About this trial
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.
Eligibility criteria
Qualifiers
(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,
Disqualifiers
(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.
Trial design
Treatments tested in this trial
- Angong Niuhuang Pill (ANP)
- Control (Standard treatment)
Treatment groups
Sponsors and collaborators
Nanjing Medical University
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Beijing Anzhen Hospital
Collaborator