Acute Stroke, Intracerebral Hemorrhage
Conditions
Keywords
Therapy, Neuroprotection
Brief summary
Intracerebral hemorrhage (ICH) results from the rupture of small vessels damaged by chronic hypertension, amyloid angiopathy or other disease. Currently, ICH has been a devastating type of stroke that lacking effective therapy. Remote ischemic conditioning (RIC), a systematically protective strategy, has been found to have neuroprotective effects by in patients with ischemic stroke. In addition, animal studies show that RIC is safe in ICH model and it could accelerate the absorption of hematoma. In a previous clinical study (RICH-1), RIC have been found to be safe and well-tolerated in patients with ICH. Therefore, the investigators plan to undertake this study to further evaluate the safety and efficacy of RIC in patients with ICH. The investigators hypothesize that treatment with RIC will accelerate the absorption of hematoma and improve patients' functional outcomes. Results of this study can potentially bring into account new means to improve the outcomes of ICH patients.
Interventions
Standard medication therapy will be performed according to the national and international guidelines.
DEVICERemote ischemic conditioning
RIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed once daily for consecutive 7 days after enrollment.
DEVICESham remote ischemic conditioning
Sham RIC will be performed by the same electric autocontrol device with cuff placed on arm. Sham RIC procedures consist of five cycles of 5-min inflation (30 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed once daily for consecutive 7 days after enrollment.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 and ≤ 80 years 2. The diagnosis of supratentorial ICH is confirmed by brain CT scan 3. Hematoma volume of 10 to 30 ml and Glasgow Coma Score (GCS)\>8 at randomization. 4. National Institutes of Health Stroke Scale (NIHSS)≥6 and ≤20 points at randomization. 5. Randomization and starting treatment between 24 and 48 hours of symptom ictus. 6. Signed and dated informed consent is obtained.
Exclusion criteria
1. Planned surgical evacuation of ICH prior to administration of investigational intervention 2. ICH concomitant with subarachnoid hemorrhage or intraventricular hemorrhage 3. Suspected secondary ICH related to tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis 4. Patients with a pre-existing neurological deficit (mRS\>1) or psychiatric disease that would confound the neurological or functional evaluations. 5. Coagulopathy - defined as elevated aPTT or INR \>1.3 upon presentation; concurrent use of direct thrombin inhibitors (such as dabigatran), direct factor Xa inhibitors (such as rivaroxaban or apixaban), or low-molecular-weight heparin 6. Severe renal disease (i.e., renal disorder requiring dialysis ) or eGFR \<30ml/min/1.73m2 7. Severe liver disorder, or ALT \>3 times or bilirubin \>2 times upper limit of normal 8. Known severe hearing loss or cognitive impairment 9. Known pregnancy, or positive pregnancy test, or breastfeeding 10. Patients known or suspected of not being able to comply with the study protocol due to alcoholism, noncompliance or any other cause 11. Life expectancy of less than 90 days due to co-morbid conditions 12. Concurrent participation in another research protocol for investigation of another experimental therapy 13. Severe, sustained hypertension (Systolic blood pressure\> 180 mmHg or diastolic blood pressure\> 110 mmHg). 14. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs. 15. Any condition which, in the judgement of the investigator, might increase the risk to the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days | 0-90 days. | The mRS ranges from 0 to 6, with higher scores indicating worse outcome. The primary outcome measure is the mRS score, dichotomized to define favorable functional outcome as mRS 0-2 at 90 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With mRS Score 0-2 at 180 Days | 180 days | The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Another measure of efficacy is the mRS score, dichotomized to define good functional outcome as mRS 0-2 at 180 days. |
| Proportion of Patients With mRS Score 0-3 at 90 Days | 90 days | The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Another measure of efficacy is the mRS score, dichotomized to define good functional outcome as mRS 0-3 at 90 days. |
| Proportion of Patients With mRS Score 0-3 at 180 Days | 180 days | The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Another measure of efficacy is the mRS score, dichotomized to define good functional outcome as mRS 0-3 at 180 days. |
| Number of Subjects Experiencing Serious Adverse Events | 90 days | Number of subjects experiencing Serious adverse events at any time from randomization through day 90 |
| Number of Subjects With Serious Adverse Events Within 7 Days | 7 days | Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ordinal Distribution of Scores on mRS at Day 90 | 90 days | The overall ordinal distribution of scores on mRS at 90 days in all subjects of two groups will be determined. |
| Ordinal Distribution of Scores on mRS at Day 180 | 180 days | The overall ordinal distribution of scores on mRS at 180 days in all subjects of two groups will be determined. |
| Changes of perihematomal edema volume | 0-7 days after enrollment. | Perihematomal edema volume (ml) is assessed by CT brain scan |
| Changes of intracerebral hematoma volume | 0-7 days after enrollment. | Intracerebral hematoma volume (ml) is assessed by CT brain scan |
Countries
China
Contacts
Primary ContactXunming Ji, MD, PhD
Backup ContactWenbo Zhao, MD, PhD
Outcome results
None listed