LB-005 Hemera 1 carboxyhemoglobin oxygendelivery for revascularization in acute stroke: a prospective, randomized phase 1 clinical trial
Bibliographic record
Abstract
Background PP-007 is a PEGylated bovine carboxyhemoglobin gas transfer molecule with pleotropic cytoprotective effects, vasodilatation, plasma expansion and optimization of oxygen delivery. Rodent middle cerebral artery occlusion models have demonstrated that PP-007 increases blood flow in the collateral circulation and reduces final infarct volumes, supporting a potential role as neuroprotective agent in acute ischemic stroke. We aim to evaluate the safety and feasibility of PP-007 as an adjunctive treatment to mechanical thrombectomy (MT) in patients with stroke secondary to large vessel occlusion (LVO). Methods HEMERA-1 was a multicenter, prospective, randomized, controlled phase 1 clinical trial. Anterior circulation LVO patients were assigned in a 3:1 ratio to receive either PP-007 (320mg/kg: 30 minutes bolus followed by 2-hour infusion) plus MT or MT alone within 24 hours after symptom onset. Other key inclusion criteria were baseline NIHSS ≥6, baseline Alberta Stroke Program Early CT Score (ASPECTS) ≥5 and/or estimated core volumes ≤70mL with mismatch >50mL on CT perfusion, pre-morbid modified Rankin Scale <2, and ineligibility for intravenous thrombolysis. The primary endpoint comprised a comprehensive safety evaluation by a Data Monitoring Safety Board. Results A total of 17 patients were recruited. The mean ± SD age, baseline NIHSS, and ASPECTS were 74.8±12.7 years, 17.3±4.2, and 7.9±1.8, respectively. Twelve patients were randomized PP-007 plus MT, 1 was randomized but not treated, 4 patients were randomized to MT alone. Recanalization of the occluded vessel was achieved in all patients. Seven PP-007 patients in 2 centers had temporary elevation of Partial Prothrombin Time most likely artifactual without any clinical consequences. A transient systolic blood pressure increase (20-40 mmHg) during the bolus was observed in all PP-007 patients without any clinical consequences. There were no other safety concerns. Conclusion No significant safety concerns were identified for the adjunctive use of PP-007in patients undergoing MT (ClinicalTrials.gov NCT04677777). Disclosures I. Linfante: 2; C; Penumbra, Stryker, Q’Appel, Cerenovus. 3; C; Penumbra, Stryker, Q’Appel, Cerenovus. 4; C; Prolong Pharmaceuticals, InNeuroCo,Three Rivers, InNeuroFine, Deinde. W. Clark: None. D. Houssen: None. R. Hanel: None. R. Reshi: None. G. Dabus: 4; C; three rivers, InNeuroCo, synchron. R. Jubin: 5; C; Prolong Pharmaceuticals. T. Nguyen: None. J. Grotta: None. R. Wicks: None. M. Pervez: None. M. Cipolla: None. D. Liebeskind: None. R. Nogueira: None.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| 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 | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
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".