Clemastine in Cardiovascular Surgery

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03826004
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.6
• Patients Per Site Per Month: 9.4

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Feb 20, 2019
• Actual Primary Completion Date: Jul 31, 2019
• Actual Study Completion Date: Jan 10, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Histamine concentration in plasma [Perioperative period]

   Plasma histamine concentration evaluated by ELISA

Secondary Outcome Measures

1. Blood pressure [Perioperative period]

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

2. Airway pressure [Perioperative period]

   Airway pressure: peak and plat

3. Skin manifestation [Perioperative period]

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

4. Arrhythmia [Perioperative period]

   Rate of perioperative arrhythmia, especially tachycardia

5. Specific symptoms [Perioperative period]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC	Beijing	Beijing	China	100037

Sponsors and Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SHI Jia, Assoticate Professor, Chinese Academy of Medical Sciences, Fuwai Hospital
• ClinicalTrials.gov Identifier: NCT03826004
• Other Study ID Numbers: Clemastine Pilot Study
• First Posted: Feb 1, 2019
• Last Update Posted: Jan 13, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by SHI Jia, Assoticate Professor, Chinese Academy of Medical Sciences, Fuwai Hospital: Cardiovascular Surgery; Histamine H1 Receptor Antagonist; Anaphylaxis
• Additional relevant MeSH terms: Clemastine

Study Results

No Results Posted as of Jan 13, 2020