Subarachnoid Hemorrhage, AneurysmalNCT01567449
Risk Factors for Aneurysm Rebleeding
An observational study of Subarachnoid Hemorrhage, Aneurysmal, run by Fujian Medical University at 1 site in China.
Trial summary
The purpose of this study is to examine the risk factors for aneurysm rebleeding. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Apr 2012
- 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: A total of 66 SAH patients were enrolled in this study
Who may be able to join
- Individual whose clinical course was clear enough to be traced back and whose conservative treatment duration was shorter than 6 weeks was included
Who cannot join
- Rebleeding patients with certain inducing factors such as:
- severe emotional episode,
- severe coughing,
- constipation,
- excessive activities, or
- with coagulation disorder,or
Show all 10Show fewer
- with other intracranial vascular malformations,such as:
- moyamoya disease,
- arteriovenous malformation were excluded.
- Also patients who rebled while angiography were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital,Fujian Medical University
Fuzhou, Fujian, 350005
Dezhi kang, professor, 13859099988, kdz99988@sina.com
About this study
Official title: Risk Factors in Predicting Spontaneous Intracranial Aneurysm Rebleeding During Hospitalization
The purpose of this study is to examine the risk factors for aneurysm rebleeding.
Read the detailed description
To investigate risk factors for spontaneous aneurysm rebleeding during hospitalization and to reach conclusions if any,of clinical signs for predicting rebleeding.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the case group | The case group referred to SAH patients with aneurysm rebleeding | |
| the control group | the control group referred to SAH patients not with aneurysm rebleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm rebleeding
Measured: up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionApr 2012 (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 Fujian Medical UniversityThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingsong Lin, Fujian Medical University
- Investigators
- Dezhi kang, professor, Study director, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567449
- Sponsor's protocol ID
- 110011
- Status last verified
- Mar 2012
- First submitted
- 25 Mar 2012
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors in Predicting Spontaneous Intracranial Aneurysm Rebleeding During Hospitalization
- ClinicalTrials.gov ID
- NCT01567449
- Acronym / sponsor ID
- 110011
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (estimated)
- First posted
- 30 Mar 2012 (estimated)
- 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.
The purpose of this study is to examine the risk factors for aneurysm rebleeding.
Detailed description
To investigate risk factors for spontaneous aneurysm rebleeding during hospitalization and to reach conclusions if any,of clinical signs for predicting rebleeding.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the case group | – | –The case group referred to SAH patients with aneurysm rebleeding |
| the control group | – | –the control group referred to SAH patients not with aneurysm rebleeding |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 66 SAH patients were enrolled in this study
Key inclusion criteria (1 listed)
- Individual whose clinical course was clear enough to be traced back and whose conservative treatment duration was shorter than 6 weeks was included
Key exclusion criteria (10 listed)
- Rebleeding patients with certain inducing factors such as:
- Also patients who rebled while angiography were excluded.
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
Aneurysm rebleeding
Time frame: up to 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
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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.
Dezhi kang, professor study director
First Affiliated Hospital of Fujian Medical University
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 Fujian Medical University 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 1 inclusion and 10 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 30 Mar 2012. 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 qingsong lin, master (13489991226, lqs1210305061@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aneurysm rebleeding (time frame: up to 7 months). 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 30 Mar 2012.