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Clemastine in Cardiovascular Surgery

NCT03826004 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-01-13

No results posted yet for this study

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.

Conditions

  • Efficacy and Safety

Interventions

DRUG

Clemastine

Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle

DRUG

Saline Solution

Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    lead OTHER

Principal Investigators

  • Jia Shi, M.D. · Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2019-07-31
Completion
2020-01-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03826004 on ClinicalTrials.gov