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 in the treatment of SCD-VOC.
| Jérôme Stirnemann, Dr | |
| + 41 22 372 92 02 | |
| [email protected] |
| Jacques Serratrice, Dr | |
| [email protected] |
> 8 Years
Phase 3
Interventional
All
Device
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).
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%.