Health Trials

Prophylactic Anticoagulation for Central Venous Line Insertion in Critically Ill Children

ConditionsProphylacticAnticoagulation
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: 1- Enoxaparin Group (Anticoagulation Arm)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of catheter-related venous thrombosis

Incidence (%) of catheter-related venous thrombosis within 14 days following central venous catheter placement, diagnosed using duplex ultrasonography. Both symptomatic thrombosis (clinically suspected and confirmed by imaging) and asymptomatic thrombosis (identified by protocol-specified ultrasound screening at Day 7-14) will be included. Outcome adjudication will be performed by an independent blinded committee.

Time frame
14 days

Secondary outcomes

1

Incidence of catheter patency

Percentage of participants with a functioning central venous catheter without need for replacement or fibrinolytic therapy at Day 7 and Day 14.

Time frame
Day 7 and Day 14
2

Percentage of participants who develop catheter-related bloodstream infection, diagnosed according to CDC criteria.

Percentage of participants who develop catheter-related bloodstream infection

Time frame
30 days
3

Incidence of major bleeding

Percentage of participants experiencing major bleeding within 14 days, defined as bleeding causing hemodynamic instability, requiring blood transfusion, surgical intervention, or resulting in intracranial hemorrhage.

Time frame
14 days
4

Incidence of minor bleeding

Percentage of participants experiencing minor bleeding not fulfilling criteria for major bleeding.

Time frame
14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Menoufia University

Lead sponsor

Source ClinicalTrials.gov
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