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IRCT20250507065631N1 IRCT 2025-08-02 Mashhad University of Medical Sciences Comparing the effectiveness of intrapleural alteplase injection with intrapleural normal saline injection comparing the efficacy of intrapleural injection of alteplase with intrapleural infusion of normal saline through a chest tube in patients with parapneumonic effusion requiring drainage referred to Akbar Hospital 2025-08-01 anticipated 30 Complete https://irct.ir/trial/84927 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using random allocation software, a list of random blocks with variable sizes of 4 and 6 is designed, each block containing an equal number of groups, and a number is assigned to each block. The order of the contents of each group ensures a balanced allocation of individuals in the study groups. When each patient visits, one of the blocks is randomly selected and the patient is assigned to one of the groups according to the order of its contents, Blinding description: 1. Blinding of participants - Both types of drugs (intrapleural alteplase and intrapleural normal saline) are provided in identical containers (same brand, color, shape, and packaging). - Labels are marked only with random codes (e.g., A or B) and do not indicate the type of drug. - If the drugs have a different taste/smell, a neutral flavoring/color is used so that they are not distinguishable. 2. Blinding of investigators (drug prescribing team) - The research team does not have access to the randomization list (this list is managed by a pharmacist or a central system outside the team). - The drugs are pre-coded, and the investigator only gives the code (e.g., vial “A”) to the patient without knowing the contents. - In case of complications, reports are recorded without mentioning the treatment group. 3. Blinding of outcome assessors (data analysis team) - Samples are sent to the laboratory with numerical codes (not A/B). - The evaluators do not know which treatment group each sample belongs to. 3 Abscess of lung and mediastinum. Intervention 1: Intervention group: In patients in the intervention group, plasminogen (TPA), produced by Samen Pharmaceutical Company, will be injected into the pleural space at a dose of 0.1 mg per kilogram of weight, 3 times every eight hours for three days. Intervention 2: Control group: In the control group, normal saline, produced by Samen Pharmaceutical Company, will be injected into the pleural space at a rate of 0.1 mg per kilogram of weight, 3 times every eight hours for three days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The raw data from this study may be subject to misinterpretation without additional explanations (such as analysis protocol, codebook, or metadata). We prefer to publish the final results after controlled analyses. However, in case of urgent need and a formal request by the competent authorities (such as ethics committees or regulatory bodies), a re-examination will be possible.
public Parisan Omidvar
Akbar Children's Superspecialty Hospital, opposite Kaveh 14, Mashhad, Razavi Khorasan
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3871 3801 pari.san68124@gmail.com Mashhad University of Medical Sciences scientific Parisan Omidvar
Akbar Children's Superspecialty Hospital, opposite Kaveh 14, Mashhad, Razavi Khorasan
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3871 3801 pari.san68124@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Presence of pneumonia Pleural effusion no limit no limit Both Evidence of bleeding or bleeding disorder Pneumothorax Persistent leak from chest tube site Evidence of bronchopleural fistula Evidence of fibrinous septa and loculation on ultrasound or pleural paracentesis results with any of the following: lactate dehydrogenase greater than 1000, glucose less than 40, Gram stain fails to identify organism, frank pus J85 Abscess of lung and mediastinum Treatment - Drugs Placebo Intervention group: In patients in the intervention group, plasminogen (TPA), produced by Samen Pharmaceutical Company, will be injected into the pleural space at a dose of 0.1 mg per kilogram of weight, 3 times every eight hours for three days. Control group: In the control group, normal saline, produced by Samen Pharmaceutical Company, will be injected into the pleural space at a rate of 0.1 mg per kilogram of weight, 3 times every eight hours for three days. Recovery. Timepoint: After the intervention is completed. Method of measurement: Monitoring vital signs with a vital signs monitor, thermometer, blood pressure monitor, and pulse oximeter. Erythrocyte sedimentation rate. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Erythrocyte sedimentation rate test. CRP (C-reactive protein) test. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: It is performed using nephelometric or turbidometric methods in automated laboratory devices. CBC diff test (complete blood count with differential). Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Blood cell counting is performed using automated machines. Need for thoracotomy (open surgery) orminimally invasive surgery. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Imaging. Fever. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Thermometer. Respiratory distress. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Stopwatch. Oxygen level. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Pulse oximetry. Mashhad University of Medical Sciences Approved 2025-04-08 Ethics Committee of the Faculty of Medicine, Mashhad University of Medical Sciences Central Organization of Mashhad University of Medical Sciences, Knowledge and Health Town, between Al-Shahidi Square and Shahid Javan Square, end of Shahid Fakuri Boulevard, Mashhad, Khorasan Razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)