Protocol for a multicentric, double-blind, randomised controlled trial of hyperbaric oxygen therapy (HBOT) versus sham for treating vaso-occlusive crisis (VOC) in sickle cell disease (SCD) in patients aged 8 years or older (HBOT-SCD study)

Article Article scientifique Article Protocol for a multicentric, double-blind, randomised controlled trial of hyperbaric oxygen therapy (HBOT) versus sham for treating vaso-occlusive crisis (VOC) in sickle cell disease (SCD) in patients aged 8 years or older (HBOT-SCD study) eng 2024-11-28 2024-11 author Stirnemann Jérôme 0000-0001-9964-4452 Department of Medicine, Geneva University Hospitals, Geneva, Switzerland Jerome.stirnemann@hcuge.ch. 793435 Département de médecine (DEMED) author Serratrice Jacques Department of Medicine, Geneva University Hospitals, Geneva, Switzerland. 836481 Département de médecine (DEMED) author Mann Tamara Department of Medicine, Geneva University Hospitals, Geneva, Switzerland. author Louge Pierre Subaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland. 990492 author Combescure Christophe 0000-0003-2631-4780 Diagnostic of Health and Community Medicine, Geneva University Hospitals, Geneva, Switzerland. 670542 Département de santé et médecine communautaire (MECOM) author Samii Kaveh Division of Haematology, Geneva University Hospitals, Geneva, Switzerland. 24652 author Pignel Rodrigue Subaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland. 818281 author Agoritsas Thomas 0000-0002-6182-9969 Department of Medicine, Geneva University Hospitals, Geneva, Switzerland. 516829 Département de médecine (DEMED) author Ansari Djaberi Marc Georges CANSEARCH Research Platform in Paediatric Oncology and Haematology of the University of Geneva, University of Geneva, Geneva, Switzerland.,Division of Paediatric Oncology and Haematology, University Hospitals of Geneva Department of Women-Children-Teenagers, Geneva, Switzerland. 61572 Département de Pédiatrie, Gynécologie et Obstétrique (PETRI) author Cannas Giovanna Sickle-Cell Disease Reference Center, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France. author Chalandon Yves 0000-0001-9341-8104 Hematology Department, Geneva University Hospitals, Geneva, Switzerland. 644957 Département de médecine (DEMED) author Cimasoni Laurent Uberto Division of Paediatric Oncology and Haematology, Geneva University Hospitals, Geneva, Switzerland. 134791 author Cougoul Pierre Sickle-cell Reference Center, Institut Universitaire du Cancer de Toulouse Oncopole CHU Toulouse, Toulouse, Occitanie, France. author Desgraz Benoît Subaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland. 978102 author Gervaix Alain Department of Women-Children-Teenagers, Geneva University Hospitalse, Geneva, Switzerland. 31715 Département de Pédiatrie, Gynécologie et Obstétrique (PETRI) author Grosgurin Olivier Department of Medicine, Geneva University Hospitals, Geneva, Switzerland. 503200 Département de médecine (DEMED) author Joffre Thierry Hyperbaric Center, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France. author Lae Claude Subaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland. 838650 author Magnan-Rondot Marie-Anne Subaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland. 838651 author Menager Etienne Subaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland. author Momo Bona Annie Emergency Department, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, Occitanie, France. author Panchard Marc-Alain Subaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland. 944731 author Pellegrini Michel Subaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland. 838652 author Reny Jean-Luc 0000-0002-7528-7363 Department of Medicine, Geneva University Hospitals, Geneva, Switzerland. 704339 Département de médecine (DEMED) author Riu Beatrice Hyperbaric Center, Institut Universitaire du Cancer de Toulouse Oncopole CHU Toulouse, Toulouse, Occitanie, France. author Sahyoun Cyril Department of Women-Children-Teenagers, Geneva University Hospitals Children's Hospital, Geneva, Switzerland. 892237 author Boet Sylvain 0000-0002-1679-818X Subaquatic and Hyperbaric Medicine Unit, Emergency Service, Acute Medicine Department, Geneva University Hospitals, Geneva, Switzerland. 413164 Département d'anesthésiologie, pharmacologie et soins intensifs (APSIC) e084825 10.1136/bmjopen-2024-084825 39613437 2044-6055 PMC11605825 https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2024-084825 Introduction: Sickle cell disease (SCD) is one of the most common genetic diseases in the world, annually affecting approximately 310 000 births and causing >100 000 deaths. Vaso-occlusive crisis (VOC) is the most frequent complication of SCD, leading to bone pain, thoracic pain (acute chest syndrome) and/or abdominal spasms. It is the main cause of mortality in patients with SCD, reducing life expectancy. Hyperbaric oxygen therapy (HBOT) is a safe and well-established method of increasing tissue oxygen delivery immediately by up to 10-fold to 20-fold. In the context of VOC, HBOT has the potential to limit sickling. A previous pilot study of nine patients showed the safety and potential benefits of HBOT on VOC-induced pain. Our study aimed to assess the clinical safety and effectiveness of HBOT for treating VOC, its biological mechanisms of actions and its cost-effectiveness. Methods and analysis: This is a multicentric, triple-blinded, randomised controlled trial. Patients aged 8 years or above with a diagnosed major form of SCD, presenting at one of the participating centres' emergency departments (EDs) with a VOC requiring level 3 analgesia (according to WHO definition), will be eligible. Exclusion criteria are pregnancy, mechanical ventilation, previous history of stroke or prior transcranial Doppler ultrasound anomaly, contraindication to HBOT and the need for above 2 L/min of oxygen. All patients will receive the usual care for VOCs, including hydration, analgesics, normobaric oxygen therapy and when medically indicated, antibiotic therapy and/or transfusions. Within 24 hours of their arrival in the ED (or longer in specific cases), and after obtaining informed consent, patients will be randomised into the HBOT intervention group (2.0 atmosphere absolute (ATA), 90 min, FIO2 =1) or the sham group (1.3 ATA, 90 min, FIO2 =0.21). After their first HBOT session, patients will return to their acute-care ward. Patients in both arms will undergo a second and third session within 24-36 hours of the first, unless their Visual Analogue Scale (VAS)-pain is ≤2 without use of level 3 analgesics. The difference in the pain-VAS before and after HBOT and other outcomes will be compared between the intervention and sham groups. Our composite primary outcome will be (1) the change in global VAS-pain 6 hours after initiation of HBOT; (2) the number of patients with a VAS-pain score >4 and/or a morphine dosage >1 mg/hour intravenous after the HBOT/sham session. Other outcomes to be reported are morphine usage, length of stay, biological parameters, satisfaction, complications and cost. Ethics and dissemination: Ethical approval CER Geneva 2019-01707 (last submission V.5.1, 06.15.2023). The results of the studies will be disseminated by several media, including publications in peer-reviewed international medical journals, and presentations at national and/or international conferences. Trial registration number: <a href="http://clinicaltrials.gov/show/NCT04978116" rel="noopener noreferrer" target="_blank">NCT04978116</a>. Adolescent Adult Anemia, Sickle Cell / complications Anemia, Sickle Cell / therapy Child Double-Blind Method Female Humans Hyperbaric Oxygenation / methods Male Multicenter Studies as Topic Randomized Controlled Trials as Topic Young Adult Clinical Trial Protocol Dewey 613 Dewey 616 Dewey 617 Dewey 618 French Society of Physiology and Subaquatic and Hyperbaric Medicine 63 Département d'anesthésiologie, pharmacologie, soins intensifs et urgences 229 217 Centre de recherche clinique 201 56 Département de médecine 221 64 Département de santé et médecine communautaires 22A 58 Département de pédiatrie, gynécologie et obstétrique 223 false 319 Groupe Perrier Arnaud (Médecine interne générale, de réhabilitation et de gériatrie) 585 88 Epidémiologie clinique et biostatistique 115 1216 Leucémie et transplantation allogénique de cellules souches hématopoïétiques 982 11 Plaquettes et antithrombotiques 13 564 Oncologie et hématologie pédiatriques 907 https://clinicaltrials.gov/study/NCT04978116 BMJ open 14 11 2e6ff53c-b198-4fa3-9b2a-645a96d5ff2e Article (Published version) Public bmjopen-14-11.pdf 866314 application/pdf CC BY-NC-4.0 91f880c49d44c3705232e67d72e0494a5ca136adeabf2c4d36bc14361f973d66 Vignette Public bmjopen-2024-November-14-11--F1.large.jpg 186253 image/png openAccess Faculté de médecine / Section de médecine clinique / Département d'anesthésiologie, pharmacologie, soins intensifs et urgences Faculté de médecine / Centre de recherche clinique Faculté de médecine / Section de médecine clinique / Département de médecine Faculté de médecine / Section de médecine clinique / Département de santé et médecine communautaires Faculté de médecine / Section de médecine clinique / Département de pédiatrie, gynécologie et obstétrique

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Protocol for a multicentric, double-blind, randomised controlled trial of hyperbaric oxygen therapy (HBOT) versus sham for treating vaso-occlusive crisis (VOC) in sickle cell disease (SCD) in patients aged 8 years or older (HBOT-SCD study)	BMJ open	2024	114	282
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Magnan-Rondot, Marie-Anne