Preventing Catheter Problems with Prophylactic Enoxaparin in Critically Ill Children
Official title: Prophylactic Anticoagulation Versus Standard Care at Central Venous Line Insertion in Critically Ill Children: A Randomized Controlled Study
Run by Menoufia University · NCT07710482 · Data updated 2026-11-12
This study tests whether giving a small preventive dose of enoxaparin to kids with central venous lines in the PICU reduces line complications compared with standard care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Month to 18 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Menoufia University Academic / other |
| Locations | 1 site (Shibīn al Kawm, Menoufia Governorate) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | July 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07710482 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children in the PICU who require a newly placed central venous line (PICC or non-tunneled CVC).
✕Probably not a fit
Patients who do not experience catheter-related issues or who have higher bleeding risk may not benefit from prophylactic anticoagulation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized trial compares prophylactic enoxaparin to usual care in children requiring a central venous line in the PICU. Participants are randomized to receive prophylactic anticoagulation or standard care and followed for up to 30 days to assess catheter-related complications, bleeding, and infection. Outcomes include time to first catheter occlusion, rates of catheter-related thrombosis and CLABSI, number of catheter manipulations, dwell time, and need for thrombolysis or further anticoagulation. Data collection covers demographics, CVC characteristics, thrombotic events, anticoagulation details, laboratory tests, and imaging as clinically indicated. The study aims to inform whether prophylactic anticoagulation can improve catheter safety without unacceptable bleeding risk.
Why it matters
Potential benefit: If successful, the approach could reduce catheter-related complications and improve safety for children with central venous lines.
How similar studies have gone: Prior pediatric studies on prophylactic anticoagulation for CVCs have shown mixed results; this trial explores efficacy in a new clinical setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: * 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).
Where it's running
-
Menoufia university hospital, Pediatric intensive care unit
Shibīn al Kawm, Menoufia Governorate, Egypt Recruiting
Study contacts
- Principal investigator: Hani Hamed Saad, MD, pediatrics — Faculty of medicine, Menoufia University
- Study coordinator: Hani Hamed Saad, MD, Pediatrics
- Email: hani.hamed870@med.menofia.edu.eg
- Phone: +201067610619
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.