Clemastine in Cardiovascular Surgery

January 10, 2020 updated by: SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Saline solution 2ml before anesthetic induction
Drug: Saline Solution
Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle
Experimental: Clemastine
Clemastine fumarate 2mg/2ml before anesthetic induction
Drug: Clemastine
Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histamine concentration in plasma
Time Frame: Perioperative period
Plasma histamine concentration evaluated by ELISA
Perioperative period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Study Chair: Jia Shi, M.D., Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2019

Primary Completion (Actual)

July 31, 2019

Study Completion (Actual)

January 10, 2020

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Clemastine Pilot Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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