The purpose of this study is to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.
Age ≥ 18 years
Supratentorial intracerebral hemorrhage confirmed by brain CT scan
Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
NIHSS score ≥ 4 and GCS ≥ 6 upon presentation
Definite evidence of secondary ICH, such as structural abnormality, brain tumor, thrombolytic drug, and other causes
A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
Already booked for surgical treatment
Life expectancy of less than 90 days due to comorbid conditions
Parallel
Remote ischemic conditioning
Procedure/SurgeryRemote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days.
Sham remote ischemic conditioning
Procedure/SurgerySham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2
The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days.
Frequency of adverse events
The safety endpoints will include all adverse events until day-7 or discharge (whichever is earlier), and severe adverse events through day-90 after the onset of intracerebral hemorrhage.
Proportion of hematoma growth
The proportional growth in hematoma volume during the first 24h after the onset of intracerebral hemorrhage.
Proportion of hematoma absorption
The proportional change in hematoma volume between 24h and 14 days or discharge (whichever is earlier) after the onset of intracerebral hemorrhage.
Changes of hematological indicators
The changes of hematological indicators (inflammatory cytokine,et al.) during the first 24h and 7 days after the onset of intracerebral hemorrhage.
Click on the lead sponsor to view all of their trials.
Yi Yang
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
