutions, the accepted duration of RBC storage has now been extended to 42 days (1). In the past two decades, there has been increased interest in the time-dependent changes in RBC quantity and quality during this storage period. The various changes that occur within both the RBC and storage media during ex vivo preservation have been collectively termed the RBC "storage lesion." Importantly, alterations that occur during the RBC storage process are believed potentially responsible for many of the adverse effects associated with blood product administration (2). Among these concerns is a potentially increased risk of transfusion-related acute lung injury (TRALI) (3-6) as well as risk-adjusted mortality (7-10). Multiple publications have suggested that these associations become more significant with increased duration of RBC storage While the majority of TRALI cases are believed to be the result of an interaction between donor anti-HLA or anti-leukocyte antibodies and the cognate antigen on recipient leukocytes (20), a second "two-hit" model for TRALI has also been described (21). This model suggests that in a "primed" host, infusion of Author Contributions: D.J.K. contributed to the acquisition of data, and analysis and interpretation of the study results. R.K. contributed to the study design and procedures and the acquisition of the data. R.B.W. contributed to the study conception and design as well as the interpretation of the data. G.A.W. contributed to the study procedures and acquisition of the study data. C.M.v.B. contributed to the study conception and design as well as the study procedures. J.L.W. contributed to the study procedures as well as the interpretation of the study results. M.M. contributed to the analysis and interpretation of the data and study results R.D.H. contributed to the study conception and design as well as the interpretation of the study results. O.G. contributed to the study conception and design as well as the analysis and interpretation of the study results. All of the listed authors contributed to drafting and revising the manuscript and all have provided approval to the final version of the submitted manuscript. What This Study Adds to the Field In this investigation, the impact of a single unit of fresh red blood cell transfusion on markers of pulmonary, inflammatory, and coagulation status was similar to the impact seen with the transfusion of a single unit of standard issue red blood cells
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