Clemastine in Cardiovascular Surgery

Efficacy and Safety Clinical Trial

Official title:

Effect of Histamine H1 Receptor Antagonist Clemastine in Cardiovascular Surgery With Cardiopulmonary Bypass: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826004
• Other study ID #: Clemastine Pilot Study
• Status: Completed
• Phase: N/A
• Start date: February 20, 2019
• Est. completion date: January 10, 2020

Study information

• Verified date: January 2020
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 10, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Efficacy and Safety

Intervention

Drug:
• Clemastine
Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle
• Saline Solution
Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle

Locations

Country	Name	City	State
China	Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histamine concentration in plasma	Plasma histamine concentration evaluated by ELISA	Perioperative period
Secondary	Blood pressure	Invasive blood pressure of radial artery: systolic, diastolic and mean pressure	Perioperative period
Secondary	Airway pressure	Airway pressure: peak and plat	Perioperative period
Secondary	Skin manifestation	Rate of skin manifestations, including wheal, papules, maculopapules, etc	Perioperative period
Secondary	Arrhythmia	Rate of perioperative arrhythmia, especially tachycardia	Perioperative period
Secondary	Specific symptoms	Rate of specific symptoms, including fatigue, sleepiness, dizziness, headache, stomach pain, constipation, nausea, dry mouth	Perioperative period