Remote Ischemic Preconditioning (RIPC) and Aneurysmal Subarachnoid Hemorrhage (SAH)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 主要终点
- Neurological Functional Outcome at 3 Months (mRS)
研究概览
简要总结
Aneurysmal subarachnoid hemorrhage (SAH) is a severe form of stroke caused by bleeding around the brain. Despite early treatment of the initial hemorrhage, many patients develop delayed cerebral ischemia several days later, which is a major cause of neurological disability, cognitive impairment, and mortality. Current preventive and therapeutic strategies are only partially effective, highlighting the need for new treatment approaches.
This study investigates a simple, non-invasive technique called remote ischemic preconditioning (RIPC). RIPC consists of brief, repeated cycles of limb ischemia and reperfusion induced by a blood pressure cuff. RIPC is thought to activate endogenous protective mechanisms that may improve the brain's tolerance to ischemia. Although beneficial effects have been reported in experimental models and cardiovascular diseases, its clinical efficacy in aneurysmal SAH remains uncertain.
In this randomized, controlled, single-blinded, multicenter study, adult patients admitted with aneyrysmal SAH will be randomly assigned to receive RIPC or a sham procedure. The RIPC group will undergo cycles of brief lower-limb ischemia using a pressure cuff, while the sham group will receive an identical procedure without inducing ischemia. Patients and neurologists assessing outcomes will remain blinded to group allocation.
The intervention will be performed every two days from day 2 to day 10 after hemorrhage. Neurological outcome will be assessed at 3 months using the modified Rankin Scale. Secondary outcomes include mortality at 3 months, long-term neurological and cognitive function outcomes at 12 months, and the incidence of adverse events related to the procedure.
If effective, RIPC could become a simple, low-cost, widely accessible method to reduce disability after SAH. The results may help improve future treatment strategies for this severe condition.
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, Outcomes Assessor)
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
- •Age over 18 years
- •Hospitalization for aneurysmal subarachnoid hemorrhage confirmed by CT scan and/or lumbar puncture
- •Confirmation of intracranial aneurysm by CT angiography and/or cerebral angiography
- •Written informed consent obtained from the patient or legal representative
- •Affiliation to a social security system
排除标准
- •Skin, orthopedic, or vascular conditions of the limbs contraindicating ischemic preconditioning (e.g., ulcers, fractures, deep vein thrombosis)
- •Pregnancy
- •Withdrawal of informed consent
研究组 & 干预措施
Ischemic Preconditioning (RIPC)
干预措施: Remote Ischemic Preconditioning (Procedure)
Sham Procedure
干预措施: Sham Ischemic Preconditioning (Procedure)
结局指标
主要结局
Neurological Functional Outcome at 3 Months (mRS)
时间窗: 3 months (+/- 15 days) post-aneurysmal subarachnoid hemorrhage
Assessment of neurological disability and dependency using the modified Rankin Scale (mRS) performed by a blinded neurologist. The mRS is a 6-point scale (0 to 5), with 5 being a severe disability.
次要结局
- Safety Outcomes(From day 0 until 12 months post-aneurysmal subarachnoid hemorrhage.)
- Evaluation of mortality at 3 Months(From day 0 to 3 months post-hemorrhage)
- Long-term Neurological Outcome at 12 Months (mRS)(12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage)
- Evaluation of Cognitive Function at 12 months (MMSE)(12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage)
- Evaluation of Cognitive Function at 12 months (MoCA)(12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage)
