Protocol for a multicentric, double-blind, randomised controlled trial of HBOT versus sham for vaso-occlusive crisis in sickle cell disease (HBOT-SCD study)

What Researchers Did

Researchers designed a multicentric, triple-blinded, randomized controlled trial to assess the safety, effectiveness, biological mechanisms, and cost-effectiveness of hyperbaric oxygen therapy (HBOT) for vaso-occlusive crisis (VOC) in sickle cell disease (SCD).

What They Found

This document describes the protocol for a randomized controlled trial, so no clinical findings or numerical results are available yet. The study aims to enroll patients aged 8 years or above with major SCD presenting with VOC requiring level 3 analgesia.

Canadian Relevance

This study protocol does not have a direct Canadian connection as it is not being conducted in Canada.

Study Limitations

The study's exclusion criteria, such as pregnancy, mechanical ventilation, and prior stroke, may limit the generalizability of its future findings to all patients with vaso-occlusive crisis.