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NCT Number: NCT03826004

Clemastine in Cardiovascular Surgery

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.

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Key information

Conditions

Efficacy and Safety Anaphylaxis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clemastine

Drug

Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle

Saline Solution

Drug

Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle

Primary outcomes

  1. Histamine concentration in plasma

    Time frame: Perioperative period

    Plasma histamine concentration evaluated by ELISA

Secondary outcomes

  1. Blood pressure

    Time frame: Perioperative period

    Invasive blood pressure of radial artery: systolic, diastolic and mean pressure

  2. Airway pressure

    Time frame: Perioperative period

    Airway pressure: peak and plat

  3. Skin manifestation

    Time frame: Perioperative period

    Rate of skin manifestations, including wheal, papules, maculopapules, etc

  4. Arrhythmia

    Time frame: Perioperative period

    Rate of perioperative arrhythmia, especially tachycardia

  5. Specific symptoms

    Time frame: Perioperative period

    Rate of specific symptoms, including fatigue, sleepiness, dizziness, headache, stomach pain, constipation, nausea, dry mouth

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 1, 2019
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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