Clemastine in Cardiovascular Surgery | NCT03826004

Studies
Clemastine in Cardiovascular Surgery

NCT03826004

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Completed

Last Update Posted

Jan 13, 2020Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Efficacy and Safety

Interventions

Clemastine
Saline Solution

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2019Actual

Primary Completion Date

Jul 31, 2019Actual

Completion Date

Jan 10, 2020Actual

First Submitted Date

Jan 30, 2019

First Submission Date that Met QC Criteria

Jan 30, 2019

First Posted Date

Feb 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2020

Last Update Posted Date

Jan 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

SHI Jia, Assoticate Professor, Chinese Academy of Medical Sciences, Fuwai HospitalPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Saline solution 2ml before anesthetic induction	Drug: Saline Solution
Clemastine	Experimental	Clemastine fumarate 2mg/2ml before anesthetic induction	Drug: Clemastine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clemastine	Drug	Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle	Clemastine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure	Invasive blood pressure of radial artery: systolic, diastolic and mean pressure	Perioperative period
Airway pressure	Airway pressure: peak and plat

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jia Shi, M.D.	Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC		Beijing	Beijing Municipality	100037	China

Condition Browse Module

MeSH Terms

ID	Term
D000707	Anaphylaxis

Ancestor Terms

ID	Term
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002974	Clemastine
D000077330	Saline Solution

Ancestor Terms

ID	Term
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000077324	Crystalloid Solutions

Browse Leaves

Not provided

Browse Branches

Not provided