Periodic Reporting for period 4 - PROOF (Penumbral Rescue by Normobaric O=O Administration in Patients With Ischaemic Stroke and Target Mismatch ProFile: A Phase II Proof-of-Concept Trial)
Okres sprawozdawczy: 2021-07-01 do 2022-12-31
Within PROOF twelve clinical centres in eight European countries will test whether the consequences of stroke can be reduced by rapidly applying high-dose oxygen therapy.
The high-dose oxygen therapy is very simple and low-cost. The patient, after having been diagnosed with an ischemic stroke after their scan, wears a mask through which they inhale almost pure oxygen at a flow of 40 litres per minute. This keeps the oxygen content in the blood as high as it can be.
The aim is to ensure that the surrounding brain tissue at risk, which will have less oxygen but is not yet dead, is stabilized by the high oxygen content coming in. This continues until the clot is removed and the blood circulation is improved again. The treatment therefore aims at the so-called “shadow zones” of the stroke, sometimes called the “rescue zones”. These may include the entire stroke area in some patients.
PROOF is the first trial to thoroughly investigate high-dose oxygenation in stroke patients. If it proves that the brain can be saved by this, it could also bring great benefits to patients who are not near a clinic where stroke can be treated and who have longer access times to emergency care.
Main results achieved in period 4:
- Increasing numbers of patient enrolment to a sufficient level
- All regulatory and ethical approvals obtained
- Further revision of the eCRF
- Revision of worksheets to simplify the enrolment of patients for the study sites and to improve the process of data generation
- Update of all training materials
- Regular Newsletter
- Online-Consortium-Meetings and Board-Meetings
- Conducting Interim Analyses
• Improvement of health and quality of life for stroke patients,
• Scientific impacts for the researchers and clinicians working in the field - the PROOF trial results will be published in a peer reviewed journal with high impact (e.g. Neurology or higher)
• Healthcare impact for clinicians and rehabilitation professionals treating stroke patients – NBHO treatment will generate better treatment and rehabilitation outcomes, and
• Socio-economic impact on the health care system – improved patient outcomes will reduce healthcare costs and will also benefit society through early return of people with stroke to work
After termination of the study due to futility we need to wait for the results of the final analyses to check whether there are impacts still valid respectively how we need to change them in any way.