A Prospective, Trial About Safety and Efficacy of Combined Treatment With Cerebrolysin in Acute Ischemic Hemispheric Stroke Patients Undergoing EndoVascular Treatment (EVT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale (mRS)
研究概览
简要总结
The goal of this clinical trial is investigate the efficacy of a neuro/vascular-protective treatment with the drug Cerebrolysin in patients with acute ischemic stroke. starting immediately after completion of a EVT therapy.
The main question the study aims to answer is: If a 10 days treatment with the neuro/vascularprotective drug Cerebrolysin (30 ml/day as intravenous infusion) is able to increase the overall outcome of EVT therapy? Participants will receive intravenous treatment with Cerebrolysin (30 ml/day) starting immediately after thrombolytic therapy and being continued for 10 consecutive days as one single daily infusion. The modified Rankin Scale (mRS) 90 days after onset of symptoms will be investigated, but also the improvement in other ratings as well as the time course of the improvement.
In addition to the clinical outcome measures the study will assess neuroimaging perfusion CT-Perfusion parameters to evaluate possible direct improvement in microcirculation that might be an additional mechanism of action of cerebrolysin.
CT-Perfusion being done immediately after EVT will provide ability to stratify the data according to non-favorable CT-Perfusion parameters after EVT versus favoravle.
详细描述
9.1. Overall Study Design and Plan-Description
The study will be conducted as a single center, trial. In patients with AIS after EVT, according to the consensus guidelines, the study drug (Cerebrolysin) will be administered as IV-infusion over 30 minutes. First treatment will be administered up to 3 hours after completion of the EVT intervention.. First treatment will be given after a post EVT CT-Perfusion was performed. The treatment with Cerebrolysin will be repeated until day 10 as a single daily infusion. Patients may be inpatients as long as deemed necessary by the principal investigator. The observation period will last 9 (±14) month days after the administration of study medication. Patients recruited but not treated with the study drug due to various reasons or who do not receive the total dose of study medication will also be observed for 9 month if they survive.
The study is planned to be started in October 2023 (first patient in) and should be finished by June 2024.
The study will be conducted at the Shaare Zedek Medical Center. Treatments must be performed by a physician specialized in neurological care.
9.2. Discussion of Study Design, Including the Choice of Control Groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male inpatients.
- •Age: ≥18 years.
- •Clinical diagnosis of ischemic stroke eligible for EVT.
- •No contraindication to undergo CT-Perfusion
- •Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the legally authorised representative or two independent physicians, according to the regulatory and legal requirements of israel.
排除标准
- •Brain Imaging
- •Evidence of intracranial haemorrhage (ICH) on the CT-scan
- •Participation in another therapeutic clinical trial 3 months before baseline
- •Female patient of childbearing age must not be pregnant as proved by Beta-HGB negative testing.
- •Platelet count of below 100x103/mm3
- •Blood glucose <50
- •Known haemorrhagic diathesis
- •Manifest or recent severe or dangerous bleeding
- •Known bacterial endocarditis, pericarditis
- •Acute pancreatitis
- •Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformation
- •Neoplasm with increased bleeding risk
- •Severe liver disease, including hepatic failure, cirrhosis, portal hypertension, oesaphageal varices) and active hepatitis
- •Major surgery or significant trauma in past 3 months
- •Multiple serious drug allergies
- •Hypersensitivity or allergy to one of the components of the drug
- •Severe renal impairment Psychiatric
- •Chronic intoxication or chronic substance use disorder with pharmaceuticals, drugs, alcohol or industrial poisons
- •Neurological
- •Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal
- •Known history of or suspected intracranial haemorrhage
- •Suspected subarachnoid haemorrhage or condition after subarachnoid hemorrhage from aneurysm
- •Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
- •Haemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy)
研究组 & 干预措施
Participants undergo EVT plus Cerebrolysin
one group of patients should receive intravenous treatment with Cerebrolysin (30 ml/day) starting post EVT CT-Perfusion that will be performed not later than 3 hours from completion of EVT. Treatment will be continued for 10 consecutive days as one single daily infusion.
干预措施: Cerebrolysin (Drug)
结局指标
主要结局
Modified Rankin Scale (mRS)
时间窗: 90 Days
Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A standardized interview also exists to try to reduce subjectivity or variability in score assignments. Ranges between 0-6
次要结局
- Glasgow Outcome Score(90 days)
- NIH Stroke Scale (NIHSS)(90 Days)
- Short Form 36 Health Survey (SF36)(90 days)
- Geriatric Depression Scale (GDS)(90 days)
- Montreal Cognitive Assessment (MoCA)(90 days)
研究者
Eichel
Dr. Eichel- Head of the Neurology Department
Shaare Zedek Medical Center