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IRCT20211121053138N1 IRCT 2021-12-01 Mashhad University of Medical Sciences The evaluation of the effect of intravenous Tranexamic acid in external DCR (Dacryocyctorhinostomy) The evaluation of the effect of intravenous Tranexamic acid in reducing the amount of bleeding during external DCR (Dacryocyctorhinostomy) in patients with nasolacrimal duct obstruction ( NLDO) compared to control group 2021-12-21 anticipated 70 Complete https://irct.ir/trial/60230 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: Randomization of the structure will be performed using the sequence generated by PASS statistical software. The generated sequences are placed in closed envelopes in order so that their contents are not visible from the outside and an envelope will be allocated for each patient who agrees to participate in the project, respectively. Eventually the patient will be randomly placed in the control or intervention group, Blinding description: The study will be double blind. Impact assessor will be blinded to type intervention and the researcher who must enter the data into the checklist will be blinded to the type of intervention. 3 nasolacrimal duct obstruction. Intervention 1: Intervention group: Tranexamic acid will be injected intravenously only once, at a dose of 10 mg per kilo, half an hour before surgery. The manufacturer of the drug is CASPIAN TAMIN. Intervention 2: Control group: no placebo will be injected. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more information
public Samaneh Gholamhosseinpour-Omran
No. 53 Beheshti Ave
Mashhad Iran (Islamic Republic of) 9175914785 +98 51 3844 0459 gholamhoseinpoursamaneh@gmail.com Mashhad University of Medical Sciences scientific Samaneh Gholamhosseinpour-Omran
No. 53 Beheshti Ave
Mashhad Iran (Islamic Republic of) 9175914785 +98 51 3844 0459 gholamhoseinpoursamaneh@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) patients with nasolacrimal duct obstruction 18 years no limit Both Any history of trauma to lacrimal drainage system History of coagulopathy state History of bleeding disorders History of Covid-19 in the last 6 months H0405 Stenosis and insufficientcy of lacrimal passages Treatment - Drugs Treatment - Drugs Intervention group: Tranexamic acid will be injected intravenously only once, at a dose of 10 mg per kilo, half an hour before surgery. The manufacturer of the drug is CASPIAN TAMIN Control group: no placebo will be injected. Record the amount of intraoperative bleeding at external dacryocyctorhinostomy. Timepoint: at the end of surgery. Method of measurement: The amount of bleeding recorded by a standard suction device in a calibrated tank. Mashhad University of Medical Sciences Approved 2021-11-01 Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences No. 53 Beheeshti Ave, Kohsangi Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)