Neuroprotectant for Hypertensive Intracerebral Hemorrhage

NCT03546283 | Unknown Phase 3

• 1 other identifier: Neurosurg 04
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• GOSE at 90 days

  Glasgow Outcome Scale Extended at 90 days

  90 days after onset

Secondary Outcomes (5)

• GOSE at 30 days

  30 days after onset

• Score of mRS at 14days, 30 days and 90 days

  14 days, 30 days and 90 days after onset

• Score of NIHSS at 14days, 30 days and 90 days

  14 days, 30 days and 90 days after onset

• Score of Barthel Index at 14days, 30 days and 90 days

  14 days, 30 days and 90 days after onset

• Complications

  within 90 days after onset

Study Arms (2)

Control

PLACEBO COMPARATOR

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

CEGI treatment

EXPERIMENTAL

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

Interventions

Placebos DRUG

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.

Control

Cattle Encephalon Glycoside and Ignotin DRUG

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.

CEGI treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18-75 years;
• 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;
• Obvious neurological dysfunction after onset, Glasco Comma Scale evaluation between 5-14, or NIHSS above 6, but without signs of cerebral hernia.
• Enrolled within 72 hours after onset, and CT examination shows no hematomas expansion within 6 hours or above after diagnostic CT (hematoma expansion ≤ 5ml);
• Written informed consent can be obtained.

You may not qualify if:

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

Sponsors & Collaborators

• Rong Hu, MD: lead

Study Sites (1)

Department of Neurosurgery , Southwest Hospital, Third Military Medical University,

Chongqing, Chongqing Municipality, 400038, China

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of neurosurgery

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 6, 2018
• Study Start: June 15, 2018
• Primary Completion: July 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

CN (1)