Disorders of ConsciousnessNCT06403176
Arteriovenous Plasma Multiomics in Patients With Disorders of Consciousness
An observational study of Disorders of Consciousness and Transient Ischemic Attack, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
In order to determine the abnormal cerebral metabolism in the pathological state, we compared the blood of internal jugular vein, superior vena cava and radial artery during central venous catheterization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorders of Consciousness, Transient Ischemic Attack
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Apr 2024
- How long will I take part?
- 12 Months
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with consciousness disorder caused by various severe brain injuries were recruited at Intensive care unit of The First Affiliated Hospital of Zhejiang University and Intensive care unit of the Second Affiliated Hospital of Zhejiang University
Who may be able to join
- 1.Patients with consciousness disorder caused by various severe brain injuries
Who cannot join
- Patients who have been judged brain dead
- There are persistent epileptic activity, inhibition or seizure inhibition patterns
- Recent fever, abnormal liver and kidney function
- Previous history of neurological or mental illness
- Have a history of tumor
- Inflammatory bowel diseases, hyperlipidemia, gastritis
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhejiang University
Hanzhou, Zhejiang, 310003
About this study
Official title: Arteriovenous Plasma Multiomics and Inflammatory Factors in Patients With Disorders of Consciousness
In order to determine the abnormal cerebral metabolism in the pathological state, we compared the blood of internal jugular vein, superior vena cava and radial artery during central venous catheterization. Metabonomics, proteomics and inflammatory factor microarray were used to detect the material differences in arteriovenous blood of patients with disorders of consciousness. At the same time, we concurrently compared it with the peripheral plasma metabolome of two additional patient cohorts: those in-stent restenosis and non-restenosis.
Read the detailed description
Background:It is unclear what substances the brain needs to ingest for its activity under pathological conditions
Method:The uptake and release of substances by the brain were observed by comparing arterial blood with internal jugular vein blood;The characteristics of brain metabolites were observed by comparing internal jugular vein blood with superior vena cava blood. Compared it with the peripheral plasma metabolome of two additional patient cohorts: those in-stent restenosis and non-restenosis.
Objective:By analyzing different substances, this paper briefly describes the pathological mechanism of patients with disorders of consciousness, and looks for potential prognostic biomarkers.
- Being tested
- No intervention
- Keywords
- Plasma metabolism
- Medical subject headings
- Consciousness Disorders, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Minimally conscious state (MCS) | Minimally conscious state (MCS): have reproducible signs of awareness and exhibit fluctuations in consciousness Receives: Other: No intervention | |
| Vegetative state (VS) | Vegetative state (VS): can open their eyes and preserve sleep-wake cycles, but unaware of themselves and their surroundings Receives: Other: No intervention | |
| Patients with In-Stent Restenosis | In-Stent Restenosis was defined as greater than 50% within or immediately adjacent (within 5 mm) to the stent implanted that was detected by digital subtraction angiography (DSA). Receives: Other: No intervention | |
| Patients with Non-Restenosis | In-Stent Restenosis was defined as less than 50% within or immediately adjacent (within 5 mm) to the stent implanted that was detected by digital subtraction angiography (DSA). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient clinical outcome
The patients were followed up for 12 months after blood collection to observe the clinical outcome
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 May 2022
- Primary completion30 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403176
- Sponsor's protocol ID
- plasma multiomics
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arteriovenous Plasma Multiomics and Inflammatory Factors in Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT06403176
- Acronym / sponsor ID
- plasma multiomics
- Keywords
- Plasma metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 7 May 2024 (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.
In order to determine the abnormal cerebral metabolism in the pathological state, we compared the blood of internal jugular vein, superior vena cava and radial artery during central venous catheterization. Metabonomics, proteomics and inflammatory factor microarray were used to detect the material differences in arteriovenous blood of patients with disorders of consciousness. At the same time, we concurrently compared it with the peripheral plasma metabolome of two additional patient cohorts: those in-stent restenosis and non-restenosis.
Detailed description
Background:It is unclear what substances the brain needs to ingest for its activity under pathological conditions
Method:The uptake and release of substances by the brain were observed by comparing arterial blood with internal jugular vein blood;The characteristics of brain metabolites were observed by comparing internal jugular vein blood with superior vena cava blood. Compared it with the peripheral plasma metabolome of two additional patient cohorts: those in-stent restenosis and non-restenosis.
Objective:By analyzing different substances, this paper briefly describes the pathological mechanism of patients with disorders of consciousness, and looks for potential prognostic biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Minimally conscious state (MCS) | – | Other: No interventionMinimally conscious state (MCS): have reproducible signs of awareness and exhibit fluctuations in consciousness |
| Vegetative state (VS) | – | Other: No interventionVegetative state (VS): can open their eyes and preserve sleep-wake cycles, but unaware of themselves and their surroundings |
| Patients with In-Stent Restenosis | – | Other: No interventionIn-Stent Restenosis was defined as greater than 50% within or immediately adjacent (within 5 mm) to the stent implanted that was detected by digital subtraction angiography (DSA). |
| Patients with Non-Restenosis | – | Other: No interventionIn-Stent Restenosis was defined as less than 50% within or immediately adjacent (within 5 mm) to the stent implanted that was detected by digital subtraction angiography (DSA). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with consciousness disorder caused by various severe brain injuries were recruited at Intensive care unit of The First Affiliated Hospital of Zhejiang University and Intensive care unit of the Second Affiliated Hospital of Zhejiang University
Key inclusion criteria (1 listed)
- 1.Patients with consciousness disorder caused by various severe brain injuries
Key exclusion criteria (6 listed)
- Patients who have been judged brain dead
- There are persistent epileptic activity, inhibition or seizure inhibition patterns
- Recent fever, abnormal liver and kidney function
- Previous history of neurological or mental illness
- Have a history of tumor
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 |
|---|---|---|
| No interventionNo intervention | Other | Minimally conscious state (MCS), Patients with In-Stent Restenosis, Patients with Non-Restenosis, Vegetative state (VS) |
Primary outcome
Patient clinical outcome
Time frame: 12 months
The patients were followed up for 12 months after blood collection to observe the clinical outcome
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 7 May 2024.
- Individual participant dataSharing planned: No
Related trials for Disorders of Consciousness
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 2
Restoring Awareness
Vegetative State, Minimally Conscious State
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Disorders of Consciousness and Transient Ischemic Attack, run by First Affiliated Hospital of Zhejiang 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 6 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 7 May 2024. 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?
Patient clinical outcome (time frame: 12 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 7 May 2024.