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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
452
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.
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.
Standard medication therapy will be performed according to the national and international guidelines.
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
ACTIVE_NOT_RECRUITINGBeijing Red Cross Emergency Rescue Center
Beijing, Beijing Municipality, China
ACTIVE_NOT_RECRUITINGBeijing Renhe Hospital
Beijing, Beijng, China
NOT_YET_RECRUITINGChengde Central Hospital
Chengde, Hebei, China
RECRUITINGThe Six People's Hospital of Hengshui
Hengshui, Hebei, China
RECRUITINGNanshi Hospital of Nanyang
Nanyang, Henan, China
RECRUITINGTongliao Municipal Hosptial
Tongliao, Inner Mongolia, China
NOT_YET_RECRUITINGThe First People's Hospital of Changzhou
Changzhou, Jiangsu, China
RECRUITINGThe Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGTianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
RECRUITING...and 3 more locations
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 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.
Time frame: 0-90 days.
Proportion of Patients With mRS Score 0-3 at 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.
Time frame: 90 days
Proportion of Patients With mRS Score 0-2 at 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.
Time frame: 180 days
Proportion of Patients With mRS Score 0-3 at 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.
Time frame: 180 days
Number of Subjects Experiencing Serious Adverse Events
Number of subjects experiencing Serious adverse events at any time from randomization through day 90
Time frame: 90 days
Number of Subjects With Serious Adverse Events Within 7 Days
Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization
Time frame: 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.