Pilot Feasibility and Safety of Administering Weight Adjusted Fixed LMWH Dose

Status unconfirmed · Phase 3

Conditions studied: Venous Thromboembolism

In brief

Background Enoxaparin is a commonly used low molecular weight heparin (LMWH) for the treatment of neonatal and children thrombosis that is monitored with anti-factor Xa (anti-Xa) levels. However, this therapeutic range of anti-Xa (0.5 - 1.0 u/ml) was extrapolated from adult studies. The burden of pain to neonates due to venipunctures and of resources to the health care system also warrants an evidence-based review to assess the utility of monitoring LMWH therapy with anti-Xa levels. Methods/Design This is a prospective pilot, feasibility and safety multicenter, randomized controlled trial to compare the approach of treating thrombosis in neonates and children with enoxaparin using weight adjusted fixed dose to variable dose titrated to maintain a pre-determined anti-Xa range (0.5-1.0 u/mL). We plan to recruit 20 neonates and children over the study period, who will be randomized within their first week of anti-coagulation treatment. Key feasibility outcomes include screening/recruitment ratio, monthly recruitment rate, and completeness of data collection. We will also measure the safety outcome of bleeding as well as comment on efficacy of resolution of thrombosis as a secondary outcome. Discussion The administration of weight adjusted fixed dose of enoxaparin without anti-Xa monitoring has the potential to reduce pain from multiple venipunctures in neonates and children as well as resources used in their already complex care. The results of the FiXET trial will set the framework for a larger multicenter randomized controlled trial to compare the efficacy of administering enoxaparin to neonates and children without monitoring to the current conventional approach of routine monitoring with anti-Xa levels.

Key facts

Study ID

NCT02486666

Run by

Hamilton Health Sciences Corporation

People needed

20

Starts

2016-03-01

Expected to finish

2022-12-01

Last updated by the study team

2021-10-15

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Birth to under 18 years of age at the diagnosis of thrombosis event
• Diagnosis of deep vein thrombosis confirmed by either venography or ultrasound, pulmonary embolism confirmed by ventilation perfusion scan or spiral CT scan or pulmonary angiogram, clinically stable cerebral sinovenous thrombosis confirmed with magnetic resonance imaging, or cardiac thrombosis diagnosed by echocardiogram.
• The treating team has decided to initiate anti-coagulation therapy

You may not qualify if…

• Platelet count < 50x109/L;
• Hemorrhage or high risk of bleeding with the use of anticoagulation therapy;
• Creatinine > 1.5x upper limit of normal;
• Liver dysfunction associated with coagulopathy leading to a clinically relevant bleeding risk;
• Documented history of heparin induced thrombocytopenia;
• Known contraindication to heparin

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• IWK Health Center — Halifax, Nova Scotia, Canada (enrolling)
• HHSC/McMaster Children's Hospital — Hamilton, Ontario, Canada (enrolling)
• Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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