WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism (WAVe)
Cancer, Venous Thromboembolism, Obesity
About this trial
This is an interventional treatment trial for Cancer focused on measuring Dalteparin, Fragmin
Eligibility Criteria
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]),
Contraindication to heparin therapy:
- history of heparin induced thrombocytopenia (HIT) as reported by patient,
- platelet count of less than 50 x 109/L,
- actively bleeding,
- reported history of severe uncontrolled hypertension,
- documented peptic ulcer within 6 weeks,
- reported history of severe hepatic failure,
- creatinine clearance of < 30 ml/min as calculated by the Cockcroft-Gault formula,
- heparin allergy,
- Other contraindication to anticoagulation.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status of 3 or 4 at the time of study enrolment,
- Life expectancy < 1 month,
- Women of childbearing age without proper contraceptive measures and women who are pregnant or breast feeding,
- Participating in another interventional trial that may result in co-intervention or contamination (to be determined by sponsor),
- Unable/unwilling to provide informed consent.
Sites / Locations
- Alberta Health ServicesRecruiting
- Nova Scotia Health AuthorityRecruiting
- Juravinski HospitalRecruiting
- The Ottawa HospitalRecruiting
- Toronto General HopsitalRecruiting
Arms of the Study
Arm 1
Experimental
Weight adjusted dalteparin
Participants will receive a daily subcutaneous injection of weight-adjusted dalteparin (See Table below) at a dose of approx. 200 IU/kg beginning on the day of enrolment and for a one month. 91 to 95 kg: 18,000 IU daily ( or 1 prefilled syringe of 18,000 IU) 96 to 105 kg: 20,000 IU daily ( or 2 prefilled syringes of 10,000 IU) 106 to 120 kg: 22,500 IU daily ( or 2 pre-filled syringes (10,000 and 12,500 IU)) 121 to 130 kg: 25,000 IU daily ( or 2 prefilled syringes of 12,500 IU) 131 to 145 kg: 27,500 IU daily ( or 2 pre-filled syringes (12,500 and 15,000 IU)) 146 to 150 kg: 30,000 IU daily ( or 2 prefilled syringes of 15,000 IU) ≥ 151 kg: 33,000 IU daily ( or 2 prefilled syringes (15,000 and 18,000 IU))