Evaluation of CTA on the Assessment of Brain Death

NCT04914039 | Unknown FDA Drug

• 1 other identifier: 2020-031
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Death

Keywords

brain death; CT angiography

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

CTA examination

CTA examination group for suspected brain death

Combination Product: Combination Product

Confirmed

Confirmed group for brain death

Other: NO CTA examination

Interventions

Combination Product COMBINATION_PRODUCT

Cases of brain death confirmed by the classic brain death confirmation test

CTA examination

NO CTA examination OTHER

NO CTA examination

Confirmed

Eligibility Criteria

• Age: 12 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CTA imaging data of 63 patients with clinically suspected brain death

You may qualify if:

• Recruiting, no definite

You may not qualify if:

• Recruiting, no definite

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Brain Center, Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Brain Death

Interventions

Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 4, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2023
• Last Updated: June 4, 2021

Record last verified: 2021-05

Locations

CN (1)