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NCT03930940: RICH

Remote Ischemic Conditioning for Intracerebral Hemorrhage

Completed Phase 1 Last updated 11 February 2020
What this trial tests

Phase 1 trial testing remote ischemic conditioning in Intracerebral Hemorrhage in 40 participants. Completed in 10 February 2020.

Timeline
9 July 2019
Primary endpoint
17 November 2019
10 February 2020

Quick facts

Lead sponsorCapital Medical University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment40
Start date9 July 2019
Primary completion17 November 2019
Estimated completion10 February 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Capital Medical University

Who can join

Adults 18 to 80, any sex, with Intracerebral Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Safety and efficacy of remote ischemic conditioning for the treatment of intracerebral hemorrhage: A proof-of-concept randomized controlled trial.
    Zhao W, Jiang F, Li S, Liu G, et al · · 2022 · cited 21× · PMID 33739197 · DOI 10.1177/17474930211006580
  2. Erythrophagocytosis by Microglia/Macrophage in Intracerebral Hemorrhage: From Mechanisms to Translation.
    Liu J, Zhu Z, Leung GK. · · 2022 · cited 19× · PMID 35237132 · DOI 10.3389/fncel.2022.818602
  3. Remote Ischemic Conditioning for Intracerebral Hemorrhage (RICH-1): Rationale and Study Protocol for a Pilot Open-Label Randomized Controlled Trial.
    Zhao W, Jiang F, Li S, Wu C, et al · · 2020 · cited 15× · PMID 32411082 · DOI 10.3389/fneur.2020.00313
  4. New targets in spontaneous intracerebral hemorrhage.
    Chiang PT, Tsai LK, Tsai HH. · · 2025 · cited 12× · PMID 39325041 · DOI 10.1097/wco.0000000000001325
  5. Dabigatran etexilate versus warfarin in cerebral venous thrombosis in Chinese patients (CHOICE-CVT): An open-label, randomized controlled trial.
    Ma H, Gu Y, Bian T, Song H, et al · · 2024 · cited 12× · PMID 38353219 · DOI 10.1177/17474930241234749
  6. Conditioning medicine for ischemic and hemorrhagic stroke.
    Hess DC, Khan MB, Kamat P, Vaibhav K, et al · · 2021 · cited 6× · PMID 34414362
  7. Pilot Study of Remote Ischemic Conditioning in Acute Spontaneous Intracerebral Hemorrhage.
    Jarrahi A, Shah M, Ahluwalia M, Khodadadi H, et al · · 2022 · cited 4× · PMID 35645722 · DOI 10.3389/fnins.2022.791035

Verify or expand the search:

Other trials of remote ischemic conditioning

Trials testing the same drug.

Other recruiting trials for Intracerebral Hemorrhage

Currently open trials in the same condition.

Other Capital Medical University trials

Trials by the same sponsor.

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