Subarachnoid Hemorrhage, AneurysmalNATIONAL-2NCT03153748
New Therapeutic System of Ruptured Intracranial Aneurysms Based on Big Data From Chinese Population
An observational study of Subarachnoid Hemorrhage, Aneurysmal, run by Changhai Hospital at 1 site in China.
Trial summary
This study aims at clarifying the current situation of Emergency treatment of aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the safety and efficacy of the treatment strategy between interventional treatment and open surgery, so as to improve the diagnosis and treatment of aneurysmal SAH. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2016to 31 Dec 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients presented with subarachnoid hemorrhage and diagnosed with ruptured aneurysm at all age.
Who may be able to join
- patients presented with subarachnoid hemorrhage on CT or lumbar puncture.
- the intracranial hemorrhage was caused by rupture of aneurysm and was confirmed on CTA、MRA or DSA.
- patients willing to participate in this clinical trial and attach to regular follow up.
Who cannot join
- intracranial aneurysm correlating to AVM.
- dissection, false, traumatic and infectious aneurysms.
- the rupture of the aneurysm can not be confirmed on CTA、MRA or DSA.
- patients unwilling to participate in this clinical trial and attach to regular follow up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Pengfei Yang, MD, +86 15921196312, 15921196312@me.com
About this study
This study aims at clarifying the current situation of Emergency treatment of aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the safety and efficacy of the treatment strategy between interventional treatment and open surgery, so as to improve the diagnosis and treatment of aneurysmal SAH.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- Treatment strategy
- Medical subject headings
- Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS score
the mRS score after treatment
Measured: 1 year after treatment
cure rate
the proportion of the cured-patient according Raymond Class
Measured: 6 months after treatment
Secondary outcomes (2)
recurrence rate
the proportion of the recurrence of the patient
Measured: through study completion, an average of 1 year
complication rate
the proportion of complication happened after treatment including ischemic, hemorrhage, retreat, and so on
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Jul 2016
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qinghai Huang, Changhai Hospital
- Investigators
- Qinghai Huang, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153748
- Sponsor's protocol ID
- CHEC2017-074
- Acronym
- NATIONAL-2
- Status last verified
- May 2017
- First submitted
- 11 May 2017
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Therapeutic System of Ruptured Intracranial Aneurysms Based on Big Data From Chinese Population
- ClinicalTrials.gov ID
- NCT03153748
- Acronym / sponsor ID
- NATIONAL-2 / CHEC2017-074
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- Treatment strategy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at clarifying the current situation of Emergency treatment of aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the safety and efficacy of the treatment strategy between interventional treatment and open surgery, so as to improve the diagnosis and treatment of aneurysmal SAH.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients presented with subarachnoid hemorrhage and diagnosed with ruptured aneurysm at all age.
Key inclusion criteria (3 listed)
- patients presented with subarachnoid hemorrhage on CT or lumbar puncture.
- the intracranial hemorrhage was caused by rupture of aneurysm and was confirmed on CTA、MRA or DSA.
- patients willing to participate in this clinical trial and attach to regular follow up.
Key exclusion criteria (4 listed)
- intracranial aneurysm correlating to AVM.
- dissection, false, traumatic and infectious aneurysms.
- the rupture of the aneurysm can not be confirmed on CTA、MRA or DSA.
- patients unwilling to participate in this clinical trial and attach to regular follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mRS score
Time frame: 1 year after treatment
the mRS score after treatment
cure rate
Time frame: 6 months after treatment
the proportion of the cured-patient according Raymond Class
2 secondary outcomes
recurrence rate
Time frame: through study completion, an average of 1 year
complication rate
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qinghai Huang, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, Aneurysmal, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pengfei Yang, MD (+86 15921196312, 15921196312@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS score (time frame: 1 year after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.