A Phase 1 interventional study of remote ischemic conditioning and Regular treatment in Intracerebral Hemorrhage, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Capital Medical University · Phase 1, Interventional, and Treatment
Spontaneous intracerebral hemorrhage (ICH) results from the rupture of small vessels damaged by chronic hypertension, amyloid angiopathy or other disease. Hematoma volume has been demonstrated to be strongly correlated with the severity of white matter injury and conditions in ICH patients. In the past decades, surgical clot evacuation and stereotactic or endoscopic clot aspiration with thrombolytic drugs have been investigated for the treatment of ICH, however, none of them have been demonstrated to be effective. As such, medical management remains the standard of care for most patients with ICH, leading to ICH as the least treatable form of stroke.
Remote ischemic conditioning (RIC) 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. Therefore, the investigators plan to undertake this study to evaluate the safety of RIC in patients with ICH, and planned for future study to determine if treatment with RIC can improve the outcome of patients with ICH.
In this study, our main objectives are: 1) to evaluated the safety of RIC, by determining the treatment related adverse events, in patients with ICH; and 2) to determine the preliminary effects of RIC on hematoma absorption and cerebral edema.
The investigators hypothesize that RIC is well-tolerated and has minimal serious adverse effects in patients with ICH; and 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.
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
RIC treatment and regular treatment.
Device: remote ischemic conditioning · Other: Regular treatment
Regular treatment alone.
Other: Regular treatment
RIC is a non-invasive therapy that performed by an electric autocontrol device with cuffs placed on arm and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 4 to 5 times.
Regular treatment is based on associated guidelines for ICH.
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: 7 days.
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Capital Medical University