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High-flow Oxygen for Vaso-occlusive Pain Crisis

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

Sickle cell disease (SCD) is characterized by recurrent vaso-occlusive pain crisis (VOC), which may evolve to acute chest syndrome (ACS), the most common cause of death among adult patients with SCD. Currently, there is no safe and effective treatment to abort VOC or prevent secondary ACS. Management of VOC mostly involve a symptomatic approach including hydration, analgesics, transfusion, and incentive spirometry, which was investigated in a very limited number of patients (\<30). The polymerisation of HbS is one major feature in the pathogenesis of vaso-occlusion. Among factors determining the rate and extent of HbS polymer formation, the hypoxic stimulus is one of the most potent and readily alterable. Current guidelines recommend oxygen therapy in patients with VOC in order to maintain a target oxygen saturation of 95%. Low-flow nasal oxygen (LFNO) is routinely used to achieve this

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years; * Patient with major sickle cell disease syndrome (SS, SC, Sβ0 or Sβ+); * VOC as defined by acute pain or tenderness, affecting at least one part of the body, including limbs, ribs, sternum, head (skull), spine, and/or pelvis, that requires opioids and is not attributable to other causes; * Intermediate-to-high risk for secondary ACS derived from the PRESEV score (Bartolucci et al, EBioMedicine 2016) as follows: a reticulocyte count \>216 G/L OR at least two of the followings : i) spine and/or pelvis CPS \>1; ii) leucocyte count \>11G/L; iii) hemoglobin ≤ 9 g/dL; in case of long-term treatment by hydroxyurea, only one of the above mentioned criteria will be needed, given its effects on hemoglobin, leucocyte and reticulocytes counts; * Informed consent; * Patient affiliated to social security Exclusion Criteria: The presence at inclusion of a primary ACS. Primary ACS is defined by the combination at time of randomization of a clinical sign \[chest pain or auscultatory abnormality (crepitants and/or bronchial breathing)\] with a new pulmonary infiltrate (on chest film, thoracic scan, or lung ultrasound); * VOC with need of parenteral opioids lasting longer than 72 hours at time of inclusion; * Known pregnancy or current lactation; Women of child bearing potential will be tested for pregnancy before inclusion; * Known cerebral vasculopathy or past medical history of stroke, due to Moya Moya or persisting visible macrovessel stenosis/occlusion; * Known ischemic heart disease or typical chest angina; * Patient who is currently enrolled in other investigational drug study; * Known legal incapacity, * Prisoners or subjects who are involuntarily incarcerated * Anatomical factors precluding placement of a nasal cannula
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What it tests

  • Stadard low-flow oxygen
  • HFNO with low FiO2 (21%-30%)
  • HFNO with intermediate FiO2 (50%)
  • HFNO with high FiO2 (100%)
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Where

1 site
Henri Mondor
Créteil, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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