WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism (WAVe)
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|ClinicalTrials.gov Identifier: NCT03297359|
Recruitment Status : Not yet recruiting
First Posted : September 29, 2017
Last Update Posted : September 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer Venous Thromboembolism Obesity||Biological: Dalteparin||Phase 2|
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 consent, and confirming eligibility, participants weighing more than 90 kg with acute cancer-associated thrombosis will be treated with therapeutic weight-adjusted dalteparin (subcutaneous once daily injection, or twice daily, if the conditions of the participant do not allow once daily injection as per clinical judgement) beginning at enrolment (within 12 hours) and continuing until Day 30 visit or 30 days, whichever comes first. Subjects will receive therapeutic doses of dalteparin at a dose of approximately 200 IU/kg SC daily (up to 32,500 IU) for 26-30 days. Although the Day 30 visit can occur up to 34 days from enrolment, treatment will not surpass 30 days. Following this study period of 30 days (± 4 days), patients will be followed for 5 months. During the follow-up period, each patient will pursue his/her treatment as per usual standard treatment protocols provided at each institution. Treatment used and clinical outcomes will be collected at the end of the follow-up period.
The majority of Canadian Thrombosis specialists use weight adjusted dosing of dalteparin in patients weighing more than 90 kg with cancer-associated VTE. No expert recommends capping the dose of dalteparin to 18,000 IU in patients weighing over 90 kg as suggested by the product monograph. However, the risk of major bleeding episodes in patients over 90 kg receiving weight-adjusted LMWH remains unclear. The estimated rate of major bleeding episodes of patients with cancer associated VTE (Mean weight 79.1 kg) managed with therapeutic dose of dalteparin is 3.6% (95% CI: 1.9 to 6.2). We hypothesize that the rate of major bleeding events will be similar in patients (> 90 kg) with cancer-associated VTE treated with dalteparin 200 IU/kg daily (up to 32,500 IU). We plan to recruit 150 patients in this cohort study. We expect 6 major bleeding events. This would provide us with an overall bleeding event of 4% with an upper bound of the confidence interval of 8.5%). An informal survey of Canadian thrombosis expert has demonstrated that clinicians would feel reassured and continue to use weight-adjusted dalteparin in cancer patients weighing more than 90kg if the upper bound of the 95% confidence interval is less than 9% (i.e. < 3% possible absolute rate difference).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Weight adjusted dalteparin
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 total of 30 days (-4 days).
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 (10,000 and 15,000 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: 32,500 IU daily ( or 3 prefilled syringes (10,000 ; 10,000 and 12,500 IU)
daily subcutaneous injection of weight-adjusted dalteparin
- Major bleeding episode [ Time Frame: up to day 30 ]
- Fatal bleeding, and/or,
- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or,
- Bleeding causing a fall in hemoglobin level of ≥20 g/L, or leading to transfusion of ≥2 units of whole blood or red cells.
- Clinically relevant non major bleeding events [ Time Frame: up to day 30 ]
as overt bleeding episodes not meeting the inclusion for major bleeding but associated with one of the following: 9 CONFIDENTIAL and PROPRIETARY OHRI Protocol Version 1 - 30 AUG 2017
- Medical intervention,
- An unscheduled contact with a physician,
- Temporary cessation of anticoagulant treatment.
- Minor bleeding events [ Time Frame: up to day 30 ]overt bleeding not meeting the major bleeding or clinically-relevant non-major bleeding definitions
- Recurrent VTE events [ Time Frame: Up to day 180 ]
- Recurrent deep vein thrombosis
- Recurrent Pulmonary embolism
- Bioaccumulation defined as bioaccumulation defined as trough anti-Xa level measuring > 0.4 IU/mL done at Day 7 follow-up visit.
- Overall mortality [ Time Frame: Up to day 180 ]death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297359
|Contact: Yan He, BSc||(613) 737-8899 ext email@example.com|
|Principal Investigator:||Marc Carrier, MD||Ottawa Hospital Research Institute|