Status:
COMPLETED
Clemastine in Cardiovascular Surgery
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Efficacy and Safety
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in cardiovascular surgery...
Detailed Description
In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in cardiovascular surgery...
Eligibility Criteria
Inclusion
- 18-75 years old
- Receiving selective cardiovascular surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
- Written informed consent obtained.
Exclusion
- Previous history of cardiac surgery
- Allergy to clemastine, antihistamines with similar chemical structure or any excipient (sorbitol, sodium citrate, propylene glycol, ethanol)
- Myasthenia gravis
- Porphyria patients
- Bronchial asthma
- Usage of monoamine oxidase (MAO) inhibitors
- Pregnant or lactating women
- Mentally or legally disabled patients
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03826004
Start Date
February 20 2019
End Date
January 10 2020
Last Update
January 13 2020
Active Locations (1)
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1
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China, 100037