Protocol Overview
Study Title: Hyperbaric Oxygen Therapy (HBOT) for Treating Vaso-Occlusive Crisis (VOC) in Sickle Cell Disease (SCD)
Publication: BMJ Open, November 2024
Introduction
Sickle cell disease (SCD) is a common genetic disorder that affects many newborns and leads to serious complications, including vaso-occlusive crisis (VOC). VOC can cause severe pain and significantly reduce life expectancy. Hyperbaric oxygen therapy (HBOT) may help by increasing oxygen delivery to tissues, potentially reducing pain from VOC. Previous studies suggest HBOT is safe and may benefit patients with VOC.
Study Goals
- Evaluate the safety and effectiveness of HBOT for treating VOC.
- Understand how HBOT works biologically.
- Assess the cost-effectiveness of HBOT.
Methods
This study is a multicentric, triple-blinded, randomized controlled trial involving patients aged 8 and older with diagnosed major forms of SCD experiencing VOC. Key points include:
- Patients will receive standard care for VOC, including pain relief and hydration.
- Eligible patients will be randomly assigned to either the HBOT group or a sham treatment group.
- HBOT will involve a session of 90 minutes at a higher pressure to increase oxygen levels.
- Patients will be monitored for pain relief and other outcomes over 6 hours and during subsequent treatment sessions.
Outcomes
The primary outcomes to measure include:
- Change in pain levels measured by a Visual Analogue Scale (VAS).
- The number of patients needing high levels of pain medication after treatment.
Additional outcomes will assess morphine usage, hospital stay duration, patient satisfaction, and any complications.
Ethics and Communication
This study has received ethical approval, and results will be shared through medical journals and conferences.
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