Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery

Nanjing Medical University

Status

Not yet enrolling

Conditions

Brain Injury

Cardio-pulmonary Bypass

Cardiovascular Surgery

Cerebral Protection

Treatments

Drug: Angong Niuhuang Pill (ANP)

Other: Control (Standard treatment)

Study type

Interventional

Funder types

Other

Identifiers

NCT06723366

PANDA X

Details and patient eligibility

About

Neurologic Dysfunction is one of the main factors contributing to poor outcomes in cardiac surgery patients, except for heart failure. Atherosclerosis of the aorta, a history of cerebral infarction, and cervical artery disease are common clinical risk factors for cerebral neurological dysfunction after cardiac surgery. Results of preclinical studies suggested that Angong Niuhuang Pills (ANPs), a traditional Chinese patent medicine, including realgar, cinnabaris, Bovis Calculus, artificial Moschus, and powdered buffalo horn extract, decreased infarct volume and cerebral edema, and presented anti- atherosclerosis and cardio-protective effects in clinical and preclinical studies. The PANDA X trial is designed as a pilot study to explore the safety and efficacy of ANP in patients with moderate-to-severe neurologic dysfunction after cardiovascular surgery.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

(1) an age > 18 years,
(2) underwent cardiovascular surgery,
(3) diagnosis of acute neurologic dysfunction, including but not limited acute cerebral infarction of the internal carotid artery system,
(4) a National Institutes of Health Stroke Scale (NIHSS) score ranging from 10 to 20,
(5) a time from symptom onset to randomization within 36 h,
(6) provision of informed consent.

Exclusion criteria

(1) not suitable for taking ANP after the dialectical process by a traditional Chinese medical doctor,
(2) received ANP within 1 month before stroke onset,
(3) liver failure,
(4) declined to participate in this study.