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Implementing a Tool to Identify Risk for Venous Thromboembolism in Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Venous Thromboembolism, Deep-Vein Thrombosis, Pulmonary Embolism, Cancer

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Trial Information

Implementing a Tool to Identify Risk for Venous Thromboembolism in Cancer Patients


Patients with Cancer have a risk for venous thromboembolism (VTE) including deep-vein
thrombosis (DVT) and/or pulmonary embolism (PE) that is markedly higher than non-Cancer
patients. An acute episode of VTE has deleterious effects on the quality of life and
long-term survival of cancer patients. Cancer patients with VTE have survival rates that are
only one third of otherwise identical patients without VTE. Once VTE is diagnosed over 10%
of cancer patients suffer a further event while on standard therapy and over 5% suffer a
major hemorrhagic event.

The best way to treat VTE is its prevention (thromboprophylaxis). Studies suggest that among
ambulatory cancer patients, risk for VTE varies markedly between patients and that the lack
of knowledge of this risk, delays diagnosis and hampers efforts to effectively prevent VTE.
Therefore, the identification of patients at high-risk for VTE may enable faster diagnosis
of VTE and better use of thromboprophylaxis.

Recent studies have developed a novel tool to stratify VTE risk in cancer patients before
they initiate anti-cancer treatment. We hypothesized that this risk tool will accurately
identify cancer patients at high-risk and that its implementation in our clinical practice
will result in a faster clinical diagnosis of VTE.

Our objective is: a) to evaluate the ideal strategy to incorporate the tool in our clinical
setting as seamlessly as possible, and b) to determine whether the tool accurately predicts
risk and results in a faster investigation for VTE.

Patient eligibility will be determined during the patient's initial consult to the Ottawa
Cancer Center after cancer diagnosis has been confirmed by the medical Oncologist and before
initiation of anticancer treatment. Follow-up for this study will be for 12 months and
patients will be seen at the time of scheduled appointments for cancer treatment.


Inclusion Criteria:



- 18 years old or older

- with a newly diagnosed cancer site (brain, bladder, lung, testicle, pancreas, stomach
and lymphomas)

- or progression of the malignant disease after complete or partial remission who have
not recently received chemotherapy (≤ 3 months), radiotherapy and surgery (≤ 2 weeks)

Exclusion Criteria:

- Cancer patients with confirmed VTE or arterial embolism within the last 3 months

- Cancer patients who are receiving continuous anticoagulation

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Risk for Venous Thromboembolism

Outcome Description:

This outcome will be measured by the cummulative rates of VTE stratified by the different categories of risk as determined by the prediction tool during the time-frame of the study

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Philip S Wells, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ottawa Hospital Research Institute

Authority:

Canada: Ethics Review Committee

Study ID:

20120209-01H

NCT ID:

NCT01602432

Start Date:

November 2012

Completion Date:

September 2013

Related Keywords:

  • Venous Thromboembolism
  • Deep-Vein Thrombosis
  • Pulmonary Embolism
  • Cancer
  • Venous Thrombosis
  • Cancer
  • Coagulation factors
  • Blood
  • Embolism
  • Pulmonary Embolism
  • Thromboembolism
  • Thrombosis
  • Venous Thrombosis
  • Venous Thromboembolism

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