Hemostatic efficacy of pathogen-inactivated vs untreated platelets: a randomized controlled trial.

Pathogen inactivation of platelet concentrates reduces the risk for blood-borne infections. However, its effect on platelet function and hemostatic efficacy of transfusion is unclear. We conducted a randomized noninferiority trial comparing the efficacy of pathogen-inactivated platelets using riboflavin and UV B illumination technology (intervention) compared with standard plasma-stored platelets (control) for the prevention of bleeding in patients with hematologic malignancies and thrombocytopenia. The primary outcome parameter was the proportion of transfusion-treatment periods in which the patient had grade 2 or higher bleeding, as defined by World Health Organization criteria. Between November 2010 and April 2016, 469 unique patients were randomized to 567 transfusion-treatment periods (283 in the control arm, 284 in the intervention arm). There was a 3% absolute difference in grade 2 or higher bleeding in the intention-to-treat analysis: 51% of the transfusion-treatment periods in the control arm and 54% in the intervention arm (95% confidence interval [CI], -6 to 11; P = .012 for noninferiority). However, in the per-protocol analysis, the difference in grade 2 or higher bleeding was 8%: 44% in the control arm and 52% in the intervention arm (95% CI -2 to 18; P = .19 for noninferiority). Transfusion increment parameters were ∼50% lower in the intervention arm. There was no difference in the proportion of patients developing HLA class I alloantibodies. In conclusion, the noninferiority criterion for pathogen-inactivated platelets was met in the intention-to-treat analysis. This finding was not demonstrated in the per-protocol analysis. This trial was registered at The Netherlands National Trial Registry as #NTR2106 and at www.clinicaltrials.gov as #NCT02783313.

Remote Patient Monitoring in Adults Receiving Transfusion or Infusion for Hematological Disorders Using the VitalPatch and accelerateIQ Monitoring System: Quantitative Feasibility Study.

BACKGROUND: Frequent vital sign monitoring during and after transfusion of blood products and certain chemotherapies or immunotherapies is critical for detecting infusion reactions and treatment management in patients. Currently, patients return home with instructions to contact the clinic if they feel unwell. Continuous monitoring of vital signs for hematological patients treated with immunotherapy or chemotherapy or receiving blood transfusions using wearable electronic biosensors during and post treatment may improve the safety of these treatments and make remote data collection in an outpatient care setting possible. OBJECTIVE: This study aimed to evaluate patient experiences with the VitalPatch wearable sensor (VitalConnect) and to evaluate the usability of data generated by the physIQ accelerateIQ monitoring system for the investigator and nurse. METHODS: A total of 12 patients with hematological disorders receiving red blood cell transfusions, an intravenous (IV) proteasome inhibitor, or an IV immunotherapy agent were included in the study and wore the VitalPatch for 12 days. Patients completed questionnaires focusing on wearability and nurses completed questionnaires focusing on the usability of the VitalPatch. RESULTS: A total of 12 patients were enrolled over 9 months, with 4 receiving red blood cell transfusions, 4 receiving IV proteasome inhibitors, and 4 receiving IV immunotherapy. These patients were treated for diseases such as multiple myeloma, myelodysplastic syndrome, and non-Hodgkin lymphoma. Of these patients, 83% (10/12) were aged 60 years and older. A total of 4 patients (4/12, 33%) withdrew from the study (3 because of skin irritation and 1 because of patch connection issues). Patients wore biosensor patches at baseline and for 1-week post administration. Patient-reported outcomes (PROs) were collected at baseline, day 1, day 5, and day 8. No difference in the PRO was observed when nurses or patients applied the patch. PRO data indicated minimal impact on the patient's life. Ease of use, influence on sleep, impact on follow-up of health, or discomfort with continuous monitoring did not change between baseline and day 8. Changes in PRO were observed on day 5, where a 20% (2/10) increase in skin irritation was reported. Withdrawals because of skin irritation were reported in all cases when wearing the second patch. Nurses reported the placement of the VitalPatch to be easy and felt measurements to be reliable. CONCLUSIONS: Generally, the VitalPatch was well tolerated and shown to be an attractive device because of its wearability and low impact on daily activities in patients, therefore making it suitable for implementation in future studies.

Variable BCG efficacy in rhesus populations: Pulmonary BCG provides protection where standard intra-dermal vaccination fails.

M.bovis BCG vaccination against tuberculosis (TB) notoriously displays variable protective efficacy in different human populations. In non-human primate studies using rhesus macaques, despite efforts to standardise the model, we have also observed variable efficacy of BCG upon subsequent experimental M. tuberculosis challenge. In the present head-to-head study, we establish that the protective efficacy of standard parenteral BCG immunisation varies among different rhesus cohorts. This provides different dynamic ranges for evaluation of investigational vaccines, opportunities for identifying possible correlates of protective immunity and for determining why parenteral BCG immunisation sometimes fails. We also show that pulmonary mucosal BCG vaccination confers reduced local pathology and improves haematological and immunological parameters post-infection in animals that are not responsive to induction of protection by standard intra-dermal BCG. These results have important implications for pulmonary TB vaccination strategies in the future.

Toxoplasma gondii infection in animal-friendly pig production systems.

PURPOSE: Consumption of undercooked pork meat products has been considered a major risk factor for contracting toxoplasmosis in humans. Indoor farming and improved hygiene have drastically reduced Toxoplasma infections in pigs over the past decades. Whether introduction of animal-friendly production systems will lead to a reemergence of Toxoplasma infections in pigs is not yet known. Investigating this possibility was the purpose of this study. METHODS: Blood was obtained from pigs raised for slaughter and tested for Toxoplasma antibodies by using latex agglutination and indirect immunofluorescence testing, with confirmation by immunoblotting. RESULTS: None of the slaughter pigs (n = 621) from conventional farms (n = 30) were positive, whereas 38 (2.9%) of 1295 animals from animal-friendly systems tested positive (n = 33 farms; 13 [39%] farms positive). CONCLUSIONS: The following conclusions may be derived from this study: Conventionally (indoors) raised pigs are free from Toxoplasma infection, and (2) animal-friendly production systems may lead to a reemergence of Toxoplasma infections, although many of these farms remain Toxoplasma free. Slaughterhouse monitoring of pigs from animal-friendly production systems combined with on-farm prevention strategies should be applied to ensure safety for consumers of the meat products obtained from these animals.