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Clemastine in Cardiovascular Surgery

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ClinicalTrials.gov Identifier: NCT03826004
Recruitment Status : Active, not recruiting
First Posted : February 1, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Efficacy and Safety Drug: Clemastine Drug: Saline Solution Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Histamine H1 Receptor Antagonist Clemastine in Cardiovascular Surgery With Cardiopulmonary Bypass: A Pilot Study
Actual Study Start Date : February 20, 2019
Actual Primary Completion Date : July 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Histamine concentration in plasma [ Time Frame: Perioperative period ]
    Plasma histamine concentration evaluated by ELISA


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826004


Locations
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China, Beijing
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing, China, 100037
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
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Study Chair: Jia Shi, M.D. Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

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Responsible Party: SHI Jia, Assoticate Professor, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03826004     History of Changes
Other Study ID Numbers: Clemastine Pilot Study
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital:
Cardiovascular Surgery
Histamine H1 Receptor Antagonist
Anaphylaxis
Additional relevant MeSH terms:
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Histamine
Histamine H1 Antagonists
Histamine Agonists
Histamine Agents
Histamine Antagonists
Clemastine
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents
Anti-Allergic Agents