WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Veno… (NCT03297359) | Clinical Trial Compass
TerminatedPhase 2
WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism
Stopped: Low recruitment
Canada92 participantsStarted 2018-03-21
Plain-language summary
Cancer patients that develop blood clots are treated with low molecular weight heparin injections (LMWH). One kind of these LMWHs, dalteparin, has its dose determined based on a patient's weight using a formula of 200 international units (IU) per kilogram (kg). The current dosing of dalteparin approved by Health Canada has a maximum daily dose of 18 000 IU/day which is weight-adjusted for patients up to 90 kg. Any patient weighing more than 90 kg would take the same dosage regardless of their weight. The aim of this study is to assess the safety of using weight-adjusted dalteparin in cancer-associated venous thromboembolism patients that weigh more than 90 kg.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Known pathologically-confirmed cancer (other than basal-cell or squamous-cell carcinoma of the skin),
✓. Confirmed symptomatic or incidental deep vein thrombosis requiring treatment, or confirmed symptomatic or incidental pulmonary embolism of a segmental or larger pulmonary artery,
✓. Weight \> 90 kg,
✓. Age ≥18 years,
✓. Hemoglobin ≥ 80 g/L,
✓. Able and willing to comply with study procedures and follow-up examinations contained within the written consent form.
Exclusion criteria
✕. Acute VTE managed with thrombectomy, insertion of an inferior vena cava filter or with the use of thrombolytic agents,
✕. More than 72 hours pre-treatment with therapeutic dosage of other LMWH, direct oral anticoagulants or vitamin K antagonists prior to enrolment to manage the current VTE event (unless the participant has been treated with weight-adjusted doses of commercial dalteparin in consistency with the dosing regime outlined in the protocol up to Day 7 visit \[±2 days\]),