Evaluation of CTA on the Assessment of Brain Death

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04914039
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain Death	Combination Product: Combination Product; Other: NO CTA examination

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 63 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Evaluation of CTA on the Assessment of Brain Death
• Actual Study Start Date: Feb 1, 2021
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
CTA examination CTA examination group for suspected brain death	Combination Product: Combination Product; Cases of brain death confirmed by the classic brain death confirmation test
Confirmed Confirmed group for brain death	Other: NO CTA examination; NO CTA examination

Outcome Measures

Primary Outcome Measures

1. CTA used as an auxiliary diagnosis to determine brain death [through study completion, an average of 3 years.]

   CTA used as an auxiliary diagnosis to determine brain death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 72 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Recruiting, no definite

Exclusion Criteria:

• Recruiting, no definite

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brain Center, Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04914039
• Other Study ID Numbers: 2020-031
• First Posted: Jun 4, 2021
• Last Update Posted: Jun 4, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University: brain death; CT angiography
• Additional relevant MeSH terms: Brain Death; Death

Study Results

No Results Posted as of Jun 4, 2021