Subarachnoid Hemorrhage, AneurysmalNCT04938414
Investigate the Relationship Between Inflammatory and Coagulation in SAH CSF
An observational study of Subarachnoid Hemorrhage, Aneurysmal, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Investigate the role of inflammasome and blood coagulation response in human cerebrospinal fluid after subarachnoid hemorrhage. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Lumbar puncture
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Oct 2021
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with SAH
Who may be able to join
- SAH patients with modified Fisher Scale 3-4.
Who cannot join
- Patients with history of CNS disease (e.g., stroke, traumatic brain injury, CNS infection) or accompanied by serious comorbidities before SAH onset (e.g., severe coagulation disorders, malignant tumor, uncontrollable heart disease, and hypertension) or other organ dysfunctions within 6 months were excluded from the study
Trial locations and contacts
1 site in 1 country.
China1 site
Second affiliated hosipital of zhejiang univerisity school of medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: Inhibition of Caspase-1 Reduces Pyroptotic Neuroinflammation and Tissue Factor-Induced Cerebrospinal Fluid Circulation Impairment After Subarachnoid Hemorrhage
Investigate the role of inflammasome and blood coagulation response in human cerebrospinal fluid after subarachnoid hemorrhage.
Read the detailed description
Investigate the role of inflammasome and blood coagulation response in human cerebrospinal fluid after subarachnoid hemorrhage (SAH).
1.40 patients with SAH will be included. The CSF will used for ELISA test for inflammatory factors and cogulation factors.
2.CSF obtained from 4 patients with non-neuroloogical disease with 4 addittional SAH patients will be used for Mass Spectrometry
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- Lumbar puncture
- Keywords
- subarachnoid hemorrhage, coagulation, inflammation
- Medical subject headings
- Subarachnoid Hemorrhage, Thrombosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar punctureDiagnostic test
Lumbar puncture to obtain the cerebrospinal fluid and for diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| subarachnoid hemorrhage | Patients with subarachnoid hemorrhage Receives: Diagnostic Test: Lumbar puncture | |
| Control | patients with non-neurological diseases Receives: Diagnostic Test: Lumbar puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Length of hospital stay
Measured: evaluated 1day after discharge
modified Rankin Scale
modified Rankin Scale (mRS) at discharge. mRS ranging from 0-5, higher represents worse
Measured: evaluated 1day after discharge
Glasgow Outcome Scale
Glasgow Outcome Scale (GOS) at discharge, GOS ranging from 0-5, higher represents better
Measured: evaluated 1day after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Dec 2020
- Primary completion1 Aug 2021
- Study completion1 Oct 2021
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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuanjian Fang, M.D, Study chair, Zhejiang Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938414
- Sponsor's protocol ID
- 2020-892
- Status last verified
- Jun 2021
- First submitted
- 21 Jun 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- 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 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition of Caspase-1 Reduces Pyroptotic Neuroinflammation and Tissue Factor-Induced Cerebrospinal Fluid Circulation Impairment After Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT04938414
- Acronym / sponsor ID
- 2020-892
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- subarachnoid hemorrhage, coagulation, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 24 Jun 2021 (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.
Investigate the role of inflammasome and blood coagulation response in human cerebrospinal fluid after subarachnoid hemorrhage.
Detailed description
Investigate the role of inflammasome and blood coagulation response in human cerebrospinal fluid after subarachnoid hemorrhage (SAH).
1.40 patients with SAH will be included. The CSF will used for ELISA test for inflammatory factors and cogulation factors.
2.CSF obtained from 4 patients with non-neuroloogical disease with 4 addittional SAH patients will be used for Mass Spectrometry
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subarachnoid hemorrhage | – | Diagnostic Test: Lumbar puncturePatients with subarachnoid hemorrhage |
| Control | – | Diagnostic Test: Lumbar puncturepatients with non-neurological diseases |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with SAH
Key inclusion criteria (1 listed)
- SAH patients with modified Fisher Scale 3-4.
Key exclusion criteria (1 listed)
- Patients with history of CNS disease (e.g., stroke, traumatic brain injury, CNS infection) or accompanied by serious comorbidities before SAH onset (e.g., severe coagulation disorders, malignant tumor, uncontrollable heart disease, and hypertension) or other organ dysfunctions within 6 months were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar punctureLumbar puncture to obtain the cerebrospinal fluid and for diagnostic test | Diagnostic test | Control, subarachnoid hemorrhage |
Primary outcome
Length of hospital stay
Time frame: evaluated 1day after discharge
Length of hospital stay
modified Rankin Scale
Time frame: evaluated 1day after discharge
modified Rankin Scale (mRS) at discharge. mRS ranging from 0-5, higher represents worse
Glasgow Outcome Scale
Time frame: evaluated 1day after discharge
Glasgow Outcome Scale (GOS) at discharge, GOS ranging from 0-5, higher represents better
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- 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.
Yuanjian Fang, M.D study chair
Zhejiang Univerisity
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 Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 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: finished, as of the sponsor's last update on 6 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: evaluated 1day after discharge). The study lists 3 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 6 Jan 2022.