Clemastine in Cardiovascular Surgery
Effect of Histamine H1 Receptor Antagonist Clemastine in Cardiovascular Surgery With Cardiopulmonary Bypass: A Pilot Study
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2019
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedStudy Start
First participant enrolled
February 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2020
CompletedJanuary 13, 2020
January 1, 2020
5 months
January 30, 2019
January 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Histamine concentration in plasma
Plasma histamine concentration evaluated by ELISA
Perioperative period
Secondary Outcomes (5)
Blood pressure
Perioperative period
Airway pressure
Perioperative period
Skin manifestation
Perioperative period
Arrhythmia
Perioperative period
Specific symptoms
Perioperative period
Study Arms (2)
Placebo
PLACEBO COMPARATORSaline solution 2ml before anesthetic induction
Clemastine
EXPERIMENTALClemastine fumarate 2mg/2ml before anesthetic induction
Interventions
Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle
Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle
Eligibility Criteria
You may qualify if:
- years old
- Receiving selective cardiovascular surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
- Written informed consent obtained.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, 100037, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jia Shi, M.D.
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoticate Professor
Study Record Dates
First Submitted
January 30, 2019
First Posted
February 1, 2019
Study Start
February 20, 2019
Primary Completion
July 31, 2019
Study Completion
January 10, 2020
Last Updated
January 13, 2020
Record last verified: 2020-01