NCT03260153

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

January 5, 2017

Last Update Submit

August 28, 2017

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral HemorrhagePerihematomal edemaDeproteinised Calf Blood Serum Injection

Outcome Measures

Primary Outcomes (3)

  • Changes of cytotoxic and vasogenic edema on day 3 and day 7-10 (MRI evaluation)

    day 3, day 7-10

  • Changes of vasogenic edema on day 14 (CT evaluation)

    day 14

  • Changes of the biomarkers（MMP3、MMP9、TNF-α、IL-6、CRP） in the peripheral blood on different time course.

    at admission, day 3，day 3-7，day 14，day 30, day 90

Secondary Outcomes (5)

  • Clinical outcome evaluated by Glasgow Coma Scale(GCS)scores.

    at admission, day 14， day 30， day 90

  • Clinical outcome evaluated by NIH Stroke Scale(NIHSS)scores.

    at admission, day 14， day 30， day 90

  • Clinical outcome evaluated by Barthel Index(BI) scores.

    day 14， day 30， day 90

  • Clinical outcome evaluated by Modified Rankin Scale(mRS)scores.

    at admission, day 14， day 30， day 90

  • Clinical outcome evaluated by Stroke Impact Scale (SIS) scores.

    day 90

Study Arms (2)

Deproteinised Calf Blood Serum Injection

EXPERIMENTAL

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.

Drug: Deproteinised Calf Blood Serum Injection

Sodium Chloride Physiological Solution

PLACEBO COMPARATOR

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.

Drug: Placebo (Sodium Chloride)

Interventions

Deproteinised Calf Blood Serum InjectionDRUG
Deproteinised Calf Blood Serum Injection
Placebo (Sodium Chloride)DRUG
Sodium Chloride Physiological Solution

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Xingquan Zhao, MD

CONTACT

8610-67098891zxq@vip.163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology and Stroke Center

Study Record Dates

First Submitted

January 5, 2017

First Posted

August 24, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

CN(1)