Prophylactic Anticoagulation for Central Venous Line Insertion in Critically Ill Children

July 13, 2026 updated by: Hani Hamed Saad, Menoufia University

Prophylactic Anticoagulation Versus Standard Care at Central Venous Line Insertion in Critically Ill Children: A Randomized Controlled Study

This will be a Prospective, randomized, open- label, parallel-group, center trial, which will include 80 of Children which will be admitted at Pediatric Intensive Care Unit (PICU) of Menoufia university Hospital from August 2026 to Mars 2027.

Aim of the study will be:

  1. Compare the incidence of clinically significant catheter-related complications (catheter occlusion requiring intervention or catheter-related thrombosis) within 14 days after CVL insertion between children receiving prophylactic anticoagulation and those receiving standard care.
  2. Compare time-to- first catheter occlusion.
  3. Compare rate of catheter-related bloodstream infection (CLABSI) within 30 days.
  4. Compare number of catheter manipulations and unplanned catheter removals.
  5. Compare major and minor bleeding events.
  6. Assess catheter dwell time and need for thrombolysis or therapeutic anticoagulation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study population will be divided into two groups:

  1. Enoxaparin Group (Anticoagulation Arm):

    This group will receive prophylactic anticoagulation with enoxaparin in accordance with institutional guidelines for prophylactic anticoagulation in Pediatric patients.

  2. Usual Care Group (Control Arm):

This group will receive standard care without prophylactic anticoagulation.

All patients in this study will be subjected to:

A- Demographic and clinical data Collection:

  • Patient demographics: age, sex, body mass index (BMI) and the primary diagnosis.
  • CVC characteristics: type of line, number of lumens, catheter size, site and laterality, and date of insertion and removal.
  • Thrombotic events: date of thrombus detection, affected blood vessel (confirmed by Doppler ultrasound), and anticoagulation details (type, dose, and duration. (
  • Anticoagulant use: agent used (e.g., LMWH), initiation timing and monitoring. B- Full clinical examination will be done including vital signs (HR, RR, BP, temperature) for each child.

C- Investigations will be done including the following:

Laboratory Analysis: CBC, Platelet counts at baseline, day 3-5, for monitoring heparin- related thrombocytopenia, CRP, Electrolytes, Blood culture, Urea, creatinine, ALT, AST and D-dimer level.

Radiological: Ultrasound of catheterized vessel if clinical suspicion of thrombosis; consider scheduled ultrasound on day 7 and 14.

Intervention and Monitoring

Enoxaparin Group (Intervention Arm):

  • Children randomized to receive enoxaparin will be administered enoxaparin subcutaneously every 12 hours, with dosing based on age and weight as follows:

    1. 0.75mg/kg for children ≤2 months old.
    2. 0.5 mg/kg (maximum 30 mg) for children >2 months old.
  • Doses will be adjusted for obesity and renal insufficiency as needed.
  • The first dose will be given within 24 hours of CVC insertion. The dose will be adjusted to achieve a target anti-Xa level of 0.2-0.5 IU/mL.
  • Anti-Xa levels will be measured locally 4-6 hours after every third dose, and dosing will be adjusted accordingly until the target range is reached. Once therapeutic range is achieved, anti-Xa monitoring will be performed weekly.
  • Enoxaparin will be discontinued in the event of a clinically significant bleeding episode. It will be resumed 24 hours after correction of any coagulopathy, as confirmed by clinical and laboratory parameters.

Usual Care Group (Control Arm):

Children randomized to usual care will not receive anticoagulation. Standard CVC care procedures will be followed according to PICU protocols.

Monitoring for Thrombosis and Bleeding

  1. All children will undergo daily clinical monitoring for signs of bleeding.
  2. To evaluate catheter-related thrombosis, ultrasound imaging of the vein proximal and distal to the CVC insertion site.

  3. To assess coagulation profile and thrombotic risk, blood samples will be drawn at the following time points:

    1. On the day of CVC insertion
    2. The day after insertion
    3. Day 4 after insertion

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Nagwan Yossery Saleh, MD, Pediatrics
  • Phone Number: +201003961071
  • Email: drnagwan80@gmail.com

Study Locations

  • Egypt
    • Menoufia Governorate
      • Shibīn al Kawm, Menoufia Governorate, Egypt
        • Menoufia university hospital, Pediatric intensive care unit
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Nagwan Yossery Saleh, MD, pediatrics
        • Sub-Investigator:
          • Amira Zaki Badawy, MD, clinical pathology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1)- All Children requiring a newly placed central venous line (peripherally inserted central catheter [PICC], or non-tunneled central venous catheter) for clinical care.

Exclusion Criteria:

  1. - Known major congenital bleeding diathesis or platelet count <50,000/µL at time of insertion.
  2. - Already on therapeutic anticoagulation for another indication.
  3. - Known heparin allergy or history of heparin-induced thrombocytopenia.
  4. - Use of dialysis catheters (study focuses on standard CVCs/PICCs).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 1- Enoxaparin Group (Anticoagulation Arm)
This group will receive prophylactic anticoagulation with enoxaparin in accordance with institutional guidelines for prophylactic anticoagulation in Pediatric patients.
Drug: This group will receive prophylactic anticoagulation with enoxaparin in accordance with institutional guidelines for prophylactic anticoagulation in Pediatric patients.

Enoxaparin Group (Intervention Arm):

This group will receive prophylactic anticoagulation with enoxaparin in accordance with institutional guidelines for prophylactic anticoagulation in Pediatric patients.

  • Children randomized to receive enoxaparin will be administered enoxaparin subcutaneously every 12 hours, with dosing based on age and weight as follows:

    1. 0.75mg/kg for children ≤2 months old.
    2. 0.5 mg/kg (maximum 30 mg) for children >2 months old. Doses will be adjusted for obesity and renal insufficiency as needed.
  • The first dose will be given within 24 hours of CVC insertion. The dose will be adjusted to achieve a target anti-Xa level of 0.2-0.5 IU/mL.
  • Anti-Xa levels will be measured locally 4-6 hours after every third dose, and dosing will be adjusted accordingly until the target range is reached. Once therapeutic range is achieved, anti-Xa monitoring will be performed weekly.
  • Enoxaparin will be discontinued in the event of a clinically significant bleeding episode. I

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of catheter-related venous thrombosis
Time Frame: 14 days
Incidence (%) of catheter-related venous thrombosis within 14 days following central venous catheter placement, diagnosed using duplex ultrasonography. Both symptomatic thrombosis (clinically suspected and confirmed by imaging) and asymptomatic thrombosis (identified by protocol-specified ultrasound screening at Day 7-14) will be included. Outcome adjudication will be performed by an independent blinded committee.
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of catheter patency
Time Frame: Day 7 and Day 14
Percentage of participants with a functioning central venous catheter without need for replacement or fibrinolytic therapy at Day 7 and Day 14.
Day 7 and Day 14
Percentage of participants who develop catheter-related bloodstream infection, diagnosed according to CDC criteria.
Time Frame: 30 days
Percentage of participants who develop catheter-related bloodstream infection
30 days
Incidence of major bleeding
Time Frame: 14 days
Percentage of participants experiencing major bleeding within 14 days, defined as bleeding causing hemodynamic instability, requiring blood transfusion, surgical intervention, or resulting in intracranial hemorrhage.
14 days
Incidence of minor bleeding
Time Frame: 14 days
Percentage of participants experiencing minor bleeding not fulfilling criteria for major bleeding.
14 days
Catheter removal due to thrombosis
Time Frame: 30 days
Percentage of participants requiring catheter removal because of confirmed catheter-related thrombosis.
30 days
Catheter dwell time
Time Frame: 30 days
Duration of central venous catheter placement measured in days from insertion until catheter removal.
30 days
All-cause in-hospital mortality
Time Frame: During hospitalization (up to 30 days)
Percentage of participants who die from any cause during hospitalization.
During hospitalization (up to 30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Menoufia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hani Hamed Saad, MD, pediatrics, Faculty of medicine, Menoufia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1/2026 PEDI 26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prophylactic Anticoagulation

Clinical Trials on This group will receive prophylactic anticoagulation with enoxaparin in accordance with institutional guidelines for prophylactic anticoagulation in Pediatric patients.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings