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CancerPhase 2WAVeNCT03297359

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

A Phase 2 study testing Dalteparin in people with Cancer and Venous Thromboembolism, run by Ottawa Hospital Research Institute at 5 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Venous Thromboembolism, Obesity
What is being tested?
Dalteparin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
5 sitesCanada
Study dates
21 Mar 2018to 30 Nov 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Alberta Health Services

    Edmonton, Alberta, T6G 2V2

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Hospital

    Hamilton, Ontario

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Toronto General Hopsital

    Toronto, Ontario, M5G 1J6

Other trials in Canada

About this study

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

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.

Read the 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 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. Subjects will receive therapeutic doses of dalteparin at a dose of approximately 200 IU/kg SC daily (up to 33,000 IU) for one month. 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 33,000 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).

Being tested
Dalteparin
Keywords
Dalteparin, Fragmin
Medical subject headings
Neoplasms, Venous Thromboembolism, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DalteparinBiological

    daily subcutaneous injection of weight-adjusted dalteparin

Study groups in NCT03297359
Study groupRoleWhat they receive
Weight adjusted dalteparinExperimentalParticipants 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))
Receives: Biological: Dalteparin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to day 30

Secondary outcomes (5)

  1. Clinically relevant non major bleeding events

    As overt bleeding episodes not meeting the inclusion for major bleeding but associated with one of the following:

    1. Medical intervention,
    2. An unscheduled contact with a physician,
    3. Temporary cessation of anticoagulant treatment.

    Measured: up to day 30

  2. Minor bleeding events

    Overt bleeding not meeting the major bleeding or clinically-relevant non-major bleeding definitions

    Measured: up to day 30

  3. Recurrent VTE events

    1. Recurrent deep vein thrombosis
    2. Recurrent Pulmonary embolism

    Measured: Up to day 180

  4. Overall mortality

    Death

    Measured: Up to day 180

  5. Bioaccumulation of study drug

    Trough anti-Xa levels measured at Day 7 and Day 30 follow-up visits will be generated for the once and twice-daily dosing regimen

    Measured: Up to day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2017
  2. Study start21 Mar 2018
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2023

Why it stopped: Low recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03297359
Sponsor's protocol ID
WAVe-001
Acronym
WAVe
Status last verified
Jan 2024
First submitted
26 Sep 2017
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41211763

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dalteparin in people with Cancer and Venous Thromboembolism, run by Ottawa Hospital Research Institute at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major bleeding episode (time frame: up to day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03297359, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.

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WAVe Clinical Trial NCT03297359 | AzTrials