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RECRUITING Not applicable ClinicalTrials.gov

Prophylactic Anticoagulation for Central Venous Line Insertion in Critically Ill Children

Sponsor: Menoufia University • ClinicalTrials.gov ID: NCT07710482

Registry updated: 2026-10-07
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Description

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.

Interventions

  • Enoxaparin (Drug)
    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

Eligibility 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).

Conditions

Prophylactic Anticoagulation

Locations

  • Menoufia university hospital, Pediatric intensive care unit — Shibīn al Kawm, Menoufia Governorate, Egypt
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record