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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01602432
• Other study ID #: 20120209-01H
• Status: Withdrawn
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: September 2014
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Deep-Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Locations

Country	Name	City	State
Canada	Ottawa Hospital Cancer Center	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	The Ottawa Hospital Academic Medical Association

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Timing to VTE detection	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.	1 year
Secondary	Study Feasibility	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%	1 year
Secondary	Physicians acceptance	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.	1 year
Secondary	Success of an IS/IT solution	This outcome will be measured by the physician's satisfaction to the implementation of an automatic risk detection.	1 year