Evaluation of CTA on the Assessment of Brain Death

Brain Death Clinical Trial

Official title:

Evaluation of CTA on the Assessment of Brain Death

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04914039
• Other study ID #: 2020-031
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

At present, different countries have different standards for the diagnosis of brain death, but according to the classic brain death confirmation test, it needs to be combined with transcranial Doppler, EEG, evoked potential and apnea test in clinical practice. Some patients cannot undergo a complete clinical examination and apnea test due to certain factors, and the determination of brain death is limited. The American Academy of Neurology (AAN) guidelines regard cerebral angiography as an acceptable auxiliary examination and is widely regarded as the gold standard for cerebral blood flow evaluation. CT cerebrovascular angiography (CTA) is a noninvasive and widely used examination method that can identify missing or severely reduced cerebral blood flow. However, due to limited experience and lack of sufficient evidence to prove its reliability, it is not included in the AAN A recognized auxiliary examination; there are also a large number of domestic and foreign literature reports that CTA can be used as a new confirmation test for clinical judgment of brain death. This study aims to explore the value of CTA in the judgment of patients with brain death.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 72 Years

Eligibility

Inclusion Criteria:

• Recruiting, no definite

Exclusion Criteria:

• Recruiting, no definite

Related Conditions & MeSH terms

• Brain Death
• Death

Intervention

Combination Product:
• Combination Product
Cases of brain death confirmed by the classic brain death confirmation test

Other:
• NO CTA examination
NO CTA examination

Locations

Country	Name	City	State
China	Brain Center, Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTA used as an auxiliary diagnosis to determine brain death	CTA used as an auxiliary diagnosis to determine brain death	through study completion, an average of 3 years.