NCT01602432|Withdrawn
Study Stopped
Project did not meet criteria of a research study and was confirmed as a Quality Initiative Project
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Project did not meet criteria of a research study and was confirmed as a Quality Initiative Project
Sponsor study identifier
observational
0
1 country
1
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 16, 2012
Actual (reported)May 21, 2012
Actual (reported)November 2012
Date type not reportedThis date has not been verified as actual or estimated.
August 2013
Actual (reported)August 2013
Actual (reported)Risk for Venous Thromboembolism
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
1 year
Timing to VTE detection
1 year
Study Feasibility
1 year
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).
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.
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.
Ottawa Hospital Cancer Center
Ottawa, Ontario, K1H 8L6, Canada
Noble S, Pasi J. Epidemiology and pathophysiology of cancer-associated thrombosis. Br J Cancer. 2010 Apr 13;102 Suppl 1(Suppl 1):S2-9. doi: 10.1038/sj.bjc.6605599.
Louzada ML, Majeed H, Dao V, Wells PS. Risk of recurrent venous thromboembolism according to malignancy characteristics in patients with cancer-associated thrombosis: a systematic review of observational and intervention studies. Blood Coagul Fibrinolysis. 2011 Mar;22(2):86-91. doi: 10.1097/MBC.0b013e328341f030.
Philip S Wells, MD
Ottawa Hospital Research Institute
0 participants (actual enrollment reported by the registry).
First Submitted
May 16, 2012
First Posted
May 21, 2012
Study Start
November 2012
Date type not reportedThis date has not been verified as actual or estimated.
Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE)
Physicians acceptance
1 year
Success of an IS/IT solution
1 year
Contact the study team to confirm eligibility.
Lee AY, Levine MN, Baker RI, Bowden C, Kakkar AK, Prins M, Rickles FR, Julian JA, Haley S, Kovacs MJ, Gent M; Randomized Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer (CLOT) Investigators. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med. 2003 Jul 10;349(2):146-53. doi: 10.1056/NEJMoa025313.
Khorana AA, Francis CW, Culakova E, Fisher RI, Kuderer NM, Lyman GH. Thromboembolism in hospitalized neutropenic cancer patients. J Clin Oncol. 2006 Jan 20;24(3):484-90. doi: 10.1200/JCO.2005.03.8877.
Khorana AA, Connolly GC. Assessing risk of venous thromboembolism in the patient with cancer. J Clin Oncol. 2009 Oct 10;27(29):4839-47. doi: 10.1200/JCO.2009.22.3271. Epub 2009 Aug 31.
Khorana AA, Kuderer NM, Culakova E, Lyman GH, Francis CW. Development and validation of a predictive model for chemotherapy-associated thrombosis. Blood. 2008 May 15;111(10):4902-7. doi: 10.1182/blood-2007-10-116327. Epub 2008 Jan 23.
Ay C, Dunkler D, Marosi C, Chiriac AL, Vormittag R, Simanek R, Quehenberger P, Zielinski C, Pabinger I. Prediction of venous thromboembolism in cancer patients. Blood. 2010 Dec 9;116(24):5377-82. doi: 10.1182/blood-2010-02-270116. Epub 2010 Sep 9.
Carrier M, Tay J, Fergusson D, Wells PS. Thromboprophylaxis for catheter-related thrombosis in patients with cancer: a systematic review of the randomized, controlled trials. J Thromb Haemost. 2007 Dec;5(12):2552-4. doi: 10.1111/j.1538-7836.2007.02751.x. No abstract available.
Stanley A, Young A. Primary prevention of venous thromboembolism in medical and surgical oncology patients. Br J Cancer. 2010 Apr 13;102 Suppl 1(Suppl 1):S10-6. doi: 10.1038/sj.bjc.6605600.
Primary Completion
August 2013
Actual (reported)Study Completion
August 2013
Actual (reported)Last Updated
February 27, 2023
Record last verified: 2014-09
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