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Assessment of the efficacy and safety of antimicrobial lock solution of Ethanol-enoxaparin for the prevention of catheter-related infection in hematologic patients: A randomized, controlled, triple-blind clinical trial

Protocol summary

Study aim
Assessment of the efficacy and safety of ethanol-enoxaparin lock solution in preventing catheter-related bloodstream infections in central venous catheters
Design
"A clinical trial with a control group, parallel groups, triple-blind, randomized, conducted in phases 2 and 3, involving 402 patients."
Settings and conduct
This study is a randomized, triple-blind (patient, researcher, statistical analyst) phase 2 and 3 clinical trial that will be conducted in the hematology and stem cell transplant units of Shariati Hospital. After obtaining informed consent, patients will be randomly assigned to either the intervention (ethanol/enoxaparin) or control group (normal saline). The lock solution will be administered intraluminally by the ward nurse for a minimum of 2 hours per lumen per day throughout the study period (from 24 to 48 hours after catheter insertion until catheter removal or occurrence of CLABSI).
Participants/Inclusion and exclusion criteria
The study will include patients in the hematology and hematopoietic stem cell transplant units who are over 18 years old and have had a central venous catheter inserted within the last 48 hours, provided they do not have an active systemic infection and have no history of sensitivity to ethanol, enoxaparin or seizures.
Intervention groups
Patients meeting the study criteria will be randomly assigned to either the drug or placebo group. Participants will receive either ethanol/enoxaparin solution (40% volume/volume ethanol and 1000 units of enoxaparin per cc) or normal saline as catheter lock solution for at least 2 hours per lumen per day. Following this, the lock solution will be removed. The catheter will also be flushed with 10 mL of normal saline before and after locking.
Main outcome variables
The occurrence of catheter-related bloodstream infection, catheter colonization, and the safety and tolerance of ethanol/enoxaparin lock solution.

General information

Reason for update
Acronym
E-LOCK
IRCT registration information
IRCT registration number: IRCT20220618055207N2
Registration date: 2024-03-20, 1403/01/01
Registration timing: prospective

Last update: 2024-03-20, 1403/01/01
Update count: 0
Registration date
2024-03-20, 1403/01/01
Registrant information
Name
khadije delroba
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6659 7316
Email address
delrobakh88@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2025-03-18, 1403/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the efficacy and safety of antimicrobial lock solution of Ethanol-enoxaparin for the prevention of catheter-related infection in hematologic patients: A randomized, controlled, triple-blind clinical trial
Public title
Investigating the effect of ٍٍEthanol- Enoxaparin lock in preventing catheter-related infections
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥ 18 Hematologic malignancy or hematopoietic stem cell transplantation Recent insertion of the catheter (within the last 48 hours) in aseptic conditions of the operating room, and confirmation of its placement through radiography or radioscopy Informed consent from the patient or their legal guardian
Exclusion criteria:
History of any allergy/sensitivity/intolerance to Ethanol or Enoxaparin Pregnancy or breastfeeding History of alcohol abuse History of thrombocytopenia caused by heparin (HIT) or having an active hypocoagulable state Evidence of catheter site infection Evidence of active systemic infection (fever, chills, positive culture and leukocytosis) or documented bacteremia within 24 hours before catheter placement Receiving antibiotic treatment Patients in need of dialysis modalities Cirrhosis of the liver Having a history or documented active seizure disorder Patients whose catheters are placed in emergency situations Patients in critical conditions (those who need continuous infusion of fluid/medicine through both lumens)
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 402
Randomization (investigator's opinion)
Randomized
Randomization description
Study randomization: The Balanced Blocked Randomization method and Stata software will be used for randomization. Random allocation will be carried out using blocks of size 2 to 12. The total sample size is estimated to be 402 patients. Therefore, using the ralloc module (Random allocation of treatments in controlled trials) in Stata software, random samples will be determined for the study. Implementation of randomization: The randomization sequence will be prepared by a statistician who is not involved with the patients. Researchers at the center and participants will be unaware of the study sequence. Upon confirmation of a new patient's entry into the study and registration of the patient's code, the coordinator stationed at the patient site will assign the patient to one of the study groups based on the specified randomization sequence.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Due to the detectable smell of Ethanol, it is difficult for the ward nurse to blind the lock solutions even with a mask. Therefore, the study will be conducted in a triple-blind manner for the patient, the researcher, and the data analyst.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institute of Pharmaceutical Sciences, Tehran University of Medical Sciences (Research Ethics Committ
Street address
13th floor, block A, Treatment and Medical Education headquarters, Ministry of Health., Simaye Iran Ave., West Quds town
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.190

Health conditions studied

1

Description of health condition studied
Central-line-associated bloodstream infection
ICD-10 code
T80.21
ICD-10 code description
Infection due to central venous catheter

2

Description of health condition studied
Catheter-related thrombosis
ICD-10 code
T82.8
ICD-10 code description
Other specified complications of cardiac and vascular prosthetic devices, implants and grafts

Primary outcomes

1

Description
Incidence rate of catheter-related bloodstream infection (CLABSI)
Timepoint
From the beginning of the study until the time of catheter removal
Method of measurement
A positive catheter culture result is considered semiquantitative if there are more than 15 colony-forming units (cfu) per catheter segment or quantitative if there are more than 10^2 cfu per catheter segment when the organism reported from the catheter culture matches that of a peripheral blood culture. Additionally, it is considered positive if simultaneous quantitative blood cultures show a ratio of more than 3:1 cfu/ml (catheter versus peripheral blood), or if growth in a blood culture obtained through a hub catheter is detected by an automated blood culture system at least 2 hours earlier than a simultaneous peripheral blood culture of an equal volume.

2

Description
Incidence rate of central venous catheter colonization
Timepoint
Once a week until the catheter is removed
Method of measurement
Swab culture from the inner surfaces of catheter hubs

3

Description
Safety and tolerance of ٍEthanol-Enoxaparin lock solution
Timepoint
Daily from the beginning to the end of the study
Method of measurement
Presenting Complaint and Physical Examination and Some laboratory tests such as liver enzyme tests

Secondary outcomes

1

Description
Incidence rate of central venous catheter thrombosis
Timepoint
Daily, throughout the duration of the study.
Method of measurement
Examining the catheter insertion site and, if clinically indicated, performing ultrasound.

2

Description
The occurrence rate of catheter mechanical damage
Timepoint
Daily, throughout the duration of the study.
Method of measurement
Catheter physical examination

3

Description
Rate of central venous catheter withdrawal due to infection, thrombosis, or mechanical damage
Timepoint
Daily, throughout the duration of the study.
Method of measurement
Daily visit

4

Description
Duration of patient hospitalization
Timepoint
Daily, throughout the duration of the study.
Method of measurement
Daily visit

5

Description
Mortality rate
Timepoint
Daily, throughout the duration of the study.
Method of measurement
daily visit

Intervention groups

1

Description
Intervention Group: A lock solution containing 40% volume-volume Ethanol and 1000 units of Enoxaparin per cc (manufactured by Poish Daru Products Company) will be administered intraluminally by the ward nurse for at least 2 hours per day for each lumen during the study period (from 24 to 48 hours after catheter insertion until catheter removal or occurrence of CLABS).During intervals when the catheter lumens are not in use based on the patient's medication schedule, the catheter will first be flushed with at least 10 cc of 0.9% NaCl solution. Then, approximately 2.5 ml of the lock solution will be slowly injected into each lumen using a syringe, and the lumen will be capped with sterile gauze and dressing to prevent unintended use.If the catheter needs to be reused, the lock solution should be aspirated first, followed by flushing with 10 cc of 0.9% NaCl solution. For double-lumen catheters, one lumen will be locked while the other is used for medication and fluid administration. The process will then be repeated for the other lumen after aspiration of the lock solution.
Category
Prevention

2

Description
Control Group: Normal saline will be used intraluminally by the ward nurse in the control group for at least 2 hours per day for each lumen during the study period (from 24 to 48 hours after catheter insertion until catheter removal or occurrence of CLABS).During intervals when the catheter lumens are not in use based on the patient's medication schedule, the catheter will first be flushed with at least 10 cc of 0.9% NaCl solution. Then, approximately 2.5 ml of the lock solution will be slowly injected into each lumen using a syringe, and the lumen will be capped with sterile gauze and dressing to prevent unintended use. If the catheter needs to be reused, the lock solution should be aspirated first, followed by flushing with 10 cc of 0.9% NaCl solution. For double-lumen catheters, one lumen will be locked while the other is used for medication and fluid administration. The process will then be repeated for the other lumen after aspiration of the lock solution.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Institute for Oncology, Hematology and Cell Therapy., Shariati hospital
Full name of responsible person
bita shahrami
Street address
Shariati hospital., north kargar
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8800 4140
Fax
+98 21 8822 4140
Email
horcbmt@sina.tums.ac.ir
Web page address
https://riohct.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Akbari Sari
Street address
6th floor of Research and Technology Vice-Chancellor, Central Organization of the University., corner of Quds St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
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
20
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

2

Sponsor
Name of organization / entity
Pooyesh Darou Biopharmaceuticals company
Full name of responsible person
Mojtaba Tabatabayi Yazidi
Street address
NO. 13, 5th Ave, Fatemi St
City
Tehran
Province
Tehran
Postal code
1415763863
Phone
+98 21 8899 7248
Fax
+98 21 8896 9368
Email
info@pooyeshdarou.com
Web page address
https://pooyeshdarou.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pooyesh Darou Biopharmaceuticals company
Proportion provided by this source
80
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Amir Ahmad Arabzadeh
Position
Associate Professor of Vascular Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Daneshga St. Ardabil Complex University
City
Ardabil
Province
Ardabil
Postal code
85991-56189
Phone
+98 45 3353 4790
Fax
+98 45 3353 4773
Email
amir_medico@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bita Shahrami
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, 2nd floor, College of Pharmacy, Tehran University of Medical Sciences., 16th Azar St., Enghelab Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6695 4709
Fax
+98 21 4293 3261
Email
bita.shahrami@gmail.com
Web page address
https://cv.tums.ac.ir/cv/Bita_Shahrami

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadije Delroba
Position
Ph.D
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, 2nd floor, College of Pharmacy, Tehran University of Medical Sciences., 16th Azar St., Enghelab Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6695 4709
Fax
Email
delrobakh88@yahoo.com

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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