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IRCT20221230056992N1 IRCT 2023-12-18 Mashhad University of Medical Sciences Effect of topical tranexamic acid in the treatment of epistaxis Evaluation of the efficacy of topical tranexamic acid in the control of acute epistaxis 2023-12-06 anticipated 106 Complete https://irct.ir/trial/67880 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: There is no study assessing the effect of tranexamic acid nasal spray in the control of epistaxis in Iran, yet, Randomization description: It is prepared for the random assignment of random numbers with the help of 'randomization.com'. The opaque closed envelope method is used for random concealment. In this method, randomly assigned numbers are written in order and placed inside the envelope. The contents of the envelope will not be visible from the outside. For each patient, after entering the study and obtaining consent, an envelope is opened, and based on the envelope's contents, the individual is placed in the intervention or control group, Blinding description: Participants and care providers are blind due to the drug and placebo provide in the same color and matter, it is presented to them with "A" or "B" stickers. Data are also given to data analyser in the two forms of "A" or "B". 2-3 Haemorrhage from nose, Nosebleed. Intervention 1: Intervention group: Tranexamic acid ampule (100 mg/ml) is prepared as a nasal spray and its volume is 5cc given 5 puffs every 12 hours for 3 days. Intervention 2: Control group: Sodium chloride (0.9 percent) was prepared as a nasal spray with a volume of 5cc, prescribed 5 puffs every 12 hours for 3 days. Yes - There is a plan to make this available What will be shared: Title: "Data of participants in effects of TA on Epistaxis control study" All collected deidentified data (IPD) are accessible. When: Documents will be accessible one year after publishing. To whom: this is only available for people working in academic institutions. Conditions: It will only be presented for familiarization with the data collection process, and analysis of the data will not be permitted. Where to obtain: Applicant investigators could contact us with email addresses. How to obtain: The applicant will receive an email with the file containing the IPD within one month of requesting it. Comments:
public Mohamadreza Majidi
Ahmad Abad Ave, Ghaem Hospital, Mashhad
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3859 4082 majidiMR@mums.ac.ir Mashhad University of Medical Sciences scientific Mohamadreza Majidi
Ahmad Abad Ave, Ghaem Hospital, Mashhad
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3859 4082 majidiMR@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) patients with acute spontaneous epistaxis age more than 18 epistaxis is controlled with primary conservative management patient has a consent to enroll the study 18 years no limit Both sensitivity to tranexamic acid no consent to enroll the study there is any malignancy in the nasopharynx, nasal cavity or sinonasal tract prior packing in nasal cavities when come to ER pregnancy or breastfeeding history of coagulopathies hemodynamic instability second stage of hypertension (SBP>=160 and DBP>=100) epistaxis following trauma history of recent myocardial infarction or stroke renal dysfunction history of thromboembolism or seizure R04.0 Epistaxis Treatment - Drugs Treatment - Drugs Intervention group: Tranexamic acid ampule (100 mg/ml) is prepared as a nasal spray and its volume is 5cc given 5 puffs every 12 hours for 3 days. Control group: Sodium chloride (0.9 percent) was prepared as a nasal spray with a volume of 5cc, prescribed 5 puffs every 12 hours for 3 days. Number of patients without recurrent epistaxis during 7 days. Timepoint: first day, days 3 and 7 after intervention. Method of measurement: participants statement. Time to control bleeding. Timepoint: minutes to hours after intervention. Method of measurement: physical examination. Occurrence of side effects during 7 days. Timepoint: 7 days after intervention. Method of measurement: patient statement. Mashhad University of Medical Sciences Approved 2023-05-02 Ethics committee of Faculty of Medicine of Mashhad University of Medical Sciences East door of University Campus, Azadi square, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)