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IRCT20201107049296N4 IRCT 2023-10-22 Iran University of Medical Sciences Assessment of TauroLock™ in port catheter A comparison of the effect of taurolidine and 4 % citrate(TauroLock™-HEP500) and Heparin use in Port catheter on the function of catheter and prevention of catheter complications in children with malignancy 2023-10-07 anticipated 72 Complete https://irct.ir/trial/73054 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this study, we will use the stratified block randomization method to allocate patients into two groups, A and B, with a 1:1 ratio. The blocks will be of sizes 6 and 8 and will be stratified according to age. The age groups are 0-5 years, 5-9 years, 9-14 years, and 14-18 years. We will use www.sealedenvelope.com to provide the randomization. The information will be entered into the website in groups A and B, with a list length appropriate for the sample size and the previously mentioned stratification. The main researcher will receive the results once the allocation is complete, Blinding description: In this study, blinding was done only for the outcome assessor, the third collaborator of the project who reviews the patients' tests and clinical data without knowing the patient's allocation to a specific group. The Methodologist also analyses the data generally without knowing whether each data belongs to a specific group. 3 Drugs used in chemotherapy. Intervention 1: Intervention group: All patients have a single-lumen Polysite(Vygon) catheter. Catheters are used for the purposes of chemotherapy and the transfer of blood and serum products and other drugs. A bio-occlusive adhesive is also placed at the exit of the catheter from the skin, which is changed every three days, and the area will be disinfected with a Povidone-iodine solution. Based on the patient's clinical needs, port catheters are used after each treatment cycle in the intervention group from 2.5 to 3 cc of Taurolock™ solution (Taurolidine 1.35%/sodium cirate 4% Taurolock™, Tauropharm, Waldbuttelburn, Germany). Intervention 2: Control group: In the control group, all patients have single-lumen Polysite (Vygon) catheters. The catheters are used after being placed subcutaneously by a pediatric surgeon under standard and identical conditions for the purposes of chemotherapy and the transfer of blood and serum products and other drugs. According to the patient's clinical needs, the port catheters are diluted with 5 cc of heparin lock solution (5000 IU heparin/0.2 ml) Darou Pakhsh, Tehran, Iran, diluted up to 100 IU heparin/ml with 0.9% sterile normal saline after each treatment cycle. 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 There are no additional information.
public Aziz Egbali
Ali Asghar Children's Hospital, Zafar St, Modares Hwy
Tehran Iran (Islamic Republic of) ۱۹۱۹۸۱۶۷۶۶ +98 21 2222 2041 eghbali.a@iums.ac.ir Iran University of Medical Sciences scientific Aziz Eghbali
Aliasghar children’s hospital, Dastgerdi st., Zafar st., Tehran, Iran
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2268 8027 eghbali.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Children who have recently been diagnosed with malignancy requiring chemotherapy Children who need Port-a-Cath for treatment of malignancy, not only transfusion. Consent of patients' parents and implicit consent of children with decision-making capacity Children Aged between 1 month to 19 years 1 month 19 years Both Having congenital coagulation disorder Having non-tunneled Port-a-Cath History of congenital hematologic disorders Z51.1 Chemotherapy session for neoplasm Treatment - Drugs Treatment - Drugs Intervention group: All patients have a single-lumen Polysite(Vygon) catheter. Catheters are used for the purposes of chemotherapy and the transfer of blood and serum products and other drugs. A bio-occlusive adhesive is also placed at the exit of the catheter from the skin, which is changed every three days, and the area will be disinfected with a Povidone-iodine solution. Based on the patient's clinical needs, port catheters are used after each treatment cycle in the intervention group from 2.5 to 3 cc of Taurolock™ solution (Taurolidine 1.35%/sodium cirate 4% Taurolock™, Tauropharm, Waldbuttelburn, Germany). Control group: In the control group, all patients have single-lumen Polysite (Vygon) catheters. The catheters are used after being placed subcutaneously by a pediatric surgeon under standard and identical conditions for the purposes of chemotherapy and the transfer of blood and serum products and other drugs. According to the patient's clinical needs, the port catheters are diluted with 5 cc of heparin lock solution (5000 IU heparin/0.2 ml) Darou Pakhsh, Tehran, Iran, diluted up to 100 IU heparin/ml with 0.9% sterile normal saline after each treatment cycle Serum Interleukin-6 level. Timepoint: Before intervention, 1 month after entering the study and 6 month after entring. Method of measurement: Patients' serologic examinations; the serum IL-6 level will be measured in pg/dl. Duration of Port-a-Cath function. Timepoint: On the first medical contact and then every chemotherapy session or every month (whichever is earlier) up to 6 months. Method of measurement: The number of days that the port catheter has had a diagnostic or therapeutic function so that blood and fluids can move in both directions. Serum CRP level. Timepoint: At the beginning of the study the 1 month later and 6 months later. Method of measurement: Serum CRP level will be measured by serologic examinations. Iran University of Medical Sciences Approved 2023-10-07 Ethics committee of Iran University of Medical Sciences Iran university of medical science., Next to Milad Tower., Hemmat Highway., Tehran Tehran Tehran Iran (Islamic Republic of)