Clemastine in Cardiovascular Surgery

• Status: Completed
• Trial end date: 2020-01-10
• Target enrollment: 0
• Participant gender: All

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 with cardiopulmonary bypass, especially for the efficacy and safety on reducing heparin and protamine associated anaphylaxis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Treatments: Clemastine; Histamine; Histamine H1 Antagonists; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 18-75 years old

• Receiving selective cardiovascular surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease

• Written informed consent obtained.

Exclusion Criteria:

• 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