NCT04728438

Brief Summary

Change and effect of cerebral autoregulation during targeted temperature management in neurocritical patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

January 28, 2021

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

January 21, 2021

Last Update Submit

January 26, 2021

Conditions

Ischemic StrokeSubarachnoid Hemorrhage, AneurysmalSepsisTBI (Traumatic Brain Injury)ICH - Intracerebral HemorrhageHIE - Hypoxic - Ischemic Encephalopathy

Keywords

cerebral autoregulation, targeted temperature management

Outcome Measures

Primary Outcomes (1)

  • discharge mortality

    Mortality of patients included in the study

    mortality when patients discharge，an average of 7days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People who need to reduce the core temperature to normal

You may qualify if:

  • \- Aneurysmal subarachnoid hemorrhage (aSAH), Traumatic brain injury (TBI), Acute ischemic stroke (AIS), Intracerebral hemorrhage (ICH), Ischemic hypoxic encephalopathy (HIE), sepsis-associated encephalopathy (SAE) who need to reduce the core temperature to normal.

You may not qualify if:

  • Age \< 18 years old;
  • Pregnancy;
  • The temporal window was limited and the image could not be obtained;
  • Patients with bradycardia induced by common carotid artery compression and intolerant of THRT
  • Patients with severe carotid artery disease;
  • Uncorrected severe coagulation disorders and active bleeding;
  • Patients without informed consent;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Ischemic StrokeSubarachnoid HemorrhageSepsisBrain Injuries, TraumaticCerebral Hemorrhage

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammationBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Lina Zhang, PhD

    Xiangya University,Central South University

    STUDY CHAIR

Central Study Contacts

Lina Zhang, PhD

CONTACT

+8615874875763zln7095@163.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 28, 2021

Study Start

January 22, 2021

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

January 28, 2021

Record last verified: 2020-12

Locations

CN(1)