Efficacy and SafetyNCT03826004
Clemastine in Cardiovascular Surgery
A study testing Clemastine and Saline Solution in people with Efficacy and Safety, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Efficacy and Safety
- What is being tested?
- Clemastine and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2019to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old
- Receiving selective cardiovascular surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
- Written informed consent obtained.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, 100037
About this study
Official title: 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.
Read the 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.
- Conditions
- Efficacy and Safety
- Being tested
- Clemastine, Saline Solution
- Keywords
- Cardiovascular Surgery, Histamine H1 Receptor Antagonist, Anaphylaxis
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClemastineDrug
Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle
Saline SolutionDrug
Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline solution 2ml before anesthetic induction Receives: Drug: Saline Solution |
| Clemastine | Experimental | Clemastine fumarate 2mg/2ml before anesthetic induction Receives: Drug: Clemastine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histamine concentration in plasma
Plasma histamine concentration evaluated by ELISA
Measured: Perioperative period
Secondary outcomes (5)
Blood pressure
Invasive blood pressure of radial artery: systolic, diastolic and mean pressure
Measured: Perioperative period
Airway pressure
Airway pressure: peak and plat
Measured: Perioperative period
Skin manifestation
Rate of skin manifestations, including wheal, papules, maculopapules, etc
Measured: Perioperative period
Arrhythmia
Rate of perioperative arrhythmia, especially tachycardia
Measured: Perioperative period
Specific symptoms
Rate of specific symptoms, including fatigue, sleepiness, dizziness, headache, stomach pain, constipation, nausea, dry mouth
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start20 Feb 2019
- Primary completion31 Jul 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Jia Shi, M.D., Study chair, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826004
- Sponsor's protocol ID
- Clemastine Pilot Study
- Status last verified
- Jan 2020
- First submitted
- 30 Jan 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Histamine H1 Receptor Antagonist Clemastine in Cardiovascular Surgery With Cardiopulmonary Bypass: A Pilot Study
- ClinicalTrials.gov ID
- NCT03826004
- Acronym / sponsor ID
- Clemastine Pilot Study
- Conditions
- Efficacy and Safety
- Keywords
- Cardiovascular Surgery, Histamine H1 Receptor Antagonist, Anaphylaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Saline SolutionSaline solution 2ml before anesthetic induction |
| Clemastine | Experimental | Drug: ClemastineClemastine fumarate 2mg/2ml before anesthetic induction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 years old
- Receiving selective cardiovascular surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
- Written informed consent obtained.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClemastineClemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle | Drug | Clemastine |
| Saline SolutionSaline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle | Drug | Placebo |
Primary outcome
Histamine concentration in plasma
Time frame: Perioperative period
Plasma histamine concentration evaluated by ELISA
5 secondary outcomes
Blood pressure
Time frame: Perioperative period
Airway pressure
Time frame: Perioperative period
Skin manifestation
Time frame: Perioperative period
Arrhythmia
Time frame: Perioperative period
Specific symptoms
Time frame: Perioperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Shi, M.D. study chair
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clemastine and Saline Solution in people with Efficacy and Safety, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histamine concentration in plasma (time frame: Perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.