Pilot Feasibility and Safety of Administering Weight Adjusted Fixed LMWH Dose
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborators:
Children's Hospital of Eastern Ontario Children's Hospital of Philadelphia IWK Health Centre