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临床试验/NCT05630534
NCT05630534尚未招募1 期

Study of Minocycline Accelerated Intracerebral Hemorrhage Absorption (MACHA)

Second Affiliated Hospital, School of Medicine, Zhejiang University0 个研究点目标入组 90 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
90
主要终点
Improvement in modified Rankin Scale score at 90 days of onset

研究概览

简要总结

Minocycline has been found to reduce cerebral edema secondary to cerebral hemorrhage, promote hematoma absorption, and shorten hematoma absorption time; clinical studies have been conducted to confirm the safety in the treatment, but no significant hematoma absorption effect was seen with short duration of drug use. Therefore, the investigators propose to conduct a multicenter randomized controlled clinical trial to determine its accelerating effect on hematoma absorption.

详细描述

There is a significant increase in the incidence of spontaneous intracerebral hemorrhage, combined with a high mortality rate. Surgical treatment is mainly used to remove intracerebral hematoma with a supratentorial volume greater than 20ml, and most intracerebral hematomas below 20mL are left to absorb on their own, and the absorption time of such hematomas is about 4 to 6 weeks. Minocycline is a tetracycline antibiotic routinely used in clinical practice for the treatment of bacterial infection and acne.

It has been found that it can not only reduce iron overload after intracerebral hemorrhage and inhibit neuroinflammation, but also reduce secondary cerebral edema. Some animal experiments have confirmed that it can promote hematoma absorption through iron chelation and shorten hematoma absorption time; clinical studies have been conducted to confirm the safety in the treatment of intracerebral hemorrhage, but no significant effect has been seen with short duration of drug use. No clinical RCT study has been conducted to confirm its accelerating effect on the absorption of adult intracerebral hematoma. Therefore, the investigators propose to conduct a multicenter randomized controlled clinical trial to determine its accelerating effect on hematoma absorption, and this study will have important clinical practical value.

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, Care Provider)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-80 years old
  • Spontaneous intracerebral hemorrhage by CT scan
  • Intracerebral hematoma volume is less than 16ml
  • No surgical treatment of hematoma evacuation

排除标准

  • Allergies to tetracycline antibiotics
  • Pregnancy or suspected pregnancy (pregnancy test will be done on women with fertility potential)
  • Hepatic and/or renal insufficiency
  • Glasgow Coma Scale of 5 or less
  • Secondary cerebral hemorrhage caused by trauma, arteriovenous malformation, aneurysm, tumor or other reasons
  • Thrombocytopenia (platelet count<75000/mm3) or coagulation dysfunction (INR>1.4)
  • Incapable to take care of themselves in past life (score of Rankin scale before stroke>2)
  • Signed DNR (Do Not Resuscitate)

研究组 & 干预措施

Minocycline

Experimental

This intervention arm will receive oral or intranasal minocycline capsules 100 mg Q12H, first dose 200 mg, start on the fifth day of cerebral hemorrhage, for 14 days

干预措施: Minocycline (Drug)

Control(starch)

Placebo Comparator

This arm will receive oral or intranasal administration of identically packaged placebo capsules (starch) 100 mg Q12H, first dose 200 mg, start on the fifth day of cerebral hemorrhage, for 14 days

干预措施: starch (Other)

结局指标

主要结局

Improvement in modified Rankin Scale score at 90 days of onset

时间窗: 90 days

modified Rankin Scale score (points ranging from 0 to 6)

次要结局

  • Number adverse events related to minocycline within 90 days(90 days)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

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