ArticleStroke (Hoboken, N.J.)2024
HEMERA 1 CarboxyHEMoglobin oxygEn delivery for Revascularization in Acute Stroke: A Prospective, Randomized Phase 1 Clinical Trial.
Article in Stroke (Hoboken, N.J.), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04677777 (A Randomized, Phase 1, Contemporaneously Controlled, Multicenter Study to Assess the Safety of PP-007 in Subjects With Acute Ischemic Stroke), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Phase 1, Contemporaneously Controlled, Multicenter Study to Assess the Safety of PP-007 in Subjects With Acute Ischemic Stroke (HEMERA-1)
Who cites it
3 citing papers in PubMed.
- Neuroprotection with Hemoglobin-based Oxygen Carriers in Ischemic Stroke: A Narrative Review of Preclinical Studies.JMA journal · 2026Review
- Hemoglobin-based oxygen carriers: Biochemical, biophysical differences, and safety.Transfusion · 2025Article
- Therapeutic delivery of oxygen using artificial oxygen carriers demonstrates the possibility of treating a wide range of diseases.Journal of nanobiotechnology · 2025Review
Corrections and comments
- Erratum issued
Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: PP-007 is a polyethylene glycol (PEG)ylated 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. Methods: HEMERA-1 (CarboxyHEMoglobin OxygEn delivery for Revascularization in Acute Stroke) was a multicenter, prospective, randomized, controlled phase 1 clinical trial. Anterior circulation large vessel occlusion patients were assigned in a 3:1 ratio to receive either PP-007 (320 mg/kg: 30 min bolus followed by 2-h infusion) plus MT or MT alone within 24 hours after symptom onset. Comprehensive safety evaluation was performed by independent Data Monitoring Safety Board and Imaging Core Lab. Results: From October 1, 2021 to June 30, 2022, a total of 17 patients were recruited. Age, baseline National Institutes of Health Stroke Scale score, and Alberta Stroke Program Early CT Score were 74.8±12.7 years, 17.3±4.2, and 7.9±1.8, respectively. Twelve patients were randomized to 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. A transient systolic blood pressure increase (20-40 mm Hg) 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-007 in patients undergoing MT. (The study was funded by Prolong Pharmaceuticals. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04677777.
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Registered trials
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