Condition category
Nervous System Diseases
Date applied
25/02/2006
Date assigned
25/04/2006
Last edited
25/04/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Shihai Zhang

ORCID ID

Contact details

1277 Jiefang Street
Wuhan
430022
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FWA00007304

Study information

Scientific title

Acronym

Study hypothesis

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

Approved by the Ethics Committee at Tongji Medical College on 19/01/2006, reference number: FWA00007304

Study design

Double-blind, randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Gastrodin

Primary outcome measures

Neurocognitive function

Secondary outcome measures

Safety of gastrodin

Overall trial start date

01/03/2006

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients (18 to 65 years) that have undergone mitral valve replacement surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

01/03/2006

Recruitment end date

01/06/2006

Locations

Countries of recruitment

China

Trial participating centre

1277 Jiefang Street
Wuhan
430022
China

Sponsor information

Organisation

Tongji Medical College (China)

Sponsor details

13 Hangkong Road
Wuhan
430030
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes