Abstract TMP15: Penumbral Rescue by Normobaric O2 in Ischemic Stroke With Target Mismatch ProFile (PROOF)
Bibliographic record
Abstract
Introduction/Hypothesis: Despite effective reperfusion therapies, outcome following ischemic stroke (IS) often remains poor. Shortly after IS onset, the already necrotic area is surrounded by the severely hypoperfused but still viable penumbra. Sustaining the latter may widen treatment time windows and improve outcomes. As tissue damage in IS is primarily mediated by hypoxia, increasing penumbral oxygen (O2) supply seems a logical approach. Normobaric hyperoxygenation (NBHO) increased penumbral O2 and attenuated brain injury when initiated early in animal models of transient vessel occlusion. The few clinical trials conducted so far did not adapt these insights: NBHO initiation was late (treatment windows of more than 9 hours) and patients eligible for intravenous thrombolysis and endovascular treatment were excluded. Methods: Multi-center, randomized phase-II proof-of-concept trial studying NBHO adjunct to standard IS treatment; adaptive patient sample size of 180 to 460 depending on interim analysis. Eligibility: Patients with an acute large vessel occlusion in the anterior circulation (terminal ICA plus M1, proximal M1, or distal M1) and an Alberta Stroke Program Early CT Score of 7 or higher. Study treatment must be initiated prior to recanalization therapy and within 3 hours after IS onset. NBHO is achieved by administration of high-flow O2 (40 L/min) via non-rebreather face mask with reservoir or FiO2 of 1.0 during mechanical ventilation. NBHO will be stopped after endovascular treatment or applied for a maximum of four hours in case of not-attempted endovascular treatment. Controls will receive standard O2 supplementation whenever required. Primary Endpoint: Infarct growth from baseline to 24 hours; key secondary endpoint: Δ24h-NIHSS. Conclusion: PROOF is the first clinical trial to incorporate two cornerstones of effective experimental NBHO: early initiation and fast reperfusion. If proven beneficial, phase-III trials may be undertaken. Considering its low cost, NBHO may impact stroke care worldwide.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.015 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".