An International Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Progesterone Combined Intranasal and Intramuscular Administration in Patients With Acute Hemorrhagic Stroke
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 184
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
A large number of preclinical studies have confirmed that progesterone and its metabolites have strong neuroprotective effects. As a neuroprotective agent, progesterone has been effective in several animal models of nerve injury, suggesting that the drug has a wide range of neuroprotective effects. Pharmacodynamic studies have shown that some characteristic mechanisms of the action of the neurosteroid on brain injury and cerebral congestion include: prevention of inflammatory reaction and cell death (by inhibiting the activation of inflammatory cytokines and microglia); control of angiogenic brain edema (by reestablishing blood-brain barrier and regulating aquaporin-4 water transporter) and cytotoxic edema (by regulating Progesterone can also improve the neural dysfunction after cerebral hemorrhage, promote the regeneration and repair of damaged axons (activate PI3K / Akt pathway to inhibit the expression of RhoA), prevent the loss of Ca2 + caused by excitotoxicity and improve the survival rate of neurons. It was found that progesterone injection could reduce brain edema and promote the recovery of nerve function after brain injury.
详细描述
The purpose of this clinical trial is to further evaluate the safety and effectiveness of progesterone in the clinical application of major cerebral congestion diseases. The Second Affiliated Hospital of Zhejiang University is the unit in charge of clinical research, and six units participate in the multicenter randomized, double-blind, placebo-controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute hemorrhagic stroke was confirmed by CT or MRI. There should be no obvious sequelae symptoms in the first stroke or previous stroke, Mrs < 2 (slight or no neurological dysfunction).
- •Patients aged 40-80 (male, menopausal women);
- •Patients with 6-48 hours of onset;
- •3 points ≤ NIHSS score ≤ 15 points for light and medium patients;
- •Patients or family members sign informed consent.
排除标准
- •Cerebral CT has excluded intracranial hemorrhage, and there is no imaging change of early large area cerebral infarction.
- •Pregnant or lactating women;
- •Previous intracranial hemorrhage, including suspected subarachnoid hemorrhage; large area stroke (> 2 / 3 MCA territory) or head CT showed any degree of midline displacement due to brain edema. Signs of intracranial hemorrhage (ICH, SAH, extradural hemorrhage, acute or chronic SDH) were found on baseline CT or MRI scan.
- •Fever, defined as central body temperature > 37.5 ℃;
- •Patients with severe heart, liver and kidney dysfunction or severe diabetes;
- •Platelet count was less than 100 × 109 / L, blood glucose was less than 27 mmol / L, serum creatinine was more than 2.0 mg / dL or 180 μ mol / L.
- •Blood pressure: systolic pressure > 180 mmHg, or diastolic pressure > 100 mmHg;
- •Those who have previous allergic history to progesterone and citicoline;
- •The anticoagulant has been taken orally, and INR is more than 15; heparin has been taken within 48 hours (APTT is beyond the normal range);
- •Participating in clinical trials of any other treatment;
- •Patients considered by the researchers not suitable for inclusion.
研究组 & 干预措施
experimental group
Progesterone
干预措施: Progesterone (Drug)
control grou
saline
干预措施: saline (Other)
结局指标
主要结局
Modified Rankin Scale
时间窗: 3 month
The percentage of patients with Mrs score 0, 1 and 2 was compared.
次要结局
未报告次要终点