Subarachnoid Hemorrhage, Aneurysmal Clinical Trial
— CIAP-5Official title:
A Registry Study for Emergency Medical Service of Aneurysmal Subarachnoid Hemorrhage With Different Economic Development Levels Areas in China
NCT number | NCT03115905 |
Other study ID # | 2016YFC1300805 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | June 30, 2021 |
Verified date | September 2021 |
Source | Xuanwu Hospital, Beijing |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This is a staged registry study of early treatment strategy management of acute aneurysmal subarachnoid hemorrhage(aSAH) among different economic development levels areas in China. First stage, the study will investigate and register the basic information of emergency treatment management for the acute aSAH in 20 different grade centers located in different economic levels districts including Northeast part, Northern, Eastern, South-central, Northwest, Southwest and Qinghai-Tibet of China. Comparing the the outcome of acute aSAH to find the critical factors to affect it by statistical analysis. Then,the investigators will offer some suggestions to adjust the measures to improve the efficacy of emergency medical service for acute SAH. Second stage, to evaluate the outcome after applying the new suggestion of self-control methods. The investigators hypothesis that there is an appropriate green pathway in different districts to shorten the rescuing time, improve the curative effects.
Status | Completed |
Enrollment | 6000 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility | Inclusion Criteria: 1. Proven subarachnoid haemorrhage on computed tomography(CT) or lumbar puncture less than 14 days. 2. Exist at least one target intracranial aneurysm demonstrated by computed tomography angiography (CTA) or Digital Subtraction Angiography(DSA). 3. Age is older than 14 years old. 4. Patient or relatives agreed to sign the consent form. Exclusion Criteria: 1. Some special types of controversial aneurysmal subarachnoid hemorrhage such as caused by blood blister-like aneurysm,dissection aneurysm and so on. 2. Participation in another randomised drug or clinical trial for subarachnoid hemorrhage. 3. Refusal of consent. 4. Women during pregnancy. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Neurosurgical Institute | Beijing | Beijing |
China | Neurosurgery Department of Xuanwu hospital, Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing | Ministry of Science and Technology of the People's Repubic of China |
China,
Britz GW. ISAT trial: coiling or clipping for intracranial aneurysms? Lancet. 2005 Sep 3-9;366(9488):783-5. — View Citation
Darsaut TE, Raymond J. Barrow Ruptured Aneurysm Trial: 3-year results. J Neurosurg. 2013 Dec;119(6):1642-4. doi: 10.3171/2013.5.JNS13917. Epub 2013 Aug 30. — View Citation
Mitha AP, Ogilvy CS. ISAT: coiling or clipping for ruptured intracranial aneurysms? Lancet Neurol. 2005 Dec;4(12):791-2. — View Citation
Molyneux A, Kerr R; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group, Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in — View Citation
Molyneux AJ, Birks J, Clarke A, Sneade M, Kerr RS. The durability of endovascular coiling versus neurosurgical clipping of ruptured cerebral aneurysms: 18 year follow-up of the UK cohort of the International Subarachnoid Aneurysm Trial (ISAT). Lancet. 201 — View Citation
Thomas AJ, Ogilvy CS. ISAT: equipoise in treatment of ruptured cerebral aneurysms? Lancet. 2015 Feb 21;385(9969):666-8. doi: 10.1016/S0140-6736(14)61736-0. Epub 2014 Oct 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The rate of treatment success | We defined the aneurysm was totally or nearly occluded identified by the Digital Subtraction Angiography(DSA). | Immediate evaluating after treatment | |
Other | The rate of treatment success | We defined the aneurysm was totally or nearly occluded identified by the Digital Subtraction Angiography(DSA). | Six months after treatment. | |
Other | The rate of main adverse events | We defined the main adverse events includes any deaths and ischemia or hemorrhage related to the treatment during 30 days after treatment, and neurologic complications from 30 days after treatment to 1 year. | duration of hospital stay | |
Other | The rate of main adverse events | We defined the main adverse events includes any deaths and ischemia or hemorrhage related to the treatment during 30 days after treatment, and neurologic complications from 30 days after treatment to 1 year. | 3 months after discharge. | |
Other | The rate of main adverse events | We defined the main adverse events includes any deaths and ischemia or hemorrhage related to the treatment during 30 days after treatment, and neurologic complications from 30 days after treatment to 1 year. | 6 months after discharge. | |
Other | The rate of main adverse events | We defined the main adverse events includes any deaths and ischemia or hemorrhage related to the treatment during 30 days after treatment, and neurologic complications from 30 days after treatment to 1 year. | 1 year after discharge. | |
Primary | the rate of modified Rankin Score(mRS) higher than 3. | It means that the rate of disability and mortality. | 3 months after treatment |
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