Evaluation of the effect of inhaled Tranexamic acid in controlling symptoms and clinical improvement and outcome of patients with moderate and severe hemoptysis
Design
Clinical trials with control group, double blind, randomized blocks in 80 patients (two groups of 40)
Settings and conduct
All patients with moderate and severe hemoptysis over 15 years of age who are admitted to Emergency department of Imam Khomeini Hospital are included.Computerized randomization method gives each patient a special code (which is related to medicine or placebo). The appearance of the drug and placebo is completely identical and the patient and physician will be unaware of the substance content that is prescribed. The medication or placebo is nebulized in 4 doses at intervals of 12 hours for the patient, and then the information about the volume and frequency of hemoptysis and the need for invasive interventions and the duration of hospitalization are recorded and analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients over 15 years old with moderate to severe hemoptysis referring to the emergency department.
Exclusion criteria: history of allergy, active thromboembolic disease, lack of consent to participate in the study
Intervention groups
After obtaining patients' consent to enter the study, parallel to the usual treatments for control of symptoms in patients in the case group, 500 mg (5 cc) of Tranexamic Acid was administered by nebulizer and in 4 doses, and in the control group 5 cc distilled water Will not be prolonged. The results of this study included: volume and frequency of hemoptysis, the amount of invasive interventions in the two groups and the final outcome of the treatment of patients
Main outcome variables
Frequency of hemoptysis, volume of hemoptysis, the need for invasive interventions, duration of admission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170313033051N2
Registration date:2019-03-30, 1398/01/10
Registration timing:prospective
Last update:2019-03-30, 1398/01/10
Update count:0
Registration date
2019-03-30, 1398/01/10
Registrant information
Name
Mohammad Afzalimoghaddam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6690 4848
Email address
afzalimoghadam@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-19, 1398/01/30
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of administration of nebulized Tranexamic Acid in control of symptoms and outcome of patients with moderate and severe hemoptysis
Public title
Impact of nebulized Tranexamic Acid in control of hemoptysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate and severe hemoptysis
Age above 15 years old
Exclusion criteria:
History of allergy to Tranexamic Acid
Active thromboembolic event
lack of consent to participate in the study
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Patients are randomly divided into two groups of cases and controls, and after assigning the code (drug or placebo) to each patient, the administration will be done in double blinded method (physician and patient).
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, patient care physicians and outcome evaluators do not inform that administered drug is Tranexamic Acid or placebo and only the researcher is aware of the type of prescribing drug. During the analysis of the data, it is determined which participant has received the medication and which placebo.
Placebo
Used
Assignment
Parallel
Other design features
1- Administration of nebulized Tranexamic Acid 2- Using the randomization method 3- The double blindness of the study 4- The number of sample size in comparison with other studies
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tehran University of Medical Sceinces