Status:
UNKNOWN
Hyperbaric-oxygen Therapy (HBOT) Versus Placebo for Treating Vaso-Occlusive Crisis (VOC) in Sickle Cell Disease (SCD)
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
University Hospital, Toulouse
Hospices Civils de Lyon
Conditions:
Sickle Cell Disease
Hyperbaric Oxygen Therapy
Eligibility:
All Genders
8+ years
Phase:
PHASE3
Brief Summary
This is a randomised, controlled, double-blind, placebo trial of HBOT (intervention) superiority in the treatment of VOC in SCD, to demonstrate the effectiveness of HBOT for the decrease in pain level...
Detailed Description
Background: Sickle cell disease (SCD) is one of the most common genetic diseases in the world, affecting approximately 310,000 births each year and causing \>100,000 deaths. Vaso-occlusive crisis (VOC...
Eligibility Criteria
Inclusion
- Patients aged 8 or over;
- Diagnosed with a major SCD disorder (SS, SC, Hb O Arab, Sβ0 and Sβ+ -thalassemias);
- Presentation of a Vaso-Occlusive Crisis (VOC), with or without Acute Chest Syndrome,
- Unresponsive to level 2 analgesics (WHO classification)
- Which fulfils the criteria necessary for consultation at an ED;
- Ability to carry out the Valsalva manoeuvre;
- Ability to give informed consent and sign a written informed consent form (consent and signature of legal guardian authorised).
Exclusion
- Pregnancy;
- Indication for artificial ventilation (non-invasive ventilation/oro-tracheal intubation);
- Proven contraindication for HBOT established by a physician responsible for hyperbaric medicine;
- Anomaly in the results of prior transcranial Doppler (TCD) ultrasound (\> 200 cm/sec) or a previous history of stroke (but TCD will not be performed for the study);
- Patients requiring more than 2 l/min of normobaric oxygen in order to maintain an SpO2 ≥ 92%.
Key Trial Info
Start Date :
September 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05289700
Start Date
September 15 2022
End Date
March 31 2025
Last Update
November 2 2022
Active Locations (3)
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1
Hospices civils de Lyon
Lyon, France
2
Centre de compétences Sd drépanocytaires
Toulouse, France
3
HUG
Geneva, Switzerland, 1211