Cerebral amyloid angiopathy-related intracerebral (CAAH) hemorrhage is second factor of primary intracerebral hemorrhage. However, no effective prevention and treatment strategies have been established. Remote ischemic conditioning is a neuroprotective strategy. In animal studies,RIC is efficiency in accelerating the absorption of hematoma. Therefore, the investigators plan to carry out this research to evaluate the safety and efficacy of RIC in patients with CAA related ICH.
In China, primary intracerebral hemorrhage accounts for 80-85% of all types of intracerebral hemorrhage, while cerebral amyloid angiopathy-related intracerebral hemorrhage is the second factor, accounting for approximately 20-30%. It is often characterized by repeated and multifocal lobar hemorrhage, which will not only cause neurological deficit on the limbs, but also influence the cognitive level of patients and may even be life-threatening. At present, the role of surgery in CAA-related ICH is controversial, and there is no effective prevention and treatment strategies have been established. Additionally, it is always associated with a low rate of good prognosis(11%-60%) and a high risk of recurrent ICH (10%-60%). Thus, a novel approach which can improve the clinical outcome and reduce the risk of recurrent intracerebral hemorrhage is urgently needed. Remote ischemic conditioning (RIC) has been developed as a neuroprotective strategy to prevent and treat acute ischemic stroke and small cerebrovascular disease. Additionally, clinical research testified that RIC is safe and feasible for patients with subarachnoid hemorrhage. In animal studies, RIC is efficiency in accelerating the absorption of hematoma. Therefore, the investigators plan to carry out this research to evaluate the safety and efficacy of RIC in patients with CAA related ICH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
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 10-14 days after enrollment.
Xuan Wu Hospital,Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGIncidence of treatment-emergent adverse events
Safety
Time frame: 90±7 days
Changes of intracerebral hematoma volume
Intracerebral hematoma volume (ml) is assessed by CT brain scan.
Time frame: 14± 2 days
Changes of perihematomal edema volume
Perihematomal edema volume (ml) is assessed by CT brain scan.
Time frame: 14± 2 days
Incidence rate of the perihematomal edema expansion
The enlargement of perihematomal edema volume (ml) is assessed by CT brain scan.
Time frame: 14± 2 days
Shift of midline brain structure
Shift of midline brain structure (mm) is assessed by CT brain scan
Time frame: 14± 2 days
Prognosis of function outcome at 90 Days
accessed by modified Rankin score
Time frame: 90±7 days
Prognosis of neurological function at 90 Days
The Barthel index will be assessed at follow-up.
Time frame: 90±7 days
Changes of serum biomarker of blood brain barrier (Matrix metalloproteinases,MMPs)
The biomarker of blood brain barrier(MMPs) are assemented by the same laboratory.
Time frame: 7± 2 days
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Changes of serum biomarker of inflammatory ( interleukin)
The interleukin will be assemented by the same laboratory.
Time frame: 7± 2 days
Other adverse events related to RIC treatment
Other adverse events related to RIC treatment,such as mucocutaneous hemorrhage,changes in coagulation function and so on.
Time frame: 90±7 days