Deferoxamine and Xingnaojing Injection Treatment in Intracerebral Hemorrhage

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capital Medical University
• Collaborators: 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; 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
• Treatments: Deferoxamine

Criteria

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