Remote Ischemic Conditioning for the Treatment of Intracerebral Hemorrhage (RICH-2)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    452
  • sponsor
    Capital Medical University
Updated on 25 July 2022

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.

Details
Condition Intracerebral Hemorrhage, Acute Stroke
Treatment Remote Ischemic conditioning, Sham Remote Ischemic Conditioning, Standard medication therapy
Clinical Study IdentifierNCT04657133
SponsorCapital Medical University
Last Modified on25 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 and ≤ 80 years
The diagnosis of supratentorial ICH is confirmed by brain CT scan
Hematoma volume of 10 to 30 ml and Glasgow Coma Score (GCS)>8 at randomization
National Institutes of Health Stroke Scale (NIHSS)≥6 and ≤20 points at randomization
Randomization and starting treatment between 24 and 48 hours of symptom ictus
Signed and dated informed consent is obtained

Exclusion Criteria

Planned surgical evacuation of ICH prior to administration of investigational intervention
ICH concomitant with subarachnoid hemorrhage or intraventricular hemorrhage
Suspected secondary ICH related to tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis
Patients with a pre-existing neurological deficit (mRS>1) or psychiatric disease that would confound the neurological or functional evaluations
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
Severe renal disease (i.e., renal disorder requiring dialysis ) or eGFR <30ml/min/1.73m2
Severe liver disorder, or ALT >3 times or bilirubin >2 times upper limit of normal
Known severe hearing loss or cognitive impairment
Known pregnancy, or positive pregnancy test, or breastfeeding
Patients known or suspected of not being able to comply with the study protocol due to alcoholism, noncompliance or any other cause
Life expectancy of less than 90 days due to co-morbid conditions
Concurrent participation in another research protocol for investigation of another experimental therapy
Severe, sustained hypertension (Systolic blood pressure> 180 mmHg or diastolic blood pressure> 110 mmHg)
Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs
Any condition which, in the judgement of the investigator, might increase the risk to the patient
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