A Retrospective Chart-Review Study to Evaluate the Safety, Effectiveness and Dosing of Dalteparin for Treatment of Venous Thromboembolism (VTE) in Neonates

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive study

Study drug and medical condition

• Name of medicine, other:
  Fragmin
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AB04) dalteparin

  dalteparin
• Medical condition to be studied:
  Embolism venous

Population studied

• Short description of the study population:
  The study population involved neonates aged ≤ 28 days exposed to dalteparin for the treatment of venous thromboembolism (VTE) in the UK between January 2010 and December 2021. ; Inclusion criteria:; • Neonates aged ≤ 28 days at the time of dalteparin initiation and born at gestational age ≥35 weeks; • Diagnosis of VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), based on acceptable imaging modalities including compression ultrasound with doppler (CUD), computed tomography with/without venography (CT/CTV), magnetic resonance imaging with/without venography (MRI/MRV), conventional venography (CV), conventional pulmonary angiogram (CPA), ventilation-perfusion (V/Q) scan, spiral CT angiography (SCTA); • Received ≥ 1 dose of dalteparin for the treatment of VTE; ; Exclusion criteria:; • Patients with bleeding disorders, including, but not limited to platelet dysfunction, disseminated intravascular coagulation, hemophilia, idiopathic thrombocytopenic purpura, or von Willebrand disease.
• Age groups:
  Term newborn infants (0 – 27 days)
• Special population of interest:
  Other
• Special population of interest, other:
  Venous thromboembolism patients
• Estimated number of subjects:
  12

Study design details

• Main study objective:
  Among neonates (≤ 28 days old, and ≥ 35 weeks gestation) treated with dalteparin for VTE, characterize the safety, effectiveness and dosing (starting dose and optimal therapeutic dose) and corresponding anti-Xa assay levels.
• Data analysis plan:
  Descriptive analyses (no formal hypothesis-testing) will be conducted to address study objectives. Frequencies and percentages to describe categorical variables and means and SDs (or medians with IQRs, where appropriate) for continuous or discrete variables will be calculated.