NCT06403176

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
Last Updated

May 7, 2024

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

March 14, 2022

Last Update Submit

May 6, 2024

Conditions

Keywords

Plasma metabolism

Outcome Measures

Primary Outcomes (1)

  • Patient clinical outcome

    The patients were followed up for 12 months after blood collection to observe the clinical outcome

    12 months

Study Arms (4)

Minimally conscious state (MCS)

Minimally conscious state (MCS): have reproducible signs of awareness and exhibit fluctuations in consciousness

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

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).

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).

Other: No intervention

Interventions

No intervention

Minimally conscious state (MCS)Patients with In-Stent RestenosisPatients with Non-RestenosisVegetative state (VS)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Patients with consciousness disorder caused by various severe brain injuries

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hanzhou, Zhejiang, 310003, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma for metabolites and lipids

MeSH Terms

Conditions

Consciousness DisordersIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2022

First Posted

May 7, 2024

Study Start

May 1, 2022

Primary Completion

March 30, 2024

Study Completion

April 30, 2024

Last Updated

May 7, 2024

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations