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Neuroprotectant for Hypertensive Intracerebral Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03546283
Recruitment Status : Not yet recruiting
First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Rong Hu, MD, Southwest Hospital, China

Brief Summary:
Cattle encephalon glycoside and ignotin Cattle encephalon glycoside and ignotin (CEGI) injection (drug approval H22025046; Jilin Sihuan Pharmaceutical Co. LTD., Jilin, People's Republic of China) is a compound preparation of muscle extract from healthy rabbits and cattle brain gangliosides, which was approved by the Chinese Food and Drug Administration in 2011 and was commonly used as neuroprotectant in the treatment of central and peripheral nerve injuries in China. To evaluate the safety and efficacy of CEGI in treatment of Hypertensive intracerebral hemorrhage, we designed this study.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: Placebos Drug: Cattle Encephalon Glycoside and Ignotin Phase 3

Detailed Description:

Hypertensive intracerebral hemorrhage (HICH) is a type of stroke that is caused by hypertension-induced intracranial arterial, venous, and capillary ruptures. In recent years, the incidence of HICH has become higher, which has exposed society greatly to heavy social and economic burdens. Therefore it is necessary to find therapeutic strategies. ICH causes primary white matter injury by direct mechanical compression and hematoma expansion, and then it induces secondary injury through toxic product from the blood out of the vessel. The inflammatory response that follows ICH also contributes to the white matter injury. Additionally, post-ICH complications that include cortical thinning, cerebral edema, and hydrocephalus further aggravate the subcortical white matter damage.

The complex injury mechanisms that follow ICH implies that a multi-target neuroprotective agent might be able to achieve better neuroprotective effects than current single-agent neuroprotective therapies.

Cattle encephalon glycoside and ignotin Cattle encephalon glycoside and ignotin (CEGI) injection (drug approval H22025046; Jilin Sihuan Pharmaceutical Co. LTD., Jilin, People's Republic of China) is a multi-target neuroprotective agent that includes polypeptides, various gangliosides, free amino acids and nucleic acids, which were extracted from muscle tissue of healthy rabbits and cattle brain gangliosides, and was approved by the Chinese Food and Drug Administration in 2011, commonly used as neuroprotectant in the treatment of central and peripheral nerve injuries in China.

It has been proven by basic research that CEGI treatment significantly alleviated the neurobehavioral dysfunction, promoted hematoma absorption, effectively up-regulated MBP/MAP-2 expression, and ameliorated white matter fiber damage [1]. CEGI was frequently used in the treatment of intracerebral hemorrhage, yet there is still a lack of high quality study to demonstrate its clinical efficacy. To achieve more clinical evidence of CEGI in treatment of Hypertensive intracerebral hemorrhage, we designed this study to further evaluate the efficacy and safety of CEGI in the treatment of Hypertensive intracerebral hemorrhage.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Neuroprotectant Cattle Encephalon Glycoside and Ignotin Injection for Intracerebral Hemorrhage: a Multicenter, Randomized, Double-blinded, Placebo-controlled Trial.
Estimated Study Start Date : June 15, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Placebo Comparator: Control
The patients with hypertensive intracerebral hemorrhage will be randomized into giving placebo group, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage.
Drug: Placebos
The patients with hypertensive intracerebral hemorrhage will be randomized into giving placebos, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage.

Experimental: CEGI treatment
The patients with hypertensive intracerebral hemorrhage will be randomized into giving drug CEGI, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage.
Drug: Cattle Encephalon Glycoside and Ignotin
The patients with hypertensive intracerebral hemorrhage will be randomized into giving CEGI, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage.




Primary Outcome Measures :
  1. GOSE at 90 days [ Time Frame: 90 days after onset ]
    Glasgow Outcome Scale Extended at 90 days


Secondary Outcome Measures :
  1. GOSE at 30 days [ Time Frame: 30 days after onset ]
    Glasgow Outcome Scale Extended at 30 days

  2. Score of mRS at 14days, 30 days and 90 days [ Time Frame: 14 days, 30 days and 90 days after onset ]
    Global functional performance after stroke in terms of mRS at 14 days, 30 Days and 90 Days, respectively: 0 - No symptoms.1- No significant disability. Able to carry out all usual activities, despite some symptoms.2- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3- Moderate disability. Requires some help, but able to walk unassisted.4- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6- Dead.

  3. Score of NIHSS at 14days, 30 days and 90 days [ Time Frame: 14 days, 30 days and 90 days after onset ]
    Global functional performance after stroke in terms of NIH Stroke Scale at 14 Days, 30 Days, and 90 Days, respectively: (0 = best possible, highest number = best possible) in areas of motor control of the arm (0-4), leg (0-4) sensory perception (0-2), language (0-3), limb ataxia (0-2), gaze (0-2), level of consciousness (0-3), level of consciousness -orientation (0-2), level of consciousness -commands (0-2), facial palsy (0-3), visual (0-3), dysarthria (0-2), and extinction (0-2).

  4. Score of Barthel Index at 14days, 30 days and 90 days [ Time Frame: 14 days, 30 days and 90 days after onset ]
    Global functional performance after stroke in terms of Barthel Index (scores 0~100) at 14 Days, 30 Days, and 90 Days, respectively: scores 100 mean good daily living ability; scores above 60 mean mild function disability that can live independently most time; scores between 60~41 mean moderate function disability that need some help in daily life; scores below 20 mean total disability that live helplessly.

  5. Complications [ Time Frame: within 90 days after onset ]
    Complications incidence including epilepsy, hydrocephalus, cerebral infarction, blooding recurrence, pneumonia and gastrointestinal bleeding



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Individuals aged 18-75 years;
  2. Newly diagnosed hypertensive intracerebral hemorrhage, bleeding position localizes in Basal ganglia and bleeding volume is within 25-50ml evaluated by head CT, and the hemorrhage does not break into lateral ventricle;
  3. Obvious neurological dysfunction after onset, Glasco Comma Scale evaluation between 5-14, or NIHSS above 6, but without signs of cerebral hernia.
  4. Enrolled within 72 hours after onset, and CT examination shows no hematomas expansion within 6 hours or above after diagnostic CT (hematoma expansion ≤ 5ml);
  5. Written informed consent can be obtained.

Exclusion Criteria:

  1. Diagnosed with intracerebral hemorrhage caused by aneurysm, brain tumor, trauma, cerebral parasitic disease, cerebrovascular malformation, moyamoya disease, cerebral arteritis, hematological diseases, or metabolic disorders;
  2. Patients whose hematoma is unstable or progress leading to increased intracranial pressure;
  3. Ever diagnosed with subarachnoid hemorrhage and ischemic stroke;
  4. Ever received anticoagulants or antiplatelet drug treatment within one month prior to onset;
  5. Abnormal coagulation function (platelet count <100×109/L, INR>1.4);
  6. Patients who need operation treatment (including external ventricular drainage);
  7. Patients who may suffer from mental or physical diseases that disturb outcome evaluation;
  8. blood homocysteine higher than 15μmol/L when admission;
  9. Patients who have serious diseases in heart, lung, liver, kidney, endocrine or hemopoietic system;
  10. Allergic to protein or peptide;
  11. Drug or alcohol addiction;
  12. Pregnant women (positive in pregnancy test or lactating women)
  13. Participated in other clinical trials within 3 months;
  14. Patients considered as not suitable for clinical trials by researchers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546283


Locations
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China, Chongqing
Department of Neurosurgery , Southwest Hospital, Third Military Medical University,
Chongqing, Chongqing, China, 400038
Sponsors and Collaborators
Rong Hu, MD
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Responsible Party: Rong Hu, MD, Director of neurosurgery, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT03546283    
Other Study ID Numbers: Neurosurg 04
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cardiac Glycosides
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs