Status:
TERMINATED
WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Conditions:
Cancer
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
The study is designed as a multicentre prospective cohort study with multiple Canadian sites. It will be initiated at The Ottawa Hospital prior to being offered externally. After obtaining informed co...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
March 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03297359
Start Date
March 21 2018
End Date
November 30 2023
Last Update
January 23 2024
Active Locations (5)
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1
Alberta Health Services
Edmonton, Alberta, Canada, T6G 2V2
2
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
3
Juravinski Hospital
Hamilton, Ontario, Canada
4
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6