Remote Ischemic Conditioning for the Treatment of Intracerebral Hemorrhage

Phase 3

• Conditions: Intracerebral Hemorrhage; Acute Stroke
• Interventions: Device: Remote ischemic conditioning; Device: Sham remote ischemic conditioning; Drug: Standard medication therapy

• Registration Number: NCT04657133
• Lead Sponsor: Capital Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-08
• Study Start: 2021-04-22
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-16
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 452

Inclusion Criteria

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

Exclusion Criteria

1. Planned surgical evacuation of ICH prior to administration of investigational intervention
2. ICH concomitant with subarachnoid hemorrhage or intraventricular hemorrhage
3. Suspected secondary ICH related to tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis
4. Patients with a pre-existing neurological deficit (mRS>1) or psychiatric disease that would confound the neurological or functional evaluations.
5. 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
6. Severe renal disease (i.e., renal disorder requiring dialysis ) or eGFR <30ml/min/1.73m2
7. Severe liver disorder, or ALT >3 times or bilirubin >2 times upper limit of normal
8. Known severe hearing loss or cognitive impairment
9. Known pregnancy, or positive pregnancy test, or breastfeeding
10. Patients known or suspected of not being able to comply with the study protocol due to alcoholism, noncompliance or any other cause
11. Life expectancy of less than 90 days due to co-morbid conditions
12. Concurrent participation in another research protocol for investigation of another experimental therapy
13. Severe, sustained hypertension (Systolic blood pressure> 180 mmHg or diastolic blood pressure> 110 mmHg).
14. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
15. Any condition which, in the judgement of the investigator, might increase the risk to the patient.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Remote ischemic conditioning	Subjects in the intervention group will receive remote ischemic conditioning and standard background medical treatment.
Sham group	Sham remote ischemic conditioning	Subjects in the placebo group will receive sham remote ischemic conditioning and standard background medical treatment alone.
Intervention group	Standard medication therapy	Subjects in the intervention group will receive remote ischemic conditioning and standard background medical treatment.
Sham group	Standard medication therapy	Subjects in the placebo group will receive sham remote ischemic conditioning and standard background medical treatment alone.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days	0-90 days.	The mRS ranges from 0 to 6, with higher scores indicating worse outcome. The primary outcome measure is the mRS score, dichotomized to define favorable functional outcome as mRS 0-2 at 90 days.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Serious Adverse Events Within 7 Days	7 days	Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization
Proportion of Patients With mRS Score 0-3 at 90 Days	90 days	The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Another measure of efficacy is the mRS score, dichotomized to define good functional outcome as mRS 0-3 at 90 days.
Proportion of Patients With mRS Score 0-2 at 180 Days	180 days	The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Another measure of efficacy is the mRS score, dichotomized to define good functional outcome as mRS 0-2 at 180 days.
Proportion of Patients With mRS Score 0-3 at 180 Days	180 days	The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Another measure of efficacy is the mRS score, dichotomized to define good functional outcome as mRS 0-3 at 180 days.
Number of Subjects Experiencing Serious Adverse Events	90 days	Number of subjects experiencing Serious adverse events at any time from randomization through day 90

Trial Locations

Locations (13)

Chengde Central Hospital; 🇨🇳 Chengde, Hebei, China

The Six People's Hospital of Hengshui; 🇨🇳 Hengshui, Hebei, China

Nanshi Hospital of Nanyang; 🇨🇳 Nanyang, Henan, China

Tongliao Municipal Hosptial; 🇨🇳 Tongliao, Inner Mongolia Autonomous Region, China

Beijing Renhe Hospital; 🇨🇳 Beijing, Beijng, China

Shaoxing People's Hospital; 🇨🇳 Shaoxing, Zhejiang, China

Zhuji People's Hospital of Zhejaing Province; 🇨🇳 Zhuji, Zhejiang, China

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Red Cross Emergency Rescue Center; 🇨🇳 Beijing, Beijing, China

Tianjin Huanhu Hospital; 🇨🇳 Tianjin, Tianjin, China

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China

Jiaxing Second Hospital; 🇨🇳 Jiaxing, Zhejiang, China

The First People's Hospital of Changzhou; 🇨🇳 Changzhou, Jiangsu, China