Intracerebral HemorrhageNCT03260153
Deproteinised Calf Blood Serum Injection for the Treatment of Acute Intracerebral Hemorrhage
A study testing Deproteinised Calf Blood Serum Injection in people with Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Deproteinised Calf Blood Serum Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Xingquan Zhao, MD, 8610-67098891, zxq@vip.163.com
About this study
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).
Read the 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.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Deproteinised Calf Blood Serum Injection, Placebo (Sodium Chloride)
- Keywords
- Intracerebral Hemorrhage, Perihematomal edema, Deproteinised Calf Blood Serum Injection
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deproteinised Calf Blood Serum InjectionDrug
Placebo (Sodium Chloride)Drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo (Sodium Chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of cytotoxic and vasogenic edema on day 3 and day 7-10 (MRI evaluation)
Measured: day 3, day 7-10
Changes of vasogenic edema on day 14 (CT evaluation)
Measured: day 14
Changes of the biomarkers（MMP3、MMP9、TNF-α、IL-6、CRP） in the peripheral blood on different time course.
Measured: 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.
Measured: at admission, day 14， day 30， day 90
Clinical outcome evaluated by NIH Stroke Scale(NIHSS)scores.
Measured: at admission, day 14， day 30， day 90
Clinical outcome evaluated by Barthel Index(BI) scores.
Measured: day 14， day 30， day 90
Clinical outcome evaluated by Modified Rankin Scale(mRS)scores.
Measured: at admission, day 14， day 30， day 90
Clinical outcome evaluated by Stroke Impact Scale (SIS) scores.
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study startJan 2017
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Stroke Association
- Responsible party
- Principal investigator, Xingquan Zhao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260153
- Sponsor's protocol ID
- CBS-ICH
- Status last verified
- Aug 2017
- First submitted
- 5 Jan 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deproteinised Calf Blood Serum Injection for the Treatment of Acute Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT03260153
- Acronym / sponsor ID
- CBS-ICH
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage, Perihematomal edema, Deproteinised Calf Blood Serum Injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Stroke Association
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deproteinised Calf Blood Serum Injection | Experimental | Drug: Deproteinised Calf Blood Serum InjectionParticipants will be randomly assigned to receive Deproteinised Calf Blood Serum Injection or placebo within 1 hour after randomization, once a day for 14 days. |
| Sodium Chloride Physiological Solution | Placebo comparator | Drug: Placebo (Sodium Chloride)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deproteinised Calf Blood Serum Injection | Drug | Deproteinised Calf Blood Serum Injection |
| Placebo (Sodium Chloride) | Drug | Sodium Chloride Physiological Solution |
Primary outcome
Changes of cytotoxic and vasogenic edema on day 3 and day 7-10 (MRI evaluation)
Time frame: day 3, day 7-10
Changes of vasogenic edema on day 14 (CT evaluation)
Time frame: day 14
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
5 secondary outcomes
Clinical outcome evaluated by Glasgow Coma Scale(GCS)scores.
Time frame: at admission, day 14， day 30， day 90
Clinical outcome evaluated by NIH Stroke Scale(NIHSS)scores.
Time frame: at admission, day 14， day 30， day 90
Clinical outcome evaluated by Barthel Index(BI) scores.
Time frame: day 14， day 30， day 90
Clinical outcome evaluated by Modified Rankin Scale(mRS)scores.
Time frame: at admission, day 14， day 30， day 90
Clinical outcome evaluated by Stroke Impact Scale (SIS) scores.
Time frame: day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deproteinised Calf Blood Serum Injection in people with Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xingquan Zhao, MD (8610-67098891, zxq@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of cytotoxic and vasogenic edema on day 3 and day 7-10 (MRI evaluation) (time frame: day 3, day 7-10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.