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Prophylactic Anticoagulation for Central Venous Line Insertion in Critically Ill Children

NCT07710482 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-24

No results posted yet for this study

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. 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.

Conditions

  • Prophylactic
  • Anticoagulation

Interventions

DRUG

Enoxaparin

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

Sponsors & Collaborators

  • Menoufia University

    lead OTHER

Principal Investigators

  • Hani Hamed Saad, MD, pediatrics · Faculty of medicine, Menoufia University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-07-31
Completion
2027-08-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07710482 on ClinicalTrials.gov