Clinical Trial: The Adult Hemorrhagic Moyamoya Surgery Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: The Adult Hemorrhagic Moyamoya Surgery Study

Brief Summary: The aim of this study is to investigate whether extracranial-intracranial(EC-IC) bypass surgery could prevent rebleeding and improve neurological function in adult moyamoya with hemorrhagic onset.

Detailed Summary:

About one half of adult moyamoya patients present with hemorrhagic onset.As the bleeding events are potentially fatal, it often lead to particularly poor prognosis.However, the natural history is still poorly understood.Although the rebleeding rate is known to be extremely high,no effective therapeutic method has been established based on a worldwide consensus.

The recently published Japanese Adult Moyamoya(JAM) Trial, which is the first prospective,randomized,controlled trial focused on hemorrhagic moyamoya,showed that direct bypass surgery could reduce the rebleeding rate and improve the prognosis.However,the result was statistically marginal with a small sample size and most importantly,it failed to assess the neurological function.The effect of bypass surgery on functional outcome was uncertain.

Therefore,the AHMSS study in China is designed to compare the efficacy and safety of EC-IC bypass surgery with conservative treatment in adult moyamoya patients with hemorrhagic onset by comprehensive assessment of rebleeding rate, neurological function.


Sponsor: Huashan Hospital

Current Primary Outcome: All strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards [ Time Frame: within 5 years of randomization ]

The number of participants who suffer from all strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards within 5 years of randomization


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • All kinds of adverse events related to surgery [ Time Frame: up to 30 days ]
    The number of participants who suffer from all kinds of adverse events related to surgery within 30 days
  • Rebleeding on the contralateral side [ Time Frame: up to 5 years ]
    The number of participants who suffer from rebleeding on the contralateral side within 5 years of randomization
  • Transient ischemic attack on the surgically treated side [ Time Frame: up to 5 years ]
    The number of participants who suffer from TIA on the surgically treated side within 5 years of randomization
  • The changes from baseline in modified Rankin Scale (mRS) [ Time Frame: at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial ]
    The changes from baseline in modified Rankin Scale (mRS) at 7 days, 30 days, 6 months, 12 months, 24 months，36 months，60 months or end of trial
  • The changes from baseline in National Institute of Health Stroke Scale (NIHSS) [ Time Frame: at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial ]
    The changes from baseline in National Institute of Health Stroke Scale (NIHSS) at 7 days, 30 days, 6 months, 12 months, 24 months，36 months，60 months or end of trial
  • The changes from baseline in modified Barthel Index [ Time Frame: at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial ]
    The changes from baseline in modified Barthel Index at 7 days, 30 days, 6 months, 12 months, 24 months，36 months，60 months or end of trial


Original Secondary Outcome: Same as current

Information By: Huashan Hospital

Dates:
Date Received: November 28, 2014
Date Started: May 2015
Date Completion: May 2023
Last Updated: February 13, 2016
Last Verified: February 2016