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临床试验/NCT04426487
NCT04426487Unknown早期 1 期

Effect of Progesterone Therapy in Cases With Traumatic Subarachinoid Haemorrhage on Clinical Outcome and Resistive Vasculer Indices of Middle Cerebral Artery Transcranial Doppler

Minia University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年6月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
200
试验地点
1
主要终点
Number of participants suffering neuronal infarction

研究概览

简要总结

Traumatic subarachinoid hemorrhage is associated with serious complications related to mortality . Delayed neuronal ischemia and rebleeding are most common and serious. Progesterone can delay both .

详细描述

Progesterone is an neurosteroid that can help integrity of blood brain barrier . Traumatic subarachinoid hemorrhage disrupts this blood brain barrier facilitating post traumatic vasospasm and neuronal ischemia. Transcranial doppler can detect cerebral vasoconstriction through resistive vasculer indices

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
Single (Care Provider)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Traumatic subarachinoid hemorrhage

排除标准

  • History of malignency
  • History of cerebrovasculer stroke
  • Morbid obese

研究组 & 干预措施

Control

Placebo Comparator

Receiving conventional management for traumatic subarachinoid hemorrhage

干预措施: Progesterone (Drug)

progesterone group

Active Comparator

Intramusculer progesterone therapy before and after craniotomy

干预措施: Progesterone (Drug)

结局指标

主要结局

Number of participants suffering neuronal infarction

时间窗: 2 months

Transcranial doppler

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mina Maher

Principle investigator

Ministry of Health and Population, Egypt

研究点 (1)

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