Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits

Phase 2 Completed 44 enrolled Ajou University School of Medicine Dong-A Pharmaceutical Co., Ltd. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in patients with cerebral perfusion deficits (NIMBUS trial)

Timeline

Start: 2016-07-15
Primary completion: 2019-07-16
Completion: 2019-12-31

Outcome

Met primary endpoint

paper Significantly, more cases of trans-hemispheric (19/21 [90.5%] versus 12/21 [57.1%]) PMID 35579016 ↗

paper and trans-burr hole (42/58 [72.4%] versus 30/58 [51.7%]) PMID 35579016 ↗

Publications

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Background Ehrenreich H, Weissenborn K, Prange H, Schneider D, Weimar C, Wartenberg K, Schellinger PD, Bohn M, Becker H, Wegrzyn M, Jahnig P, Herrmann M, Knauth M, Bahr M, Heide W, Wagner A, Schwab S, Reichmann H, Schwendemann G, Dengler R, Kastrup A, Bartels C; EPO Stroke Trial Group. Recombinant human erythropoietin in the treatment of acute ischemic stroke. Stroke. 2009 Dec;40(12):e647-56. doi: 10.1161/STROKEAHA.109.564872. Epub 2009 Oct 15.
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Hong JM, Choi MH, Park GH, Shin HS, Lee SJ, Lee JS, Lim YC. Transdural Revascularization by Multiple Burrhole After Erythropoietin in Stroke Patients With Cerebral Hypoperfusion: A Randomized Controlled Trial. Stroke. 2022 Sep;53(9):2739-2748. doi: 10.1161/STROKEAHA.122.038650. Epub 2022 May 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	epoetin alfa	Protein / enzyme biologic	33000 iu	Intravenous