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Haemoglobin vesicles (HbVs) (product name, NMU-HbVs [Nara Medical University-Haemoglobin Vesicles]), which contain purified human haemoglobin encapsulated within liposomes, have been developed as a potential alternative to blood transfusions in emergency situations. A previous phase I study examined doses up to 100 mL in 11 healthy volunteers. Here, we describe the protocol for a phase Ib study, wherein we will evaluate the safety and pharmacokinetics of NMU-HbV in healthy Japanese adults.
This single-centre, open-label, dose-escalation study will enrol 16 healthy volunteers divided into four cohorts. Planned doses are 100 mL for cohorts 1 and 2, 200 mL for cohort 3 and 400 mL for cohort 4, with infusion rates gradually increasing to a maximum of 5.0 mL/min. The primary endpoint will be safety, which will be assessed as the incidence of adverse events within 14 days and significant clinical changes within 72 hours after administration. Safety evaluations will include subjective symptoms, vital signs, electrocardiograms and laboratory test results compared with the baseline. The secondary endpoint will be pharmacokinetics, which will be assessed as changes in NMU-HbV concentration immediately after infusion until day 4 to determine the maximum blood concentration, time to reach the maximum blood concentration, area under the blood concentration-time curve and elimination half-life. This study will provide data on the safety and pharmacokinetic profiles of NMU-HbV at doses up to 400 mL. The findings are expected to support the further development of NMU-HbV as a viable alternative to emergency transfusions.
The study protocol was approved by the Institutional Review Board of Nara Medical University on 10 December 2024. Dissemination plans include publishing in peer-reviewed scientific journals and presentation at international conferences.
Japan Registry of Clinical Trials (jRCT2051240249). Registered on 27 January 2025 (https://jrct.mhlw.go.jp/en-latest-detail/jRCT2051240249).
To examine clinical nurses' attitudes towards and self-reported experiences of family nursing in Japan following the relaxation of COVID-19 visitation restrictions. Particular attention is paid to early career nurses whose formative training occurred during visitation bans. The study focused on nurses' negative perceptions and emotional burdens associated with family involvement.
A quantitative-dominant mixed-methods cross-sectional study reported in accordance with the STROBE guideline.
Using a convenience sampling approach, a self-administered, paper-based questionnaire was distributed to clinical nurses in four general hospitals in Japan between January and May 2024. The questionnaire consisted of four parts: demographic and professional background, learning methods related to family nursing, 17 items including negatively valenced statements adapted from the Families' Importance in Nursing Care–Nurses' Attitudes (FINC-NA) scale, and one open-ended question. Quantitative data were analysed using descriptive statistics and t-tests, and qualitative responses were thematically analysed.
Of 1921 nurses invited, 957 responded (response rate: 49.8%), and data from 892 valid responses were analysed. Overall, the nurses demonstrated positive recognition of family nursing as a professional value but also reported lingering emotional burdens and practical challenges when interacting with families. Early-career nurses who began practice during the pandemic showed greater uncertainty and lower affective engagement. Thematic analysis revealed five key themes: relational disruption, emotional stress, moral conflict, reappraisal of family engagement and ongoing barriers.
The findings underscore the need to structurally and educationally reintegrate families into nursing care. Simulation-based training, clear institutional policies and hybrid communication models are essential to rebuild relational continuity and support nurses' emotional and ethical capacity for family nursing.
The findings highlight the need to structurally and educationally reintegrate families into clinical care to address the emotional burden and ambivalence reported by nurses. Organisational support—such as clear visitation policies, simulation-based education and reflective opportunities—can help rebuild nurses' relational competence and confidence in engaging with families. Creating supportive learning environments, including on-the-job mentoring and team-based reflection, may further facilitate the restoration of family nursing.
This study addressed how prolonged COVID-19 visitation restrictions disrupted family nursing practice in Japan, created generational differences in nurses' competencies, and shaped nurses' perceptions of family involvement. Nurses reported emotional strain, feelings of being monitored and lack of time when families were present. Early career nurses showed lower relational engagement, while experienced nurses expressed moral distress. ‘Latent indifference’ was also noted. The findings provide valuable insights for healthcare organisations, nurse educators and policymakers by informing strategies to reintegrate families into patient care, improve discharge planning and strengthen training models.
The STROBE checklist.
No patient or public contribution.
Nos movemos en un mundo complejo que aúna los mayores avances que el conocimiento científico-tecnológico ha aportado a la humanidad, con las peores situaciones de inseguridad a las que ha sido sometido el ser humano, que adquieren dimensiones planetarias como consecuencia de la globalización. Si las enfermeras sabemos que el compromiso con la ciudadanía se acentúa en los momentos de adversidad, lo cierto es que acontecimientos como desastres naturales, accidentes imprevistos de grandes dimensiones, actos terroristas, conflictos armados y en general situaciones que ponen a prueba la supervivencia de los individuos y las colectividades, nos hacen tomar conciencia de la verdadera extensión a la que somos llamadas en nuestra vocación de servicio [fragmento de texto].
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