Conectar
Despite the known haemostatic action of emicizumab (Hemlibra) in haemophilia A patients, its role in the prevention and control of bleeding in high-demand haemostatic situations, such as major surgery, remains to be determined. Patients receiving regular emicizumab prophylaxis often require concomitant factor VIII (FVIII) therapy during major surgery to prevent uncontrolled bleeding and to promote postoperative healing. However, there are limited prospective surgical data relating to concomitant FVIII and emicizumab use. Simoctocog alfa (Nuwiq) is a B-domain deleted recombinant FVIII produced in a human cell line without chemical modification or protein fusion with proven efficacy as surgical prophylaxis in adult and paediatric patients. The Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis (NuPOWER) study aims to examine perioperative efficacy and safety of simoctocog alfa in haemophilia A patients on emicizumab prophylaxis undergoing major surgery.
NuPOWER is a prospective, open-label, single-arm, multicentre study that will be conducted at approximately 15 centres worldwide. Up to 28 male patients ≥12 years with severe haemophilia A and no FVIII inhibitors will be recruited. All patients must be receiving regular emicizumab prophylaxis and scheduled to undergo a major surgical procedure during which concomitant simoctocog alfa will be administered. The primary endpoint is the overall haemostatic efficacy of simoctocog alfa, adjudicated by an independent data monitoring committee using a pre-defined algorithm, and will consider intraoperative and postoperative efficacy assessments by the surgeon and investigator, respectively. Secondary endpoints include intraoperative haemostatic efficacy, postoperative haemostatic efficacy, number of allogeneic blood products transfused, perioperative FVIII plasma levels (as measured by FVIII activity) and thrombin generation, and safety parameters. In the era of non-factor therapy, NuPOWER will generate valuable prospective data on concomitant use of simoctocog alfa and emicizumab prophylaxis in patients with severe haemophilia A undergoing major surgery.
Ethical approval has been received from institutional review boards/independent ethics committees, and the study will be conducted in compliance with the Declaration of Helsinki. This work will be disseminated by publication of peer-reviewed manuscripts and presentations at scientific meetings.
CT EU 2022-502060-21-00; NCT05935358.
To combine, synthesise, and interpret qualitative evidence from studies exploring the causes, immediate responses, and preventive measures of needle stick injuries from the perspective of healthcare workers.
In this qualitative evidence synthesis, the qualitative data from the included studies were synthesised to identify overarching themes. The Preferred Reporting Items for Systematic Reviews and Meta-analysis flowchart, Joanna Briggs Institute tool, and Enhancing Transparency in Reporting the Synthesis of Qualitative Research checklist were used in the meta-synthesis process.
The MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Web of Science, ProQuest, ClinicalKey and Scopus databases were searched between December 14 and December 31, 2024 for studies published between January 2000 and December 2024.
Nine primary research studies were included and the following themes were identified: unpredicted patient movement, casual attitude, recapping, excessive workload, scarcity of article or safety equipment, inadequate training or experience, vigilance, ongoing training, nurturing workplace culture, emotional response, re-living the injury and fear of reprimand.
Needle stick injuries result from a complex interplay of individual, administrative, engineering, and environmental factors, but there are potential solutions to address these issues.
Policymakers in healthcare settings would benefit greatly from an understanding of the causes, immediate responses, and preventive aspects of needle stick injuries. These findings can direct the creation of focused interventions and safety procedures by identifying important risk variables and useful coping mechanisms.
The causes, immediate responses, and preventive measures of needle stick injuries were explored. Findings can help develop protocols to lower needle stick injury rates and increase worker safety.
ENTREQ guidelines.
This research is a systematic review of published peer-reviewed studies.
PROSPERO registration number: CRD42024620673.
FreshRSS 