Prophylactic Anticoagulation for Central Venous Line Insertion in Critically Ill Children

NCT07710482 | Not Yet Recruiting DMC

• 1 other identifier: 1/2026 PEDI 26
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Compare time-to- first catheter occlusion.
3. 3.Compare rate of catheter-related bloodstream infection (CLABSI) within 30 days.
4. 4.Compare number of catheter manipulations and unplanned catheter removals.
5. 5.Compare major and minor bleeding events.
6. 6.Assess catheter dwell time and need for thrombolysis or therapeutic anticoagulation.

Conditions

Prophylactic; Anticoagulation

Keywords

Prophylactic; Anticoagulation; Central; venous; line; Insertion; critically; ill; childern; Randomized; Controlled; Study

Outcome Measures

Primary Outcomes (1)

• Incidence of catheter-related venous thrombosis

  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 Outcomes (7)

• Incidence of catheter patency

  Day 7 and Day 14

• Percentage of participants who develop catheter-related bloodstream infection, diagnosed according to CDC criteria.

  30 days

• Incidence of major bleeding

  14 days

• Incidence of minor bleeding

  14 days

• Catheter removal due to thrombosis

  30 days

Study Arms (1)

1- Enoxaparin Group (Anticoagulation Arm)

ACTIVE COMPARATOR

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

Drug: Enoxaparin

Interventions

Enoxaparin DRUG

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

1- Enoxaparin Group (Anticoagulation Arm)

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia university hospital, Pediatric intensive care unit

Shibīn al Kawm, Menoufia Governorate, Egypt

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Hani Hamed Saad, MD, pediatrics

  Faculty of medicine, Menoufia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hani Hamed Saad, MD, Pediatrics

CONTACT

+201067610619; hani.hamed870@med.menofia.edu.eg

Nagwan Yossery Saleh, MD, Pediatrics

CONTACT

+201003961071; drnagwan80@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pediatrics at Faculty of medicine , Menoufia university

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

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)