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

NCT03297359 | Terminated Phase 2 DMC

• 1 other identifier: WAVe-001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Cancer; Venous Thromboembolism; Obesity

Keywords

Dalteparin; Fragmin

Outcome Measures

Primary Outcomes (1)

• Major bleeding episode

  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.

  up to day 30

Secondary Outcomes (5)

• Clinically relevant non major bleeding events

  up to day 30

• Minor bleeding events

  up to day 30

• Recurrent VTE events

  Up to day 180

• Overall mortality

  Up to day 180

• Bioaccumulation of study drug

  Up to day 30

Study Arms (1)

Weight adjusted dalteparin

EXPERIMENTAL

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))

Biological: Dalteparin

Interventions

Dalteparin BIOLOGICAL

daily subcutaneous injection of weight-adjusted dalteparin

Weight adjusted dalteparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network: collaborator

Study Sites (5)

Alberta Health Services

Edmonton, Alberta, T6G 2V2, Canada

Location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Hospital

Hamilton, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto General Hopsital

Toronto, Ontario, M5G 1J6, Canada

Location

Related Publications (1)

• Wang 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 DERIVED

MeSH Terms

Conditions

Neoplasms; Venous Thromboembolism; Obesity

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Marc Carrier, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: September 29, 2017
• Study Start: March 21, 2018
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

CA (5)