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Deproteinised Calf Blood Serum Injection for the Treatment of Acute Intracerebral Hemorrhage

Primary Purpose

Intracerebral Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Deproteinised Calf Blood Serum Injection
Placebo (Sodium Chloride)
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Intracerebral Hemorrhage, Perihematomal edema, Deproteinised Calf Blood Serum Injection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of spontaneous intracerebral hemorrhage(sICH)
  2. Bleeding into deep gray matter (basal ganglionic and thalamus), and the amount of bleeding between 5 and 30 ml;
  3. Age between 18 and 80 years;
  4. Presentation within 48 hours of symptom onset, and NCCT at 24 hours need to be done in patients presenting within 24 hours of symptom onset in order to exclude hematoma expansion.
  5. Informed consent by patients or relatives.

Exclusion Criteria:

  1. Â secondary ICH (secondary to trauma, tumor, vascular malformations, ischemic stroke hemorrhagic transformation, etc.);
  2. Glasgow Coma Score of 3-8 at admission;
  3. Parenchymal hemorrhage with ventricle involved;
  4. Patients with hematoma expansion; .
  5. Planned surgery within 3 days of symptom onset;
  6. Incompletely absorbed brain hematoma previously;
  7. Prestroke modified Rankin score(mRS)>1;
  8. Patients with hemorrhagic disease or coagulation disorders;
  9. Patients with severe liver and renal insufficiency;.
  10. Patients with severe heart failure or other serious systemic diseases;
  11. Patients with malignant tumors or ongoing anti-tumor therapy;
  12. Patients with a history of dementia or mental disorders;
  13. Pregnant or lactating women or those who has a recent fertility plan;
  14. Any contraindications to MRI(such as cardiac pacemakers and other metal implants, claustrophobia);
  15. Any other neuroprotective has been applied before randomization;
  16. Terminal patients whose life expectancy <90 days;
  17. Patients participating in other clinical trials 30 days prior to randomization.

Sites / Locations

  • Beijing Tian Tan Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Deproteinised Calf Blood Serum Injection

Sodium Chloride Physiological Solution

Arm Description

Participants will be randomly assigned to receive Deproteinised Calf Blood Serum Injection or placebo within 1 hour after randomization, once a day for 14 days.

Participants will be randomly assigned to receive Deproteinised Calf Blood Serum Injection or placebo within 1 hour after randomization, once a day for 14 days.

Outcomes

Primary Outcome Measures

Changes of cytotoxic and vasogenic edema on day 3 and day 7-10 (MRI evaluation)
Changes of vasogenic edema on day 14 (CT evaluation)
Changes of the biomarkers(MMP3、MMP9、TNF-α、IL-6、CRP) in the peripheral blood on different time course.

Secondary Outcome Measures

Clinical outcome evaluated by Glasgow Coma Scale(GCS)scores.
Clinical outcome evaluated by NIH Stroke Scale(NIHSS)scores.
Clinical outcome evaluated by Barthel Index(BI) scores.
Clinical outcome evaluated by Modified Rankin Scale(mRS)scores.
Clinical outcome evaluated by Stroke Impact Scale (SIS) scores.

Full Information

First Posted
January 5, 2017
Last Updated
August 28, 2017
Sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Stroke Association
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1. Study Identification

Unique Protocol Identification Number
NCT03260153
Brief Title
Deproteinised Calf Blood Serum Injection for the Treatment of Acute Intracerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Stroke Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy and safety of Deproteinised Calf Blood Serum Injection in alleviating perihematomal edema (PHE) and secondary brain injury, as well as neurologic deficits in patients with acute intracerebral hemorrhage (ICH).
Detailed Description
The study hypothesized that administration of Deproteinised Calf Blood Serum Injection would alleviate PHE and secondary brain injury, thus improving clinical outcomes in patients with ICH. The investigators will enroll 60 acute supratentorial ICH patients. Patients will be assigned randomly to receive either Deproteinised Calf Blood Serum Injection or placebo treatment, which is blinded to evaluator and patients. All patients in the study will receive standard care treatment and clinical, diagnostic, laboratory, safety, and follow-up evaluations. Blood will be drawn and brain MRI will be done in different time course. Follow-up evaluations, including National Institute of Health stroke scale(NIHSS), Stroke impact scale , Glasgow Coma Scale ,Barthel index score and modified Rankin scale assessments, will be done periodically until 90 days after onset.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
Intracerebral Hemorrhage, Perihematomal edema, Deproteinised Calf Blood Serum Injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deproteinised Calf Blood Serum Injection
Arm Type
Experimental
Arm Description
Participants will be randomly assigned to receive Deproteinised Calf Blood Serum Injection or placebo within 1 hour after randomization, once a day for 14 days.
Arm Title
Sodium Chloride Physiological Solution
Arm Type
Placebo Comparator
Arm Description
Participants will be randomly assigned to receive Deproteinised Calf Blood Serum Injection or placebo within 1 hour after randomization, once a day for 14 days.
Intervention Type
Drug
Intervention Name(s)
Deproteinised Calf Blood Serum Injection
Intervention Type
Drug
Intervention Name(s)
Placebo (Sodium Chloride)
Primary Outcome Measure Information:
Title
Changes of cytotoxic and vasogenic edema on day 3 and day 7-10 (MRI evaluation)
Time Frame
day 3, day 7-10
Title
Changes of vasogenic edema on day 14 (CT evaluation)
Time Frame
day 14
Title
Changes of the biomarkers(MMP3、MMP9、TNF-α、IL-6、CRP) in the peripheral blood on different time course.
Time Frame
at admission, day 3,day 3-7,day 14,day 30, day 90
Secondary Outcome Measure Information:
Title
Clinical outcome evaluated by Glasgow Coma Scale(GCS)scores.
Time Frame
at admission, day 14, day 30, day 90
Title
Clinical outcome evaluated by NIH Stroke Scale(NIHSS)scores.
Time Frame
at admission, day 14, day 30, day 90
Title
Clinical outcome evaluated by Barthel Index(BI) scores.
Time Frame
day 14, day 30, day 90
Title
Clinical outcome evaluated by Modified Rankin Scale(mRS)scores.
Time Frame
at admission, day 14, day 30, day 90
Title
Clinical outcome evaluated by Stroke Impact Scale (SIS) scores.
Time Frame
day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of spontaneous intracerebral hemorrhage(sICH) Bleeding into deep gray matter (basal ganglionic and thalamus), and the amount of bleeding between 5 and 30 ml; Age between 18 and 80 years; Presentation within 48 hours of symptom onset, and NCCT at 24 hours need to be done in patients presenting within 24 hours of symptom onset in order to exclude hematoma expansion. Informed consent by patients or relatives. Exclusion Criteria: Â secondary ICH (secondary to trauma, tumor, vascular malformations, ischemic stroke hemorrhagic transformation, etc.); Glasgow Coma Score of 3-8 at admission; Parenchymal hemorrhage with ventricle involved; Patients with hematoma expansion; . Planned surgery within 3 days of symptom onset; Incompletely absorbed brain hematoma previously; Prestroke modified Rankin score(mRS)>1; Patients with hemorrhagic disease or coagulation disorders; Patients with severe liver and renal insufficiency;. Patients with severe heart failure or other serious systemic diseases; Patients with malignant tumors or ongoing anti-tumor therapy; Patients with a history of dementia or mental disorders; Pregnant or lactating women or those who has a recent fertility plan; Any contraindications to MRI(such as cardiac pacemakers and other metal implants, claustrophobia); Any other neuroprotective has been applied before randomization; Terminal patients whose life expectancy <90 days; Patients participating in other clinical trials 30 days prior to randomization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xingquan Zhao, MD
Phone
8610-67098891
Email
zxq@vip.163.com
Facility Information:
Facility Name
Beijing Tian Tan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingquan Zhao, MD
Phone
8610-67098891
Email
zxq@vip.163.com

12. IPD Sharing Statement

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Deproteinised Calf Blood Serum Injection for the Treatment of Acute Intracerebral Hemorrhage

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