Remote Ischemic Conditioning for Intracerebral Hemorrhage

NCT03930940 | Completed Phase 1 DMC

• 1 other identifier: RICH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracerebral Hemorrhage

Keywords

Spontenous intracerebral hemorrhage; Hemorrhage resolution; Remote ischemic conditioning; Neuroprotection

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety]

  7 days.

Study Arms (2)

RIC group

EXPERIMENTAL

RIC treatment and regular treatment.

Device: remote ischemic conditioning; Other: Regular treatment

Control group

OTHER

Regular treatment alone.

Other: Regular treatment

Interventions

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.

RIC group

Regular treatment OTHER

Regular treatment is based on associated guidelines for ICH.

Control group; RIC group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead
• Heze Municipal Hospital: collaborator
• The Sixth People's Hosptial of Hengshui: collaborator
• Weihai Municipal Hospital: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

Related Publications (8)

• Vaibhav K, Braun M, Khan MB, Fatima S, Saad N, Shankar A, Khan ZT, Harris RBS, Yang Q, Huo Y, Arbab AS, Giri S, Alleyne CH Jr, Vender JR, Hess DC, Baban B, Hoda MN, Dhandapani KM. Remote ischemic post-conditioning promotes hematoma resolution via AMPK-dependent immune regulation. J Exp Med. 2018 Oct 1;215(10):2636-2654. doi: 10.1084/jem.20171905. Epub 2018 Sep 6.

  PMID: 30190288 BACKGROUND

• Zhao W, Meng R, Ma C, Hou B, Jiao L, Zhu F, Wu W, Shi J, Duan Y, Zhang R, Zhang J, Sun Y, Zhang H, Ling F, Wang Y, Feng W, Ding Y, Ovbiagele B, Ji X. Safety and Efficacy of Remote Ischemic Preconditioning in Patients With Severe Carotid Artery Stenosis Before Carotid Artery Stenting: A Proof-of-Concept, Randomized Controlled Trial. Circulation. 2017 Apr 4;135(14):1325-1335. doi: 10.1161/CIRCULATIONAHA.116.024807. Epub 2017 Feb 7.

  PMID: 28174194 BACKGROUND

• Zhao W, Zhang J, Sadowsky MG, Meng R, Ding Y, Ji X. Remote ischaemic conditioning for preventing and treating ischaemic stroke. Cochrane Database Syst Rev. 2018 Jul 5;7(7):CD012503. doi: 10.1002/14651858.CD012503.pub2.

  PMID: 29974450 BACKGROUND

• Zhao W, Che R, Li S, Ren C, Li C, Wu C, Lu H, Chen J, Duan J, Meng R, Ji X. Remote ischemic conditioning for acute stroke patients treated with thrombectomy. Ann Clin Transl Neurol. 2018 Jun 6;5(7):850-856. doi: 10.1002/acn3.588. eCollection 2018 Jul.

  PMID: 30009202 BACKGROUND

• Zhao W, Li S, Ren C, Meng R, Jin K, Ji X. Remote ischemic conditioning for stroke: clinical data, challenges, and future directions. Ann Clin Transl Neurol. 2018 Nov 15;6(1):186-196. doi: 10.1002/acn3.691. eCollection 2019 Jan.

  PMID: 30656197 BACKGROUND

• Ma H, Gu Y, Bian T, Song H, Liu Z, Ji X, Duan J. Dabigatran etexilate versus warfarin in cerebral venous thrombosis in Chinese patients (CHOICE-CVT): An open-label, randomized controlled trial. Int J Stroke. 2024 Jul;19(6):635-644. doi: 10.1177/17474930241234749. Epub 2024 Feb 26.

  PMID: 38353219 DERIVED

• Zhao W, Jiang F, Li S, Liu G, Wu C, Wang Y, Ren C, Zhang J, Gu F, Zhang Q, Gao X, Gao Z, Song H, Ma Q, Ding Y, Ji X; RICH-1 Investigators. Safety and efficacy of remote ischemic conditioning for the treatment of intracerebral hemorrhage: A proof-of-concept randomized controlled trial. Int J Stroke. 2022 Apr;17(4):425-433. doi: 10.1177/17474930211006580. Epub 2021 Apr 7.

  PMID: 33739197 DERIVED

• Zhao W, Jiang F, Li S, Wu C, Gu F, Zhang Q, Gao X, Gao Z, Song H, Wang Y, Ji X; RICH-1 Investigators. Remote Ischemic Conditioning for Intracerebral Hemorrhage (RICH-1): Rationale and Study Protocol for a Pilot Open-Label Randomized Controlled Trial. Front Neurol. 2020 Apr 28;11:313. doi: 10.3389/fneur.2020.00313. eCollection 2020.

  PMID: 32411082 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Xunming Ji, MD, PhD

  Xuanwu Hospital, Capital Medical Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2019
• First Posted: April 29, 2019
• Study Start: July 9, 2019
• Primary Completion: November 17, 2019
• Study Completion: February 10, 2020
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)