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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

Protocol summary

Study aim
A comparison of the effect of taurolidine and ۴ % citrate and Heparin use in Port catheter on the function of catheter and prevention of catheter complications in children with malignancy
Design
Sampling in this study is convenience sampling method. This clinical trial has a control group, with parallel groups, single-blinded, non-randomized, phase 3 on 72 patients.
Settings and conduct
Sampling is collected from patients referred to the Oncology Department of Ali Asghar Hospital in Tehran. All patients have Polysite (Vygon) single lumen catheters . Based on clinical needs, After each treatment cycle, the patient's port catheters are filled with a solution of about 5 cc of heparin varnish in the first group, and in the second group, a solution of 2.5 to 3 cc of Taurolock solution is used.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: 1- Age between 1 month and 19 years 2- The need to have a port catheter for the purposes of chemotherapy for malignancies, not just transfusion of blood and blood products. 3-Informed consent Exclusion criteria: 1- Patients who are transferred to departments other than oncology 2- Patients who have hereditary coagulation disease. 3- Patients who have a non-tunneled Port catheter. 4- Patients who have hematological diseases without neutropenia (such as Diamond Blackfan anemia and sickle cell anemia).
Intervention groups
In the intervention group, which includes 38 patients, after each cycle of chemotherapy, the catheter port is filled with 5 cc of Tauoolock solution. In the control group, which includes 38 patients, after the end of each chemotherapy, after washing the Port Catheter with normal saline, they will be varnished with a sufficient amount of Heparin solution.
Main outcome variables
This study measures the function of the catheter during the 6 months. ; inflammatory markers: including IL-6, Total WBC, CRP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201107049296N4
Registration date: 2023-10-22, 1402/07/30
Registration timing: registered_while_recruiting

Last update: 2023-10-22, 1402/07/30
Update count: 0
Registration date
2023-10-22, 1402/07/30
Registrant information
Name
Aziz Eghbali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2268 8027
Email address
eghbali.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-01-30, 1402/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Assessment of TauroLock™ in port catheter
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 1 month old to 19 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran university of medical science., Next to Milad Tower., Hemmat Highway., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-10-07, 1402/07/15
Ethics committee reference number
IR.IUMS.REC.1402.598

Health conditions studied

1

Description of health condition studied
Drugs used in chemotherapy
ICD-10 code
Z51.1
ICD-10 code description
Chemotherapy session for neoplasm

Primary outcomes

1

Description
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

2

Description
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 outcomes

1

Description
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.

Intervention groups

1

Description
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).
Category
Treatment - Drugs

2

Description
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
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tَehran Ali Asghar Children's Hospital
Full name of responsible person
Aziz Eghbali
Street address
Ali Asghar Children's Hospital, Zafar St, Modares Hwy
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2304 6413
Email
eghbali.a@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, East Hemmat Expressway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 3248
Email
falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Aziz Egbali
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Ali Asghar Children's Hospital, Zafar St, Modares Hwy
City
Tehran
Province
Tehran
Postal code
۱۹۱۹۸۱۶۷۶۶
Phone
+98 21 2222 2041
Email
eghbali.a@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Aziz Eghbali
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Aliasghar children’s hospital, Dastgerdi st., Zafar st., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2268 8027
Fax
Email
eghbali.a@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Aziz Eghbali
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Aliasghar children’s hospital, Dastgerdi st., Zafar st., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2268 8027
Fax
Email
eghbali.a@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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