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Adapted physical activity, exergaming and relaxation by biofeedback in haematological intensive care unit in France: study protocol of a randomised controlled trial (APAER-H trial)

Por: Bousmia · J. · Langlet · C. · Elnar · A. A. · Goetz · C. · Bolmont · B. · Dorvaux · V.
Introduction

Haematological malignancies and their treatments are known for their significant adverse effects on health-related quality of life (QoL). During high-dose cytotoxic therapy in haematological intensive care units (HICU), adapted physical activity (APA) is recognised for its role in maintaining physical fitness and limiting fatigue. Psychological and emotional states are also impaired, with anxiety levels significantly increasing in this specific context. Limited information is available about this topic. However, APA has been shown to reduce anxiety in various populations, including oncological patients. Furthermore, adding new technology, such as exergaming or heart rate variability biofeedback (HRVB) relaxation tools, could be an effective way to regulate emotions during treatments while providing the health benefits of APA. APA, Exergaming and Relaxation by Biofeedback in Haematological Intensive Care Unit protocol is a randomised, controlled trial. Our study is designed to evaluate the effects of APA programmes during high-dose cytotoxic therapy in HICU on anxiety, fatigue level, functional capacities, immune system activity and global QoL. Additionally, we aim to analyse the added value of using specific devices, such as Exergaming and HRVB relaxation, on the aforementioned parameters. We expect a difference in effectiveness between the programmes concerning emotional regulation.

Methods and analysis

90 patients (18–75 years), with various forms of haematological malignancies admitted to HICU, with haematologist’s approval for APA, who have given their written informed consent, will be randomly allocated in a 1:1:1 ratio to three 3-week APA groups: APA only (APA), APA by exergaming (EXER), APA+Biofeedback relaxation (BIO) (30:30:30). APA sessions will consist of moderate aerobic training on cyclo-ergometer (classical stationary bicycle for APA, BIO and connected ergometer in EXER), three times per week. The HRVB training will consist of controlled breathing exercises with biofeedback of heart rate variability at the end of each APA session (BIO). The primary outcome is to evaluate the effect of three short APA programmes on state anxiety (Hospital Anxiety and Depression Scale and State and Trait Anxiety Inventory-YA (STAI-YA)). The secondary outcomes will assess the effects on fatigue (Multidimensional Fatigue Inventory–20), physical fitness (2-minute walk test; five-times sit to stand test), QoL (European Organisation for Research and Treatment of Cancer - Quality of Life Questionnary ; EORTC-QLQ-C30) and immune system functioning (blood samples). All of these assessments are evaluated initially (T0) and directly after intervention (T2).

Ethics and dissemination

Approval was obtained from the French South Mediterranean III ethical committee. Subjects are recruited after providing written consent after receiving the information provided by the investigator. According to French law and the French Data Protection Authority (Commission Nationale de l’Informatique et des Libertés ; CNIL), we are not authorised to publicly share individual participant data. The results of the Adapted Physical Activity, Exergaming and Relaxation by Biofeedback in Haematological Intensive Care Unit study will be disseminated through publication in peer-reviewed journals, presentations at scientific conferences and communication with stakeholders and participants.

Trial registration number

French Sud Mediteranian III ethical committee and registered on ClinicalTrials.gov: NCT05475600.

Duffy-null variant and practical implications for patient care: a scoping review

Por: Asiimwe · E. · Ngo · T. P. · Ziv · E. · Leavitt · A. D.
Objective

To evaluate and map research examining clinical associations with the Duffy-null variant.

Design

Scoping review of the existing literature.

Data sources

We conducted a systematic search of PubMed, Embase, CINAHL and Web of Science for studies published in English between 1 January 2000 and 25 June 2024.

Eligibility

Studies were eligible for inclusion if they examined associations relevant to current standard clinical practice and met our protocol’s inclusion criteria.

Data extraction

We extracted the following information from included studies: study year(s), patient population, sample size, study design, primary outcome and primary findings. Studies were grouped by outcome and synthesised in tabular and qualitative formats.

Results

A total of 2737 studies were screened, and 44 met our inclusion criteria. Most studies were observational, and the most common research question examined was the association with resistance to Plasmodium vivax malaria (9/44). Overall, we observed that the association between the Duffy-null variant and asymptomatic lower absolute neutrophil count (ANC) is demonstrated in large prospective cohort studies. The association with resistance to P. vivax malaria is primarily supported by large cross-sectional studies. There were no studies examining the practical applications of these findings, for example, optimal Duffy-genotype adjusted ANC thresholds for clinical decision-making in patients receiving chemotherapy. Finally, we observed that 19 different associations with this trait have been explored, several in conditions with no clear link to the Duffy trait, for example, progression rates in HIV/AIDS, risk of diabetes, etc.

Conclusions

We found established associations between the Duffy-null variant and asymptomatic lower ANC and with resistance to P. vivax malaria but a lack of data for the practical utilisation of these findings in clinical care. Future studies, such as those examining safe ANC values for entry into clinical trials and for ANC nadir for Duffy-null patients receiving medications associated with increased risk of neutropenia, for example, clozapine, are needed. We observed numerous reported associations of unclear clinical utility. Studies investigating associations with the Duffy trait should be guided by biologic plausibility and clinical utility of positive findings.

NuPOWER (Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis): protocol for an open-label, single-arm, multicentre study

Por: Srivastava · A. · Kanny · A. · Langer · F. · Kubicek-Hofmann · C. · Alvarez Roman · M. T. · Nunez Vazquez · R. · Boban · A. · Dejanova-Ilijevska · V. · Miljic · P. · Garcia · J. · Halimeh · S. · Drillaud · N. · Valentin · J.-B. · Mancuso · M. E. · Castaman · G. · Santoro · R. C. · Leht
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

CT EU 2022-502060-21-00; NCT05935358.

Consent for transfusion: global practices, documentation and patient understanding - a scoping review protocol

Por: Pereira · V. C. · Bezerra Salviano · F. W. · Brunetta · D. M. · Cipolotti · R.
Introduction

Patient involvement in healthcare has become increasingly important, not only as an expression of respect for autonomy but also as a means of empowering individuals to safeguard their care. In blood transfusion, informed consent is a critical tool for shared decision-making. This protocol outlines a scoping review to map how transfusion consent processes and forms are used globally and to characterise their key features. We aim to identify technologies used to obtain consent, evaluate compliance with international recommendations, describe practices in special populations and examine patients’ and families’ understanding of the consent process.

Methods and analysis

Following the Joanna Briggs Institute methodology, we will search PubMed, Embase, LILACS, Web of Science and Scopus; grey literature will be explored via Google Scholar and the Open Access Theses and Dissertations platform. No language or date restrictions will be applied. Reference lists of included studies will also be screened. Two reviewers will independently screen studies and chart data; disagreements will be resolved by a third reviewer. Synthesis will be diagrammatic/tabular with structured narrative, reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses: extension for Scoping Reviews. Where data allow, findings will be stratified by clinical setting. A stakeholder consultation with two transfusion medicine experts and two patient representatives will be undertaken to validate and refine interpretations.

Ethics and dissemination

Only publicly available sources will be used; research ethics approval is not required. Findings will be submitted to a peer-reviewed journal and presented at scientific meetings.

Trial registration number

10.17605/OSF.IO/NU69J.

Association between ABO blood group and blood component transfusion requirements in dengue infection: a retrospective study from a tertiary hospital in Kerala, India

Por: Cherupanakkal · C. · Jacob · A. · Olickal · J. J. · Varughese · J. E. · Thampi · A. · Jacob · A. A. · Mathew · R. · Jayaprasad · G. · Varghese · J. E.
Objective

Platelet and fresh frozen plasma (FFP) transfusions are routinely employed in the management of severe dengue. Previous research has indicated a potential link between ABO blood groups and susceptibility to dengue, with evidence suggesting that mosquito vector feeding preferences may be influenced by host blood type. These factors could potentially impact transfusion demands during outbreaks. This retrospective study aimed to investigate the relationship between ABO blood groups and transfusion requirements in patients with dengue.

Design

Retrospective study.

Setting

The study was conducted at a tertiary care hospital in Kerala.

Methods

Clinical and laboratory data were reviewed for 199 patients confirmed with dengue who received blood component transfusions and compared with two control groups: 200 randomly selected patients with dengue who did not require transfusions and 200 patients without dengue who required transfusions, over a period spanning January 2015 to March 2023.

Results

Among transfused dengue cases, blood groups O (41.71%), A (28.14%) and B (23.12%) were most prevalent; however, no statistically significant association was observed between ABO blood group and transfusion requirement. Furthermore, the total volumes of FFP and platelet transfusions did not differ significantly across ABO groups among patients with dengue. Notably, platelet transfusions were significantly more frequent in dengue cases (92.0%) compared with transfused patients without dengue (35.5%), whereas FFP transfusions were more common in non-dengue transfused cases (84.5%) than in patients with dengue (44.7%). Patients with dengue also received significantly higher mean volumes of both FFP and platelets.

Conclusion

Despite earlier reports linking ABO blood types to dengue susceptibility, this study found no significant association with transfusion requirements, warranting confirmation through larger multicentre studies.

High flow oxygen for vaso-occlusive crisis: a multicentre, prospective, randomised, multi-arm, multi-stage clinical trial (OSONE)

Por: Mekontso Dessap · A. · Habibi · A. · Guillaud · C. · Kassasseya · C. · Larrat · C. · Agbakou · M. · Tchoubou · T. · Candille · C. · Carpentier · B. · Landais · M. · Arlet · J.-B. · Fartoukh · M. · Desclaux · A. · Masseau · A. · Oziel · J. · Bouharaoua · S. · Affo · C. · Viglino · D. · Bouk
Introduction

Sickle cell disease (SCD) is due to the mutation of haemoglobin (Hb), from HbA to HbS and characterised by recurrent vaso-occlusive crises (VOC), which can progress to acute chest syndrome (ACS), a leading cause of death in adults with SCD. Hypoxia is a key modifiable factor in the polymerisation of HbS and the pathogenesis of VOC. High-flow nasal oxygen (HFNO) delivers humidified gas at high oxygen concentrations and flow rates: the former may reverse sickling (metabolic effect) to accelerate VOC resolution and prevent ACS, while the latter may reduce the risk of ACS by mitigating hypercapnia and generating positive airway pressure that limits hypoventilation and atelectasis (pulmonary effect). The study hypothesises that HFNO is a safe and effective strategy for treating VOC and preventing secondary ACS, and will assess this using a multi-arm multi-stage (MAMS) trial design.

Methods and analysis

This is a prospective, multicentre, randomised, open-label controlled trial following an MAMS design with three phases and four arms: one control (low-flow oxygen) and three HFNO intervention arms with varying fraction of inspired oxygen levels (low, intermediate, high). The pilot stage will assess safety and feasibility, using the rate of cardiac and neurological events as the primary endpoint. In the activity stage, arms demonstrating acceptable safety will be compared for efficacy based on the rate of VOC resolution without complications by day 5, allowing selection of the most promising arm. The final efficacy stage will compare the selected HFNO strategy to control, with prevention of secondary ACS by day 14 as the primary endpoint. The study aims to enrol up to 350 VOC episodes in total.

Ethics and dissemination

The study has been granted ethical approval (CPP SUD MEDITERRANEE IV). Following the provision of informed consent, patients will be included in the study. The results will be submitted for publication in peer-reviewed journals.

Trial registration number

NCT03976180.

Flow cytometric lyophilised reagent tube assay for peripheral blood neutrophil myeloperoxidase expression to rule out myelodysplastic neoplasms at a university hospital: a diagnostic accuracy study

Por: Planta · C. · Scheffen · L. · Jacob · M.-C. · Szymanski · G. · Chevalier · S. · Tondeur · S. · Bulabois · B. · Meunier · M. · Lefebvre · C. · Gonnet · N. · Garban · F. · Molina · L. · Paradis · C. · Seigneurin · A. · Chiriac · R. · Merle · R. · Labarere · J. · Park · S. · Raskovalova · T.
Objectives

Although flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression can accurately rule out myelodysplastic neoplasms (MDS), it lacks reliability and efficiency due to the practical limitations of laboratory-developed liquid reagent-based assays. This study aimed to quantify the agreement and comparative discriminatory accuracy between a single-use flow cytometric lyophilised reagent tube (BD Lyotube Stain 468) and its laboratory-developed liquid reagent counterpart.

Design

Cross-sectional diagnostic accuracy study of two index tests against a reference diagnosis.

Setting

A university hospital in France.

Participants

Consecutive adult patients with an indication for bone marrow aspiration due to suspected MDS and unexplained peripheral blood cytopenia.

Primary outcome

MDS confirmed by cytomorphological evaluation of the bone marrow aspirate performed in duplicate by experienced haematopathologists blinded to the index test.

Results

Of 103 participants enrolled between July 2020 and August 2021, 37 had MDS (prevalence, 36%). The median intra-individual robust coefficient of variation (RCV) for myeloperoxidase expression was 30.9% using the BD Lyotube Stain 468 and 31.2% using the laboratory-developed liquid reagent assay, with an intraclass correlation coefficient of 0.94 (95% CI 0.91 to 0.96). The areas under the receiver operating characteristic curves were 0.83 (95% CI 0.74 to 0.90) and 0.82 (95% CI 0.73 to 0.89), respectively. Using a prespecified threshold of 30.0%, the corresponding sensitivity estimates were 89% (95% CI 75% to 97%) and 95% (95% CI 82% to 99%).

Conclusion

BD Lyotube Stain 468 performs as well as its laboratory-developed liquid reagent counterpart for the quantification of myeloperoxidase expression by peripheral blood neutrophils. It may obviate the need for invasive bone marrow aspiration in up to 40% of patients with suspected MDS.

Trials registration number

NCT04399018.

Predictive machine-learning model for screening iron deficiency without anaemia: a retrospective cohort study

Por: Efros · O. · Soffer · S. · Mudrik · A. · Robinson · R. · Kenet · G. · Nadkarni · G. N. · Klang · E.
Objectives

This study aimed to develop and validate a machine-learning (ML) model to predict iron deficiency without anaemia (IDWA) using routinely collected electronic health record (EHR) data. The primary hypothesis was that an ML model could achieve better accuracy in identifying low ferritin levels (

Design

A retrospective cohort study.

Setting

Data were derived from secondary and tertiary care facilities within the eight-hospital Mount Sinai Health System, an urban academic health system.

Participants

The study included 211 486 adult patients (aged ≥18 years) with normal haemoglobin levels (≥130 g/L for men and ≥120 g/L for women) and recorded ferritin measurements.

Primary and secondary outcome measures

The primary outcome was the prediction of low ferritin levels (

Data from 211 486 Mount Sinai Health System patients with normal haemoglobin levels and ferritin testing were analysed. The model used demographic data, blood count indices and chemistry results to identify low ferritin levels (

Results

Of the 211 486 patients analysed, 19.56% (n=41 368) of the patients had low ferritin levels. In the low ferritin group, the mean age was 41.28 years with 89.64% females. In contrast, the normal ferritin group had a mean age of 50.14 years with 62.02% females. The model achieved an area under the curve (AUC) of 0.814. At a sensitivity threshold of 70%, the model had a specificity of 75.85%, with a positive predictive value of 37.6% and a negative predictive value of 92.41%. The model outperformed an alternative model based only on complete blood count indices (AUC 0.814 vs 0.741). Subgroup analysis showed that model accuracy varied by sex and age, with lower performance in premenopausal women (AUC 0.736) compared with postmenopausal women (AUC 0.793) and men (AUC of 0.832 in those under 60 years and 0.806 in those aged 60 and above).

Conclusions

The ML model provides an effective approach to screening for IDWA using readily available EHR data. Implementing this tool in clinical settings may facilitate early diagnosis of IDWA.

Indications for hospitalisation and predictors of 30-day re-admission of patients with sickle cell disease in Uganda: a retrospective study

Por: Kibone · W. · Muzoora · C. · Bongomin · F. · Namiiro · M. A. · Ssenkungu · S. · Ochola · E. · Kasirye · P. · Hamer · D. H.
Background

Sickle cell disease (SCD) is associated with significant mortality and morbidity, especially in low- and middle-income countries.

Objectives

We determined the indications for hospitalisation and predictors of 30-day re-admission among patients with SCD in Northern and Central Uganda.

Design

Retrospective chart review.

Setting

Mulago National Referral Hospital in Kampala, St. Mary’s Hospital Lacor in Gulu and Gulu Regional Referral Hospital in Gulu, Uganda.

Participants

Patients with confirmed SCD admitted between January 2020 and January 2025 were included.

Outcomes

Primary outcome: indication for hospitalisation. Secondary outcomes: rate and predictors of 30-day hospital re-admission. Socio-demographic, clinical history and hospitalisation data were extracted using a pretested data extraction tool.

Results

We enrolled 505 patients, accounting for 714 hospital admissions, with a mean age of 8.1±6.2 years. Most participants (n=489, 96.8%) had less than four admissions per year, with a median of 1 admission (IQR: 0–2). The most common indications for hospitalisation were infection (n=375, 52.5%), painful crisis (n=366, 51.3%) and anaemia (n=186, 26.1%). Malaria was the most prevalent infection (n=244, 65%). The median length of hospital stay was 4 days (IQR: 3–6), with a 30-day re-admission rate of 6.9% (n=49). Admission with painful crisis (adjusted OR (AOR): 0.45, 95% CI: 0.23 to 0.89, p=0.021), receiving a blood product (AOR: 0.32, 95% CI: 0.16 to 0.66, p=0.002) and having four or more admissions per year (AOR: 0.84, 95% CI: 0.04 to 0.17, p

Conclusions

Infections, especially malaria, and painful crises were the leading causes of hospitalisation among Ugandan patients with SCD. Frequent admissions, painful crises and blood transfusions were associated with lower 30-day re-admission risk. There is an urgent need to strengthen malaria prevention strategies and optimise access to disease-modifying therapy, such as hydroxyurea, to improve patient outcomes.

Centrifugation versus filtration-based cell salvage: impact on perioperative bleeding in cardiac surgery--the COLTRANE randomised clinical trial - study protocol

Por: Beurton · A. · Mansour · A. · Benard · A. · Pernot · M. · Brett · V.-e. · Batsale · C. · Aitgougam · A. · Cordon · A. · Mouton · C. · Fresselinat · A. · Robert · G. · Imbault · J. · Nesseler · N. · Ouattara · A.
Introduction

Cardiac surgery remains a high-risk procedure for bleeding despite advances in patient blood management. Conventional centrifugation-based autotransfusion devices primarily recover red blood cells, losing platelets and coagulation factors. The SAME autotransfusion device (i-SEP, Nantes, France) introduces an innovative filtration-based approach, recovering erythrocytes, leucocytes and platelets to enhance perioperative haemostasis. The main objective is to determine whether the filtration-based SAME device reduces significant perioperative bleeding compared with the centrifugation-based system in high-risk cardiac surgery patients.

Methods and analysis

The Centrifugation-based vs filtration-based intraOperative cell saLvage on qualiTy of peRioperAtive haemostasis iN cardiac surgEry (COLTRANE) trial is a multicentre, parallel-group, single-blinded, superiority-randomised clinical trial. Conducted over 19 months in 10 French hospitals, the study will target patients at high risk of bleeding undergoing on-pump cardiac surgery via sternotomy. A total of 570 patients (285 per group) are required to achieve 80% statistical power for detecting clinically significant differences. Eligible patients will be randomised to either a centrifugation-based or filtration-based autotransfusion group. Both groups will follow standardised perioperative and cardiopulmonary bypass management, with the devices used only intraoperatively. The primary outcome is the proportion of patients with clinically significant perioperative bleeding defined as classes 2 to 4 of the Universal Definition of Perioperative Bleeding. The secondary outcomes include device efficiency and safety, perioperative haemostasis, lengths of intensive care unit and hospital stays, early postoperative morbidity and 30-day all-cause mortality. Ancillary studies will be performed to evaluate cell recovery and washing performance, the viscoelastic properties of retransfused blood (Quantra Qplus; Stago, Asnières-sur-Seine, France), and the effect of salvaged leucocytes on postoperative inflammation and immune function.

Ethics and dissemination

This trial has received a favourable opinion from the Committee for the Protection of Persons and authorisation from the French authorities (Comité de protection des personnes Nord Ouest, IDRCB: 2023-A02566-39). Protocol V.1.1 was approved on 22 January 2024. The trial is registered on ClinicalTrials.gov (NCT06425614). The findings will be disseminated through oral communications at national and international scientific meetings and peer-reviewed journal publications. Individual participant data will be made available on reasonable request to qualified researchers, following review and approval by the study sponsor and ethics committee.

Trial registration number

ClinicalTrials.gov, NCT06425614.

Attitudes and practices toward anxiety among haemodialysis patients: a multicentre cross-sectional study in Qingdao, China

Por: Zhou · B. · Jiang · W. · Li · H. · Li · L. · Yuan · G. · Liu · Y. · Lai · X. · Cui · L. · Xu · Y.
Objectives

To investigate anxiety levels, as well as attitudes and practices toward anxiety in patients undergoing haemodialysis.

Design

Cross-sectional study conducted from May to August 2023.

Setting

This study was conducted from May to August 2023 at multiple haemodialysis units in Qingdao, China.

Participants

Adult patients who regularly undergo haemodialysis were invited to participate.

Interventions

NA.

Primary and secondary outcome measures

The participants’ anxiety, attitudes and practices related to their condition were measured by a self-designed questionnaire. The demographic characteristics were also collected as exposure variables.

Results

A total of 535 patients participated, with a mean age of 55.50±14.30 years; 314 were male. The average duration of haemodialysis was 4.69±3.80 years. The patients had a mean anxiety score of 59.71±7.59. Attitude and practice scores averaged 17.66±4.88 (range: 6–30) and 32.12±6.28 (range: 8–40), respectively. Multivariate linear regression showed that a monthly household income of ¥5001–10 000 (β=1.2, p=0.006) and anxiety score (β=0.215, p

Conclusions

Patients undergoing haemodialysis exhibited high anxiety levels alongside proactive practices and negative attitudes. Anxiety was positively associated with attitudes but negatively with practices, indicating that proactive practices may alleviate anxiety. Targeted mental health strategies are needed to enhance the quality of life for haemodialysis patients.

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