drugset / Trial / NCT03297359
WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism
Phase 2
Terminated
92 enrolled
Ottawa Hospital Research Institute
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-03-21
- Primary completion
- 2023-11-30
- Completion
- 2023-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalteparin sodium | Other / unclassified | 200 iu/kg | Subcutaneous |
| Subject | Dalteparin sodium | Other / unclassified | 18000 iu | Subcutaneous |
| Subject | Dalteparin sodium | Other / unclassified | 20000 iu | Subcutaneous |
| Subject | Dalteparin sodium | Other / unclassified | 22500 iu | Subcutaneous |
| Subject | Dalteparin sodium | Other / unclassified | 25000 iu | Subcutaneous |
| Subject | Dalteparin sodium | Other / unclassified | 27500 iu | Subcutaneous |
| Subject | Dalteparin sodium | Other / unclassified | 30000 iu | Subcutaneous |
| Subject | Dalteparin sodium | Other / unclassified | 33000 iu | Subcutaneous |