Prophylactic Anticoagulation for Central Venous Line Insertion in Critically Ill Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorMenoufia University
About this trial
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.
Eligibility criteria
Qualifiers
All Children requiring a newly placed central venous line (peripherally inserted central catheter [PICC], or non-tunneled central venous catheter) for clinical care.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Enoxaparin
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov