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

This study has been completed.
Sponsor:
Collaborator:
The Ottawa Hospital Academic Medical Association
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01602432
First received: May 16, 2012
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

Cancer increases the risk of deep vein blood clots and clots traveling to the lungs (emboli) which cause morbidity (leg swelling, pain, and shortness of breath), sudden death, delays cancer treatment, and decreases cancer survival by 66% compared to similar cancer patients without blood clots. Blood thinners may prevent clots but major bleeding is also a problem, so preventive therapies are not used routinely. Identifying patients at highest risk for clots is critical. A tool exists but it has not been used outside of research. We propose to study how to apply this tool in clinical practice and test if it works.


Condition
Venous Thromboembolism
Deep-Vein Thrombosis
Pulmonary Embolism
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implementing a Tool to Identify Risk for Venous Thromboembolism in Cancer Patients

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Risk for Venous Thromboembolism [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Timing to VTE detection [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    This will be measured by the time elapsed between the first signs or symptoms associated with a symptomatic VTE as described by the patient and the time of confirming VTE diagnosis.

  • Study Feasibility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Feasibility will be assessed by: a) achieving an average enrollment rate of at least 39 cancer patients per month; and b) accomplishing a rate of withdrawals or loss to follow-ups equal or less than 10%

  • Physicians acceptance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    This will be assessed by measurements of physician's satisfaction to the implementation of the Risk stratification tool at the end of the study period.

  • Success of an IS/IT solution [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    This outcome will be measured by the physician's satisfaction to the implementation of an automatic risk detection.


Enrollment: 143
Study Start Date: November 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
High Risk Group

Defined as patients whose primary malignancy is located in the brain, bladder, lung, testicle, stomach, pancreas and lymphatic system and whose risk score before the beginning of anticancer treatment is ≥ 2 according to the Risk Stratification Method proposed by Khorana et al. (2008).

Based on this method, the model includes 5 predictive variables as follows:

  1. Site of cancer: classified as very high-risk (+2 points) or high-risk (+1 point).
  2. Platelet count: (>350 x 109/L) (+1 point)
  3. Hemoglobin level (<100 g/L) and/or use of erythropoiesis stimulating agents (+1 point)
  4. Leukocyte count (> 11 x 109/L)(+1 point).
  5. body mass index (≥ 35 Kg/m2) (+1 point).
Low high Risk Group

Defined as patients whose primary malignancy is located in the brain, bladder, lung, testicle, stomach, pancreas and lymphatic system and whose risk score before the beginning of anticancer treatment is < 2 according to the Risk Stratification Method proposed by Khorana et al. (2008).

In order to confirm the patient low risk status, we will draw a blood sample to determine serum levels of D- dimer and soluble P selectin in patients of this low risk group according to Ay et al. (2010). If levels of D-dimer are ≥ 1.44 µg/mL and/or soluble P selectin ≥ 53.1 ng/mL, we will add one point for each one of the increased biochemical marker and the total score recalculated.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Because of their higher thrombogenic potential, we will aim to identify high-risk cases for VTE within the group of cancer patients whose primary malignancy is located in the brain, bladder, lung, testicle, pancreas, stomach and lymphomas.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602432

Locations
Canada, Ontario
Ottawa Hospital Cancer Center
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
The Ottawa Hospital Academic Medical Association
Investigators
Principal Investigator: Philip S Wells, MD Ottawa Hospital Research Institute
  More Information

Publications:

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01602432     History of Changes
Other Study ID Numbers: 20120209-01H
Study First Received: May 16, 2012
Last Updated: January 10, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Venous Thrombosis
Cancer
Coagulation factors
Blood

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014