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

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01602432

Collaborator

The Ottawa Hospital Academic Medical Association (Other)

143

Enrollment

Location

Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Venous Thromboembolism Deep-Vein Thrombosis Pulmonary Embolism Cancer

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.

Study Design

Study Type:

Observational

Actual Enrollment :

143 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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: Site of cancer: classified as very high-risk (+2 points) or high-risk (+1 point). Platelet count: (>350 x 109/L) (+1 point) Hemoglobin level (<100 g/L) and/or use of erythropoiesis stimulating agents (+1 point) Leukocyte count (> 11 x 109/L)(+1 point). 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.

Arm

Intervention/Treatment

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: Site of cancer: classified as very high-risk (+2 points) or high-risk (+1 point). Platelet count: (>350 x 109/L) (+1 point) Hemoglobin level (<100 g/L) and/or use of erythropoiesis stimulating agents (+1 point) Leukocyte count (> 11 x 109/L)(+1 point). 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.

Outcome Measures

Primary Outcome Measures

Risk for Venous Thromboembolism [1 year]
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 [1 year]
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 [1 year]
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 [1 year]
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 [1 year]
This outcome will be measured by the physician's satisfaction to the implementation of an automatic risk detection.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)