drugset / Trial / NCT07710482

Prophylactic Anticoagulation for Central Venous Line Insertion in Critically Ill Children

NCT07710482

Not yet recruiting 40 enrolled Menoufia University
NaSingle-groupOpen-labelPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Enoxaparin sodium Other / unclassified 0.5 mg/kg Subcutaneous
Comparator Enoxaparin sodium Other / unclassified 0.75 mg/kg Subcutaneous

Indications

No indication recorded.