Remote Ischemic Conditioning for Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

— RICH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930940
• Other study ID #: RICH
• Status: Completed
• Phase: Phase 1
• Start date: July 9, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: February 2020
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 10, 2020
• Est. primary completion date: November 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age=18 and =80.

2. The diagnosis of ICH is confirmed by brain CT scan.

3. Hematoma volume of 10 to 30 ml.

4. Glasgow Coma Score (GCS)>8.

5. Starting RIC treatment between 24 and 48 hours of ictus.

6. Signed and dated informed consented is obtained.

Exclusion Criteria:

1. Patients with suspected secondary ICH related to tumor, coagulopathy, ruptured aneurysm or arteriovenous malformation, or venous sinus thrombosis.

2. ICH concomitant with subarachnoid hemorrhage or intraventricular hemorrhage. Planned surgical evacuation of hematoma prior to RIC.

3. Evidence of significant shift of midline brain structure (> 10 mm) or herniation on brain imaging.

4. Known pregnancy (or positive pregnancy test), or breast-feeding.

5. Concurrent participation in another research protocol for investigation of another experimental therapy.

6. Patients with a pre-existing neurological deficits (modified Ranks scale score >1) or psychiatric disease that would confound the neurological or functional evaluations.

7. Life expectancy of less than 90 days due to co-morbid conditions.

8. Severe hepatic and renal dysfunction.

9. Severe, sustained hypertension (SBP > 180 mmHg or DBP > 110 mmHg).

10. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.

11. Any condition which, in the judgment of the investigator, might increase the risk to the patient.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Device:
• remote ischemic conditioning
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.

Other:
• Regular treatment
Regular treatment is based on associated guidelines for ICH.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Capital Medical University	Heze Municipal Hospital, The Sixth People's Hosptial of Hengshui, Weihai Municipal Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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:CD012503. doi: 10.1002/14651858.CD012503.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety]		7 days.