Clinical trial · Interventional
WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Obesity | — | UNRESOLVED | — |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dalteparin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Weight adjusted dalteparin
- description
- 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))
- interventionNames
- Biological: Dalteparin
Primary outcomes (1)
- measure
- Major bleeding episode
- timeFrame
- up to day 30
- description
- 1. Fatal bleeding, and/or, 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or, 3. Bleeding causing a fall in hemoglobin level of ≥20 g/L, or leading to transfusion of ≥2 units of whole blood or red cells.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Known pathologically-confirmed cancer (other than basal-cell or squamous-cell carcinoma of the skin), 2. Confirmed symptomatic or incidental deep vein thrombosis requiring treatment, or confirmed symptomatic or incidental pulmonary embolism of a segmental or larger pulmonary artery, 3. Weight \> 90 kg, 4. Age ≥18 years, 5. Hemoglobin ≥ 80 g/L, 6. Able and willing to comply with study procedures and follow-up examinations contained within the written consent form. Exclusion Criteria: 1. Acute VTE managed with thrombectomy, insertion of an inferior vena cava filter or with the use of thrombolytic agents, 2. 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 \[±2 days\]), 3. Contraindication to heparin therapy: 1. history of heparin induced thrombocytopenia (HIT) as reported by patient, 2. platelet count of less than 50 x 109/L, 3. actively bleeding, 4. reported history of severe uncontrolled hypertension, 5. documented peptic ulcer within 6 weeks, 6. reported history of severe hepatic failure, 7. creatinine clearance of \< 30 ml/min as calculated by the Cockcroft-Gault formula, 8. heparin allergy, 9. Other contraindication to anticoagulation. 4. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 3 or 4 at the time of study enrolment, 5. Life expectancy \< 1 month, 6. Women of childbearing age without proper contraceptive measures and women who are pregnant or breast feeding, 7. Participating in another interventional trial that may result in co-intervention or contamination (to be determined by sponsor), 8. Unable/unwilling to provide informed consent.
References
Publications (1)
- DERIVEDWang TF, Yeo E, Gross PL, Seguin C, Wu C, Shivakumar S, Mallick R, Delluc A, D'Astous J, Kimpton M, Roberge G, Siegal DM, Tritschler T, Le Gal G, Carrier M. A Multicenter Prospective Cohort Study on the Use of Weight-Adjusted Dalteparin in Patients Over 90 kg With Acute Cancer-Associated Venous Thromboembolism-The WAVe Study. Am J Hematol. 2026 Jan;101(1):79-88. doi: 10.1002/ajh.70127. Epub 2025 Nov 10. PMID 41211763