Intracerebral Hemorrhage Clinical Trial
NCT number | NCT03260153 |
Other study ID # | CBS-ICH |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | January 5, 2017 |
Last updated | August 28, 2017 |
Start date | January 2017 |
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).
Status | Recruiting |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tian Tan Hospital, Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital | Beijing Stroke Association |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of cytotoxic and vasogenic edema on day 3 and day 7-10 (MRI evaluation) | day 3, day 7-10 | ||
Primary | Changes of vasogenic edema on day 14 (CT evaluation) | day 14 | ||
Primary | Changes of the biomarkers(MMP3?MMP9?TNF-a?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 | Clinical outcome evaluated by Glasgow Coma Scale(GCS)scores. | at admission, day 14, day 30, day 90 | ||
Secondary | Clinical outcome evaluated by NIH Stroke Scale(NIHSS)scores. | at admission, day 14, day 30, day 90 | ||
Secondary | Clinical outcome evaluated by Barthel Index(BI) scores. | day 14, day 30, day 90 | ||
Secondary | Clinical outcome evaluated by Modified Rankin Scale(mRS)scores. | at admission, day 14, day 30, day 90 | ||
Secondary | Clinical outcome evaluated by Stroke Impact Scale (SIS) scores. | day 90 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05089331 -
ROSE-Longitudinal Assessment With Neuroimaging
|
||
Recruiting |
NCT03605381 -
MORbidity PRevalence Estimate In StrokE
|
||
Active, not recruiting |
NCT04522102 -
Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral haemorrhaGe (ASPIRING)-Pilot Phase
|
Phase 3 | |
Terminated |
NCT04178746 -
PRONTO: Artemis in the Removal of Intraventricular Hemorrhage in the Hyper-Acute Phase
|
||
Not yet recruiting |
NCT03956485 -
Multicentre Registry of Patients With Spontaneous Acute Intracerebral Hemorrhage in Catalonia (HIC-CAT).
|
||
Enrolling by invitation |
NCT02920645 -
Multicenter Validation of the AVICH Score
|
N/A | |
Recruiting |
NCT02625948 -
Tranexamic Acid for Acute ICH Growth prEdicted by Spot Sign
|
Phase 2 | |
Completed |
NCT02478177 -
Addressing Real-world Anticoagulant Management Issues in Stroke
|
||
Completed |
NCT01971359 -
Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study
|
N/A | |
Terminated |
NCT00990509 -
Albumin for Intracerebral Hemorrhage Intervention
|
Phase 2 | |
Completed |
NCT01261091 -
Early Tracheostomy in Ventilated Stroke Patients
|
N/A | |
Completed |
NCT00716079 -
The Second Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial
|
N/A | |
Recruiting |
NCT00222625 -
rFVIIa in ICH in Patients Treated With Anticoagulants or Anti-Platelets
|
Phase 2 | |
Recruiting |
NCT05095857 -
The Anesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury
|
Phase 4 | |
Recruiting |
NCT04548596 -
NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
|
||
Not yet recruiting |
NCT06429332 -
International Care Bundle Evaluation in Cerebral Hemorrhage Research
|
Phase 4 | |
Recruiting |
NCT05492474 -
Cranial Ultrasound for Prehospital ICH Diagnosis
|
N/A | |
Not yet recruiting |
NCT05502874 -
Multicenter Registry for Assessment of Markers of Early Neurological Deterioration in Primary Intracerebral Hemorrhage
|
||
Recruiting |
NCT04604587 -
MRI-visible Enlarged Perivascular Spaces and the Alteration of Lymphatic Drainage System in CAA
|
Phase 3 | |
Recruiting |
NCT05504941 -
Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage
|
N/A |