Trials / Terminated
TerminatedNCT03500939
Penumbral Rescue by Normobaric O2 Administration in Patients With Ischemic Stroke and Target Mismatch ProFile
Penumbral Rescue by Normobaric O=O Administration in Patients With Ischemic Stroke and Target Mismatch ProFile: A Phase II Proof-of-Concept Trial
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 223 (actual)
- Sponsor
- University Hospital Tuebingen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of the PROOF trial is to investigate efficacy and safety of normobaric hyperoxygenation (NBHO) as a neuroprotective treatment in patients with acute ischemic stroke due to large vessel occlusion likely to receive endovascular mechanical thrombectomy (TBY) in a randomized controlled clinical phase IIb trial.
Detailed description
http://www.proof-trial.eu/ European Union's Horizon 2020 research and innovation programme grant 733379 (2016): Euro 5.8 Mio
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Medical oxygen | inhalation of 100% oxygen at high flow via a sealed non-rebreather face-mask with reservoir |
| OTHER | Standard of care | e.g. thrombectomy, thrombolysis |
Timeline
- Start date
- 2019-08-01
- Primary completion
- 2022-05-16
- Completion
- 2022-08-22
- First posted
- 2018-04-18
- Last updated
- 2022-09-23
Locations
22 sites across 5 countries: Belgium, Finland, France, Germany, Spain
Source: ClinicalTrials.gov record NCT03500939. Inclusion in this directory is not an endorsement.