Safety of Beta-hCG + Erythropoietin in Acute Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to assess the safety of Beta-hCG + Erythropoietin in patients with acute ischemic stroke.
详细描述
Patients with a new stroke will be evaluated at the University of California Irvine Medical Center (UCIMC), a JCAHO-certified Stroke Center, and at Hoag Memorial Hospital Presbyterian. Standard stroke pathways will be used to identify such patients and to initiate standard of care therapy. Patients potentially eligible for study enrollment will be identified, screened, then consented and enrolled. Those meeting all entry criteria, and no exclusion criteria, will undergo additional baseline testing including brain MRI. A 9-day course of B-E therapy will then begin, always within 48 hours after stroke onset. This therapy will consist of hCG (3 once-daily IM doses at 10,000 IU per dose, one day apart, on days 1, 3 and 5 of study participation), followed by a one day washout period (day 6), followed by Epo (three once-daily i.v. doses at 30,000 IU per dose on days 7, 8, and 9 of study participation). Patients will be examined at several time points during therapy, as well as 6 weeks and 3 months after stroke onset. The primary outcome measures are related to safety, while secondary outcome measures are related to disability, neurological status, and MRI measures.
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NIHSS score 6-24 at time of enrollment, ensuring that stroke is neither mild nor devastating
- •Stroke is ischemic in origin, supratentorial, and radiologically confirmed
- •Patient is 24-48 hours from time of stroke onset at time that first dose of B-E therapy is administered. Time of onset is when symptoms began, and stroke occurred during sleep, time of onset is when patient was last seen to be normal.
- •Reasonable expectation of availability to receive the full 9 day B-E therapy course
- •Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated
排除标准
- •Pre-existing and active major psychiatric or other neurological disease
- •History of significant alcohol or drug abuse in the prior 3 years
- •Serum hemoglobin > 16 g/dL in a male patient or > 14 g/dL in a female patient; or a platelet count > 400,000/mm3 in either a male or female patient
- •Advanced liver, kidney, cardiac, or pulmonary disease; the former will be operationally defined as a serum bilirubin > 4 mg/dL, alkaline phosphatase > 250 U/L, SGOT > 150 U/L, SGPT >150 U/L, or creatinine > 3.5 mg/dL
- •Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years, using a test that reliably detects beta-hCG levels > 25 with normal levels being < 8 IU/L.
- •Contraindication to study participation on the basis of any of the following:
- •Allergy or other contraindication to initiating either beta-hCG or Erythropoietin
- •Known hypersensitivity to mammalian cell-derived products or hypersensitivity to albumin
- •A known diagnosis of prostatic cancer; note that prostate specific antigen will be collected for retrospective assessment of safety, but will not be used to ascertain study eligibility
- •Dysuria of unexplained origin
- •Uncontrolled hypertension, defined in the context of acute stroke as blood pressure persistently above 220 mm Hg systolic or 120 diastolic despite antihypertensive therapy
- •Current use of either beta-hCG or Erythropoietin
- •Other condition known to elevate beta-hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor
- •Terminal medical diagnosis consistent with survival < 1 year
- •Known hypercoagulable state, which for the purposes of this study will deficiency of proteins C, S, or antithrombin III; activated protein C resistance; prothrombin gene mutation; or an anti-phospholipid antibody syndrome as based on clinical and laboratory measures.
研究组 & 干预措施
Dual Growth Factor
All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.
干预措施: Dual Growth Factor (Drug)
结局指标
主要结局
Safety
时间窗: 3 mo
Safety through Day 90 was assessed through adverse event reporting, serial examinations, blood testing, and a leg vein Doppler at Day 42. Number of participants who experienced adverse events, had abnormality in serial examinations, blood testing, and a leg vein Doppler at Day 42.
Morbidity
时间窗: 3 mo
attributable to experimental intervention
Mortality
时间窗: 3 mo
attributable to experimental intervention
次要结局
- Action Research Arm Test(3 mo)
- Fugl-Meyer Arm Scale(3 mo)
- Fugl-Meyer Leg Scale(3 mo.)
- Boston Naming Test(3 mo)
- Line Cancellation Test(3 mo)
- NIH Stroke Scale(3 mo)
- Geriatric Depression Scale Short Form(3 mo)
- Barthel Index(3 mo)
- Infarct Volume Using Anatomical MRI(3 mo)
- Trail Making A Test(3 mo)
- Trail Making B Test(3 mo.)
研究者
Steven C. Cramer, MD
Professor
University of California, Irvine