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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03153748
Other study ID # CHEC2017-074
Secondary ID
Status Recruiting
Phase N/A
First received May 11, 2017
Last updated May 12, 2017
Start date July 1, 2016
Est. completion date December 31, 2020

Study information

Verified date May 2017
Source Changhai Hospital
Contact Pengfei Yang, MD
Phone +86 15921196312
Email 15921196312@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Changhai Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary mRS score the mRS score after treatment 1 year after treatment
Primary cure rate the proportion of the cured-patient according Raymond Class 6 months after treatment
Secondary recurrence rate the proportion of the recurrence of the patient through study completion, an average of 1 year
Secondary complication rate the proportion of complication happened after treatment including ischemic, hemorrhage, retreat, and so on through study completion, an average of 1 year
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