Assessment of TauroLock™ in port catheter
Phase 3
Recruiting
- Conditions
- Drugs used in chemotherapy.Chemotherapy session for neoplasmZ51.1
- Registration Number
- IRCT20201107049296N4
- Lead Sponsor
- Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
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
Exclusion Criteria
Having congenital coagulation disorder
Having non-tunneled Port-a-Cath
History of congenital hematologic disorders
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.