WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism

Trial details

Who runs it

Ottawa Hospital Research Institute

Trial code

NCT03297359

Record updated

2024. január 23.

Original description

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.Read full original descriptionShow less

A Multicentre Prospective Cohort Study Assessing the Use of Weight-Adjusted Low-Molecular-Weight-Heparin in Patients Over 90 kg With Acute Cancer-Associated Venous Thromboembolism

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.

Inclusion: 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: 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; Women of childbearing age without proper contraceptive measures and women who are pregnant or breast feeding,; Acute VTE managed with thrombectomy, insertion of an inferior vena cava filter or with the use of thrombolytic agents,; An Eastern Cooperative Oncology Group (ECOG) Performance Status of 3 or 4 at the time of study enrolment,; Life expectancy < 1 month,; Participating in another interventional trial that may result in co-intervention or contamination (to be determined by sponsor),; Unable/unwilling to provide informed consent.

ClinicalTrials.gov NCT03297359