CTRI/2024/03/064429进行中（未招募）不适用
Spontaneous intracerebral hemorrhage - outcomes of different surgical approaches
Kasturba Hospital, Manipal1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年4月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Primary outcomes are mRS modified Rankin Scale at 3 months follow up and Effective hematoma evacuation or residual hematoma volume
研究概览
简要总结
Through this study, we aim to understand the differences and impact of microsurgical, endoscopic evacuation and decompressive craniectomy for spontaneous intracranial hemorrhage (SIH) as carried out in our local setting. This study hopes to identify the better surgical technique for SIH and also the effectiveness of the minimally invasive surgeries like endoscopic and microsurgical techniques in management of SIH.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between 18 to 70 years.
- •Informed consent for surgery is given by patient or their family.
- •GCS 5 or more.
- •Hematoma volume greater than 30 ml.
排除标准
- •Patients or family not giving consent for surgery.
- •Traumatic ICH .
- •Pregnant patients .
- •Age less than 18 years or greater than 70 years.
- •Patients not on regular follow up.
- •GCS on arrival E1M1V1 with absent brainstem reflexes.
- •If prior or present history of an intracranial tumor, aneurysm or vascular pathology, or stroke and or status post chemotherapy or radiotherapy.
- •Hematoma involving the posterior fossa or brainstem or midbrain.
- •Those patients with SIH that didn’t warrant surgery as per the senior consultants decision.
- •Those patients undergoing medical management.
- •If CT scan at the time of presentation shows completely effaced basal cisterns, advanced herniation and midline shift greater than 1cm.
结局指标
主要结局
Primary outcomes are mRS modified Rankin Scale at 3 months follow up and Effective hematoma evacuation or residual hematoma volume
时间窗: mRS will be evaluated at 3 months post discharge.
次要结局
- Secondary outcomes are Complications rebleed, meningitis, postoperative new deficits. ICU stay in days. Hospital stay in days. Tracheostomy, if done. If on oral feeds at time of discharge. Late neurological deterioration & Perioperative mortality(mRS will be evaluated at 3 months post discharge.)
研究者
Geeta S
Department of Neurosurgery, KMC, Manipal, MAHE University
研究点 (1)
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