Intracerebral Hemorrhage Clinical Trial
Official title:
Safety and Effectiveness Study of Deferoxamine and Xingnaojing Injection in Intracerebral Hemorrhage
The main purpose of this study is to determine whether deferoxamine and xingnaojing injection is effective and safe as a treatment for intracerebral hemorrhage.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Age = 18 and = 80 years 2. The diagnosis of ICH is confirmed by brain CT scan 3. NIHSS score = 6 and GCS > 6 upon presentation 4. The first dose of the study drug can be administered within 12h of ICH symptom onset 5. Functional independence prior to ICH, defined as pre-ICH mRS = 1 6. Signed and dated informed consent is obtained. Exclusion Criteria: 1. Known hypersensitivity to deferoxamine or xingnaojing injection 2. Known severe iron deficiency anemia (defined as hemoglobin concentration < 7g/dL or requiring blood transfusions) 3. Abnormal renal function, defined as serum creatinine > 2 mg/dL 4. Planned surgical evacuation of ICH prior to administration of study drug 5. Suspected secondary ICH related to tumour, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis 6. Infratentorial hemorrhage 7. Irreversibly impaired brainstem function (bilateral fixed and dilated pupils and extensor motor posturing) 8. Complete unconsciousness, defined as a score of 3 on item 1a of the NIHSS (Responds only with reflex motor or autonomic effects or totally unresponsive, and flaccid) 9. Pre-existing disability, defined as pre-ICH mRS = 2 10. Coagulopathy - defined as elevated aPTT or INR >1.3 upon presentation; concurrent use of direct thrombin inhibitors (such as dabigatran), direct factor Xa inhibitors (such as rivaroxaban), or low-molecular-weight heparin 11. Taking iron supplements containing = 325 mg of ferrous iron 12. Patients with heart failure taking > 500 mg of vitamin C daily 13. Known severe hearing loss 14. Known pregnancy, or positive pregnancy test, or breastfeeding 15. Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, noncompliance, living in another state or any other cause 16. Life expectancy of less than 90 days due to comorbid conditions |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Neurology,Beijing Shijitan Hospital,Capital Medical University | Beijing |
Lead Sponsor | Collaborator |
---|---|
Capital Medical University | Beijing Aerospace General Hospital, Beijing Ditan Hospital, Beijing Fangshan District Liangxiang Hospital, Beijing Haidian Hospital, Beijing Jishuitan Hospital, Beijing Luhe Hospital, Beijing Neurosurgical Institute, Beijing Pinggu District Hospital, Beijing Shuyi Hospital, Beijing Tiantan Hospital, Beijing Youyi Hospital, Chinese PLA General Hospital, General Hospital of Beijing PLA Military Region, Peking University First Hospital, Peking University People's Hospital, Peking University Third Hospital, People’s Hospital of Beijing Daxing District, The 263 Hospital of PLA, The Second Artillery General Hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences |
China,
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. — View Citation
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. Erratum in: Lancet Neurol. 2012 Jun;11(6):483. — View Citation
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. — View Citation
Morgenstern LB, Hemphill JC 3rd, Anderson C, Becker K, Broderick JP, Connolly ES Jr, Greenberg SM, Huang JN, MacDonald RL, Messé 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numbers of patients with the perihematomal edema (PHE) volume variation. | decreases of more than 20% from initial PHE volumes were defined as "decreased" PHE volume; increases of more than 20% from initial PHE volumes were defined as "increased" PHE volume; changes between -20% and 20% were defined as "unchanged". | 7 days | No |
Secondary | The residual cavity volume | the variation of residual cavity volume of | 90 days | No |
Secondary | The variation of the mRS score and the Bathel Index | the variation of mRS score and Bathel Index of different treated subjects from ICH onset to treatment time windows. | 90 days | No |
Secondary | mortality | the mortality of different treated subjects from ICH onset to treatment time windows. | 90 days | Yes |
Secondary | Frequency of Treatment-related Adverse Events | The safety endpoints will include all DFO-related adverse events until day-7 or discharge (whichever is earlier), and DFO-related SAEs and through day-90. | 90 days | Yes |
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