drugset / Trial / NCT02367248
Deferoxamine and Xingnaojing Injection Treatment in Intracerebral Hemorrhage
Phase 1/2
Unknown
180 enrolled
Capital Medical University
Beijing Aerospace General Hospital · collabBeijing Ditan Hospital · collabBeijing Fangshan District Liangxiang Hospital · collabBeijing Haidian Hospital · collabBeijing Jishuitan Hospital · collabBeijing Luhe Hospital · collabBeijing Neurosurgical Institute · collabBeijing Pinggu District Hospital · collabBeijing Shuyi Hospital · collabBeijing Tiantan Hospital · collabBeijing Youyi Hospital · collabChinese PLA General Hospital · collabGeneral Hospital of Beijing PLA Military Region · collabPeking University First Hospital · collabPeking University People's Hospital · collabPeking University Third Hospital · collabPeople's Hospital of Beijing Daxing District · collabThe 263 Hospital of PLA · collabThe Second Artillery General Hospital · collabXiyuan Hospital of China Academy of Chinese Medical Sciences · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The main purpose of this study is to determine whether deferoxamine and xingnaojing injection is effective and safe as a treatment for intracerebral hemorrhage.
Timeline
- Start
- 2015-03
- Primary completion
- 2016-12
- Completion
- 2016-12
Publications
- Background Okauchi M, Hua Y, Keep RF, Morgenstern LB, Schallert T, Xi G. Deferoxamine treatment for intracerebral hemorrhage in aged rats: therapeutic time window and optimal duration. Stroke. 2010 Feb;41(2):375-82. doi: 10.1161/STROKEAHA.109.569830. Epub 2009 Dec 31.
- Background Selim M. Deferoxamine mesylate: a new hope for intracerebral hemorrhage: from bench to clinical trials. Stroke. 2009 Mar;40(3 Suppl):S90-1. doi: 10.1161/STROKEAHA.108.533125. Epub 2008 Dec 8.
- Background Selim M, Yeatts S, Goldstein JN, Gomes J, Greenberg S, Morgenstern LB, Schlaug G, Torbey M, Waldman B, Xi G, Palesch Y; Deferoxamine Mesylate in Intracerebral Hemorrhage Investigators. Safety and tolerability of deferoxamine mesylate in patients with acute intracerebral hemorrhage. Stroke. 2011 Nov;42(11):3067-74. doi: 10.1161/STROKEAHA.111.617589. Epub 2011 Aug 25.
- Background Morgenstern LB, Hemphill JC 3rd, Anderson C, Becker K, Broderick JP, Connolly ES Jr, Greenberg SM, Huang JN, MacDonald RL, Messe SR, Mitchell PH, Selim M, Tamargo RJ; American Heart Association Stroke Council and Council on Cardiovascular Nursing. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2010 Sep;41(9):2108-29. doi: 10.1161/STR.0b013e3181ec611b. Epub 2010 Jul 22.
- Background Chaudhary N, Gemmete JJ, Thompson BG, Xi G, Pandey AS. Iron--potential therapeutic target in hemorrhagic stroke. World Neurosurg. 2013 Jan;79(1):7-9. doi: 10.1016/j.wneu.2012.11.048. Epub 2012 Nov 19. No abstract available.
- Background Demchuk AM, Dowlatshahi D, Rodriguez-Luna D, Molina CA, Blas YS, Dzialowski I, Kobayashi A, Boulanger JM, Lum C, Gubitz G, Padma V, Roy J, Kase CS, Kosior J, Bhatia R, Tymchuk S, Subramaniam S, Gladstone DJ, Hill MD, Aviv RI; PREDICT/Sunnybrook ICH CTA study group. Prediction of haematoma growth and outcome in patients with intracerebral haemorrhage using the CT-angiography spot sign (PREDICT): a prospective observational study. Lancet Neurol. 2012 Apr;11(4):307-14. doi: 10.1016/S1474-4422(12)70038-8. Epub 2012 Mar 8.
- Background Gu Y, Hua Y, Keep RF, Morgenstern LB, Xi G. Deferoxamine reduces intracerebral hematoma-induced iron accumulation and neuronal death in piglets. Stroke. 2009 Jun;40(6):2241-3. doi: 10.1161/STROKEAHA.108.539536. Epub 2009 Apr 16.
- Background Okauchi M, Hua Y, Keep RF, Morgenstern LB, Xi G. Effects of deferoxamine on intracerebral hemorrhage-induced brain injury in aged rats. Stroke. 2009 May;40(5):1858-63. doi: 10.1161/STROKEAHA.108.535765. Epub 2009 Mar 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Deferoxamine | Other / unclassified | 40 mg/kg | Intravenous |
| Comparator | Xingnaojing injection | Unknown | 20 ml | Intravenous |