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NCT Number: NCT03930940

Remote Ischemic Conditioning for Intracerebral Hemorrhage

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.

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥18 and ≤80.
  • The diagnosis of ICH is confirmed by brain CT scan.
  • Hematoma volume of 10 to 30 ml.
  • Glasgow Coma Score (GCS)>8.
  • Starting RIC treatment between 24 and 48 hours of ictus.
  • Signed and dated informed consented is obtained.

Exclusion criteria

  • Patients with suspected secondary ICH related to tumor, coagulopathy, ruptured aneurysm or arteriovenous malformation, or venous sinus thrombosis.
  • ICH concomitant with subarachnoid hemorrhage or intraventricular hemorrhage. Planned surgical evacuation of hematoma prior to RIC.
  • Evidence of significant shift of midline brain structure (> 10 mm) or herniation on brain imaging.
  • Known pregnancy (or positive pregnancy test), or breast-feeding.
  • Concurrent participation in another research protocol for investigation of another experimental therapy.
  • Patients with a pre-existing neurological deficits (modified Ranks scale score >1) or psychiatric disease that would confound the neurological or functional evaluations.
  • Life expectancy of less than 90 days due to co-morbid conditions.
  • Severe hepatic and renal dysfunction.
  • Severe, sustained hypertension (SBP > 180 mmHg or DBP > 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 judgment of the investigator, might increase the risk to the patient.

Treatment and study plan

remote ischemic conditioning

Device

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

Other

Regular treatment is based on associated guidelines for ICH.

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety]

    Time frame: 7 days.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • Heze Municipal Hospital
  • The Sixth People's Hosptial of Hengshui
  • Weihai Municipal Hospital

Registry information

Official study title

Safey and Efficacy of Remote Ischemic Conditioning in Patient With Spontaneous Intracerebral Hemorrhage

Acronym: RICH

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 29, 2019
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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