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Prophylactic Anticoagulation for Central Venous Line Insertion in Critically Ill Children

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study description expanded, about 19 words
    • Eligibility criteria expanded, about 5 words
  2. Recruitment opened
    • Site details revised
    v3
  3. Interventions: This group will receive prophylactic anticoagulation with enoxaparin in accordance with institutional guidelines for prophylactic… to Enoxaparin (Drug)
    • Eligibility criteria shortened, about 5 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07710482
Lead Sponsor Menoufia University
Conditions
(from sponsor)		 Prophylactic, Anticoagulation
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov