Recruiting
Phase 3

LMWH

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT02486666

Conditions

Venous Thromboembolism

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Enoxaparin

Study Details

Brief 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.

Conditions

Venous Thromboembolism

Study ID

NCT02486666

Start date

Mar, 2016

Status verified date

Oct, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Experimental Arm

Experimental Arm:patients will not have any dose titration regardless of anti-Xa level.

Premature neonates will receive enoxaparin 2.0 mg/kg/dose rounded to nearest whole mg twice daily, while term neonates will receive enoxaparin 1.7 mg/kg/dose rounded to nearest whole mg twice daily. Children≥1 month corrected age will receive 1.5 mg/kg/dose twice daily (maybe rounded +/- 10% for convenience of dosing) while children≥2 month corrected age will receive 1.0 mg/kg/dose twice daily (maybe rounded +/- 10% for convenience of dosing).

other: Control Arm

Control Arm: patients who will have dose titration based on anti-Xa levels to maintain a therapeutic range of 0.5-1.0 u/mL (standard of care).

Interventions

Enoxaparin

WEIGHT ADJUSTED FiXED DOSE OF LOW MOLECULAR WEIGHT HEPARIN (ENOXAPARIN) TO NEONATES AND CHILDREN WITH THROMBOSIS (FiXET)

Primary outcome measure

  • Feasibility of recruiting at least 5 subjects over the study period per center [ Time Frame: 12 - 24 months ]
  • Safety of administering a weight adjusted fixed dose of enoxaparin to neonates and children with thrombosis [ Time Frame: 12 - 24months ]

Central Contacts and Locations

Central contacts

Wenli Xie, MSc, CCRC

905-521-2100xiew@mcmaster.ca

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Isabella Mccary

215-590-0431MCCARYI@email.chop.edu

Principal Investigator:

Leslie Raffini, MD

IWK Health Center

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Zara Forbrigger

zara.forbrigger@iwk.nshealth.ca

Principal Investigator:

Ketan Kulkarni, MD

HHSC/McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8N3Z5

Contacts

Wenli Xie, MSc

905-521-2100xiew@mcmaster.ca

Principal Investigator:

Mihir Bhatt, MD

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Oct 15, 2021

Last verified

Oct, 2021

Keywords

  • Enoxaparin
  • thrombosis
  • neonate
  • children
  • RCT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2021-10-15.