Comparison of the effect of heparinized normal saline flushing with prophylactic dose enoxaparin subcutaneous injection in the prevention of central venous catheter thrombosis in hospitalized high-risk patients
Determining effect of normal flushing of heparinized saline with subcutaneous injection of enoxaparin with a prophylactic dose in preventing central venous catheter thrombosis in high-risk patients admitted to Bahrami Hospital
Design
The current study is a phase 3 randomized clinical trial. Based on the determination of the sample size, 120 patients were included in the study and were divided into two equal groups using the Permuted Block Randomization method and the random table of numbers.
Settings and conduct
The study was conducted in the special care department of Bahrami Children's Hospital affiliated to Tehran University of Medical Sciences. Patients were divided into two equal groups of 60 people. After inserting the central venous catheter, the first intervention group included heparinized normal saline and the second intervention group received enoxaparin. At the beginning of the study, on the fourth day and one month after the study, the desired variables were measured.
Participants/Inclusion and exclusion criteria
The age of one month to 18 years; Patients with central venous catheter admitted to the intensive care unit; NO bleeding risk factors; Informed consent of the patient's parents or guardian to participate in study
Intervention groups
Group 1: Flushing 2 cc of heparinized normal saline every 8 hours after central venous catheter insertion.
Group 2: Subcutaneous injection of enoxaparin 0.5 mg/kg every 12 hours after central venous catheter insertion.
Main outcome variables
Thrombosis; Sepsis; Heart beat; Body temperature; Respiratory rate; Hemoglobin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230428058015N1
Registration date:2023-09-16, 1402/06/25
Registration timing:retrospective
Last update:2023-09-16, 1402/06/25
Update count:0
Registration date
2023-09-16, 1402/06/25
Registrant information
Name
Maryam Mohebbi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7754 7974
Email address
dr.m.mhb@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
2021-03-21, 1400/01/01
Actual recruitment end date
2022-03-21, 1401/01/01
Trial completion date
2022-08-23, 1401/06/01
Scientific title
Comparison of the effect of heparinized normal saline flushing with prophylactic dose enoxaparin subcutaneous injection in the prevention of central venous catheter thrombosis in hospitalized high-risk patients
Public title
Comparison of the effect of normal flushing of heparinized saline with subcutaneous injection of enoxaparin with a prophylactic dose in preventing central venous catheter thrombosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with central venous catheter admitted to the intensive care unit
None of the bleeding risk factors
Informed consent of the patient's parent or guardian to participate in the study
Age one month to 18 years
Exclusion criteria:
Risk factors of central venous catheter thrombosis
Anti-coagulant or anti-platelet medication use in the past 5 days
Major surgery in the last 24 hours
Glomerular filtration rate less than 30
Thrombocytopenia (platelets less than 50 thousand)
Kidney, heart and liver disorders
Uncontrolled blood pressure
Lumbar puncture in the last 24 hours
Age
From 1 month old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients divided into two groups using Permuted Block Randomization. In this way, the two-block modes (AB, BA) are randomly assigned to each treatment order using a random number table and the placement of the two blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Markazi Building, Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-04-29, 1400/02/09
Ethics committee reference number
IR.TUMS.CHMC.REC.1400.239
Health conditions studied
1
Description of health condition studied
Vein thrombosis
ICD-10 code
I81
ICD-10 code description
Portal vein thrombosis
Primary outcomes
1
Description
Thrombosis
Timepoint
At the beginning of the study, 4 and 30 days after the intervention
Method of measurement
ultrasound
2
Description
Sepsis
Timepoint
At the beginning of the study, 4 and 30 days after the intervention
Method of measurement
Patient symptoms based on systemic inflammatory response syndrome
3
Description
Heart rate
Timepoint
At the beginning of the study, 4 and 30 days after the intervention
Method of measurement
Arterial pulse taking
4
Description
Body Tempretute
Timepoint
At the beginning of the study, 4 and 30 days after the intervention
Method of measurement
Thermometer
5
Description
Respiration rate
Timepoint
At the beginning of the study, 4 and 30 days after the intervention
Method of measurement
observation
6
Description
Hemoglobin
Timepoint
At the beginning of the study, 4 and 30 days after the intervention
Method of measurement
ELISA Kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Flushing 2 cc of heparinized normal saline with a concentration of 2 units of heparin per cc every 8 hours after central venous catheter insertion.
Category
Treatment - Drugs
2
Description
Intervention group: Subcutaneous injection of enoxaparin at a dose of 0.5 mg/kg every 12 hours after central venous catheter insertion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahrami Pediatric Hospital
Full name of responsible person
Maryam Mohebbi
Street address
Bahrami Pediatric Hospital, Kiyaei St., Damavand St.
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7755 1584
Email
dr.m.mhb@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Mohebbi
Street address
Bahrami Pediatric Hospital, Kiyaei St., Damavand St.
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7756 8801
Email
dr.m.mhb@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Mohebbi
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Bahrami Pediatric Hospital, Kiyaei St., Damavand St.
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7756 8801
Email
dr.m.mhb@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Mohebbi
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Bahrami Pediatric Hospital, Kiyaei St., Damavand St.
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7756 8801
Email
dr.m.mhb@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Mohebbi
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Bahrami Pediatric Hospital, Kiyaei St., Damavand St.
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7756 8801
Email
dr.m.mhb@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data is shared after unidentifiable people
When the data will become available and for how long
Start accessing 6 months after printing results
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in congress as a scientific document
From where data/document is obtainable
Dr. Maryam Mohebbi by email:
dr.m.mhb@gmail.com
What processes are involved for a request to access data/document
As soon as the applicant requests to receive the documents, the data will be provided to them within two to three days
email: dr.m.mhb@gmail.com