Clemastine in Cardiovascular Surgery

Overview

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Triple (Participant, Care Provider, Investigator)
• Study Primary Completion Date: July 31, 2019

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

Interventions

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

Arms, Groups and Cohorts

• Placebo Comparator: Placebo
  • Saline solution 2ml before anesthetic induction
• Experimental: Clemastine
  • Clemastine fumarate 2mg/2ml before anesthetic induction

Clinical Trial Outcome Measures

Primary Measures

• Histamine concentration in plasma
  • Time Frame: Perioperative period
  • Plasma histamine concentration evaluated by ELISA

Secondary Measures

• Blood pressure
  • Time Frame: Perioperative period
  • Invasive blood pressure of radial artery: systolic, diastolic and mean pressure
• Airway pressure
  • Time Frame: Perioperative period
  • Airway pressure: peak and plat
• Skin manifestation
  • Time Frame: Perioperative period
  • Rate of skin manifestations, including wheal, papules, maculopapules, etc
• Arrhythmia
  • Time Frame: Perioperative period
  • Rate of perioperative arrhythmia, especially tachycardia
• Specific symptoms
  • Time Frame: Perioperative period
  • Rate of specific symptoms, including fatigue, sleepiness, dizziness, headache, stomach pain, constipation, nausea, dry mouth

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Chinese Academy of Medical Sciences, Fuwai Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: SHI Jia, Assoticate Professor – Chinese Academy of Medical Sciences, Fuwai Hospital
• Overall Official(s)
  • Jia Shi, M.D., Study Chair, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC