- Open label, multi-center, randomized control trial
- Inclusion criteria: children ≥ 60 days and ≤ 18 years old with DVR confirmed by either venography or Doppler US or PE confirmed by VQ scan or pulmonary angiogram.
- Exclusion criteria: DVT in CNS, expected lack of compliance, treatment with high dose UFH, LMWH, or OA for more than 48hr at the time of randomization, a documented history of HIT, marked thrombocytopenia (plts <20K), active bleeding or high risk of bleeding with use of anticoagulation therapy, known contraindication to anticoagulation, severe untreated HTN (2x upper limit for normal for age sustained over 24hrs), severe renal dysfunction, severe hepatic disease, bacterial endocarditis, pregnancy, currently lactating, failure to provide informed consent.
- Data collected at 3 months and 6 months
- Primary efficacy outcome: Recurrent VTE at 3 months or 6 months
- Primary safety outcome: Major (clinically significant overt bleeding that required immediate transfusion or any retroperitoneal, intracranial or intra-articular bleeding) or minor (bruising, oozing) bleeding.
- Results: No statistically significant difference in efficacy or safety outcomes between OA and LMWH.
- Power of study was poor as sample size was small and study terminated early.