Clemastine in Cardiovascular Surgery

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Completed

Conditions: Efficacy and Safety

Treatments: Drug: Saline Solution; Drug: Clemastine

Study type: Interventional

Funder types: Other

Identifiers

NCT03826004

Clemastine Pilot Study

Details and patient eligibility

About

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.

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Saline solution 2ml before anesthetic induction

Treatment:

Drug: Saline Solution

Clemastine

Experimental group

Description:

Clemastine fumarate 2mg/2ml before anesthetic induction

Treatment:

Drug: Clemastine