drugset / Trial / NCT03882060
Effect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients
RandomizedParallel-groupTriple-blindTreatment
Summary
This study evaluates the effect of recombinant human erythropoietin (rHuEPO) on the neovascularization of pediatric moyamoya disease patients. rHuEPO will be administrated during perioperative period of the first revascularization surgery. Primary outcome (Incidence of Good postoperative MCA territory revascularization by cerebral angiography) will be evaluated after 3-6 month of revascularization surgery.
Timeline
- Start
- 2019-04-08
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
Publications
- Background Hong JM, Lee SJ, Lee JS, Choi MH, Lee SE, Choi JW, Lim YC. Feasibility of Multiple Burr Hole With Erythropoietin in Acute Moyamoya Patients. Stroke. 2018 May;49(5):1290-1295. doi: 10.1161/STROKEAHA.117.020566. Epub 2018 Apr 6.
- Background Malla RR, Asimi R, Teli MA, Shaheen F, Bhat MA. Erythropoietin monotherapy in perinatal asphyxia with moderate to severe encephalopathy: a randomized placebo-controlled trial. J Perinatol. 2017 May;37(5):596-601. doi: 10.1038/jp.2017.17. Epub 2017 Mar 9.
- Background Kimakova P, Solar P, Solarova Z, Komel R, Debeljak N. Erythropoietin and Its Angiogenic Activity. Int J Mol Sci. 2017 Jul 13;18(7):1519. doi: 10.3390/ijms18071519.
- Background Aljaaly HA, Aldekhayel SA, Diaz-Abele J, Karunanayka M, Gilardino MS. Effect of Erythropoietin on Transfusion Requirements for Craniosynostosis Surgery in Children. J Craniofac Surg. 2017 Jul;28(5):1315-1319. doi: 10.1097/SCS.0000000000003717.
- Background Wu YW, Mathur AM, Chang T, McKinstry RC, Mulkey SB, Mayock DE, Van Meurs KP, Rogers EE, Gonzalez FF, Comstock BA, Juul SE, Msall ME, Bonifacio SL, Glass HC, Massaro AN, Dong L, Tan KW, Heagerty PJ, Ballard RA. High-Dose Erythropoietin and Hypothermia for Hypoxic-Ischemic Encephalopathy: A Phase II Trial. Pediatrics. 2016 Jun;137(6):e20160191. doi: 10.1542/peds.2016-0191. Epub 2016 May 2.
- Background Bang OY, Fujimura M, Kim SK. The Pathophysiology of Moyamoya Disease: An Update. J Stroke. 2016 Jan;18(1):12-20. doi: 10.5853/jos.2015.01760. Epub 2016 Jan 29.
- Background Kim T, Oh CW, Bang JS, Kim JE, Cho WS. Moyamoya Disease: Treatment and Outcomes. J Stroke. 2016 Jan;18(1):21-30. doi: 10.5853/jos.2015.01739. Epub 2016 Jan 29.
- Background Yoo YC, Shim JK, Kim JC, Jo YY, Lee JH, Kwak YL. Effect of single recombinant human erythropoietin injection on transfusion requirements in preoperatively anemic patients undergoing valvular heart surgery. Anesthesiology. 2011 Nov;115(5):929-37. doi: 10.1097/ALN.0b013e318232004b.
- Background Kim SK, Cho BK, Phi JH, Lee JY, Chae JH, Kim KJ, Hwang YS, Kim IO, Lee DS, Lee J, Wang KC. Pediatric moyamoya disease: An analysis of 410 consecutive cases. Ann Neurol. 2010 Jul;68(1):92-101. doi: 10.1002/ana.21981.
- Background Kim JH, Jung JH, Phi JH, Kang HS, Kim JE, Chae JH, Kim SJ, Kim YH, Kim YY, Cho BK, Wang KC, Kim SK. Decreased level and defective function of circulating endothelial progenitor cells in children with moyamoya disease. J Neurosci Res. 2010 Feb 15;88(3):510-8. doi: 10.1002/jnr.22228.
- Background Heeschen C, Aicher A, Lehmann R, Fichtlscherer S, Vasa M, Urbich C, Mildner-Rihm C, Martin H, Zeiher AM, Dimmeler S. Erythropoietin is a potent physiologic stimulus for endothelial progenitor cell mobilization. Blood. 2003 Aug 15;102(4):1340-6. doi: 10.1182/blood-2003-01-0223. Epub 2003 Apr 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epoetin alfa | Protein / enzyme biologic | 500 iu/kg | Other |