Gastrodin prevents cognitive decline related to cardiopulmonary bypass

ISRCTN	ISRCTN47168298
DOI	https://doi.org/10.1186/ISRCTN47168298
ClinicalTrials.gov number	NCT00297245
Secondary identifying numbers	FWA00007304

Submission date: 25/02/2006
Registration date: 25/04/2006
Last edited: 11/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Shihai Zhang
Scientific

1277 Jiefang Street
Wuhan
430022
China

Study information

Study design	Double-blind, randomized controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title	Gastrodin prevents cognitive decline related to cardiopulmonary bypass
Study objectives	Cardiopulmonary bypass (CPB) is associated with significant cerebral morbidity. The incidence of cognitive decline related to CPB ranges from 20% to 80%. However, there is no effective method to prevent the decline. We postulate that gastrodin would attenuate the causative parameters of cognitive dysfunction related to CPB and would be an effective drug to prevent the decline as a result.
Ethics approval(s)	Approved by the Ethics Committee at Tongji Medical College on 19/01/2006, reference number: FWA00007304
Health condition(s) or problem(s) studied	Neurocognitive decline related to CPB
Intervention	Patients are randomized to receive either one the following interventions: 1. Gastrodin (40 mg/kg in 50 ml saline) will be injected intravenously with a pump within 45 minutes after induction of anesthesia 2. Saline 50 ml will be injected intravenously with a pump within 45 minutes after induction of anesthesia
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Gastrodin
Primary outcome measure	Neurocognitive function
Secondary outcome measures	Safety of gastrodin
Overall study start date	01/03/2006
Completion date	01/06/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200
Total final enrolment	200
Key inclusion criteria	Adult patients (18 to 65 years) that have undergone mitral valve replacement surgery
Key exclusion criteria	1. Patients who have thrombosis in left atrium 2. A history of symptomatic cerebrovascular disease 3. Diabetes 4. Psychiatric illness 5. Renal disease or active liver disease 6. Less than a seven-grade education or those who cannot read will be excluded
Date of first enrolment	01/03/2006
Date of final enrolment	01/06/2006

Locations

Countries of recruitment

China

Study participating centre

1277 Jiefang Street

Wuhan
430022
China

Sponsor information

Tongji Medical College (China)
Hospital/treatment centre

13 Hangkong Road
Wuhan
430030
China

"ROR"	https://ror.org/00p991c53

Funders

Funder type

Research organisation

Supported by Grant (30271255) from the National Science Foundation of China.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2011	11/01/2021	Yes	No

Editorial Notes

11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NCT numbers has been added.