Remember Me
Or use your Academic/Social account:


Or use your Academic/Social account:


You have just completed your registration at OpenAire.

Before you can login to the site, you will need to activate your account. An e-mail will be sent to you with the proper instructions.


Please note that this site is currently undergoing Beta testing.
Any new content you create is not guaranteed to be present to the final version of the site upon release.

Thank you for your patience,
OpenAire Dev Team.

Close This Message


Verify Password:
Verify E-mail:
*All Fields Are Required.
Please Verify You Are Human:
fbtwitterlinkedinvimeoflicker grey 14rssslideshare1
Noble, Simon I; Nelson, Annmarie; Fitzmaurice, David; Bekkers, Marie-Jet; Baillie, Jessica; Sivell, Stephanie; Canham, Joanna; Smith, Joanna D; Casbard, Angela; Cohen, Ander; Cohen, David; Evans, Jessica; Fletcher, Kate; Johnson, Miriam; Maraveyas, Anthony; Prout, Hayley; Hood, Kerenza (2015)
Publisher: NIHR Journals Library
Languages: English
Types: Article
Subjects: Research Article, R1
Background\ud Venous thromboembolism is common in cancer patients and requires anticoagulation with low-molecular-weight heparin (LMWH). Current data recommend LMWH for anticoagulation as far as 6 months, yet guidelines recommend LMWH beyond 6 months in patients who have ongoing or active cancer. This recommendation, based on expert consensus, has not been evaluated in a clinical study.\ud Objectives\ud (1) To identify the most clinically and cost-effective length of anticoagulation with LMWH in the treatment of cancer-associated thrombosis (CAT); (2) to identify practicalities of conducting a full randomised controlled trial (RCT) with regard to recruitment, retention and outcome measurement; and (3) to explore the barriers for progressing to a full RCT.\ud Design\ud The Anticoagulation with Low-molecular-weight heparin In the treatment of Cancer-Associated Thrombosis (ALICAT) trial is a randomised, multicentre, feasibility mixed-methods study with three components: (1) a RCT comparing ongoing LMWH treatment for CAT with cessation of LMWH at 6 months’ treatment (current licensed practice) in patients with locally advanced or metastatic cancer, consulted in three clinical settings (haematology outpatients, oncology outpatients and primary care); (2) a nested qualitative study, including focus groups with clinicians to investigate attitudes for recruiting to the study and identify the challenges of progressing to a full RCT, and semistructured interviews with patients and relatives to explore their attitudes towards participating in the study, and potential barriers and concerns to participation; and (3) a UK-wide survey exercise to develop a classification and enumeration system for the CAT models and pathways of care.\ud Setting\ud A haematology outpatients department, an oncology outpatients department and primary care.\ud Participants\ud Patients with ongoing active or metastatic cancer who have received 6 months of LMWH for CAT.\ud Interventions\ud Ongoing LMWH treatment for CAT versus cessation of LMWH at 6 months’ treatment in patients with locally advanced or metastatic cancer.\ud Main outcome measures\ud (i) The number of eligible patients over 12 months; (ii) the number of recruited patients over 12 months (target recruitment rate of 30% of eligible patients); and (iii) the proportion of randomised participants with recurrent venous thromboembolisms (VTEs) during follow-up.\ud Results\ud Following several delays in setting up the RCT component of the study, 5 out of 32 eligible patients consented to be randomised to the RCT suggesting progression to a full RCT was not feasible. Reasons for non-consenting were primarily based on a fixed preference for continuing or discontinuing treatment after 6 months of anticoagulation, and a fear of randomisation to their non-preferred option. Views were largely influenced by patients’ initial experience of CAT. Focus groups with clinicians revealed that they would be reticent to recruit to such a study as they had fixed views of best management despite the lack of evidence. Patient pathway modelling suggested that there is a broad heterogeneity of practice with respect to CAT management and co-ordination, with no consensus on which specialty should best manage such cases.\ud Conclusions\ud The results of the RCT reflect recruitment from the oncology site only and provide no recruitment data from haematology centres. However, it is unlikely that these other sites would have access to more eligible patients. The management of cancer-associated thrombosis beyond 6 months will remain a clinical challenge. As it is unlikely that a prospective study will successfully recruit, other strategies to accrue relevant data are necessary. Currently the LONGHEVA (Long-term treatment for cancer patients with deep-venous thrombosis or pulmonary embolism) registry is in development to prospectively evaluate this important and common clinical scenario.\ud Study registration\ud This study is registered as clinical trials.gov number NCT01817257 and International Standard Randomised Controlled Trial Number (ISRCTN) 37913976.\ud Funding details\ud Funding for the ALICAT trial was provided by the Health Technology Assessment programme (10/145/01) in response to a themed funding call. The study was designed in accordance with the initial funding brief and feedback from the review process.
  • The results below are discovered through our pilot algorithms. Let us know how we are doing!

    • 2. Noble S, Pasi J. Epidemiology and pathophysiology of cancer-associated thrombosis. Br J Cancer 2010;102(Suppl. 1):S2-9. http://dx.doi.org/10.1038/sj.bjc.6605599
    • 3. Keeling D, Baglin T, Tait C, Watson H, Perry D, Baglin C, et al. Guidelines on oral anticoagulation with warfarin - fourth edition. Br J Haematol 2011;154:311-24. http://dx.doi.org/10.1111/ j.1365-2141.2011.08753.x
    • 4. Noble SI, Shelley MD, Coles B, Williams SM, Wilcock A, Johnson MJ. Management of venous thromboembolism in patients with advanced cancer: a systematic review and meta-analysis. Lancet Oncol 2008;9:577-84. http://dx.doi.org/10.1016/S1470-2045(08)70149-9
    • 5. Levitan N, Dowlati A, Remick SC, Tahsildar HI, Sivinski LD, Beyth R, et al. Rates of initial and recurrent thromboembolic disease among patients with malignancy versus those without malignancy. Risk analysis using Medicare claims data. Medicine 1999;78:285-91. http://dx.doi.org/ 10.1097/00005792-199909000-00001
    • 6. Sorensen HT, Mellemkjaer L, Olsen JH, Baron JA. Prognosis of cancers associated with venous thromboembolism. N Engl J Med 2000;343:1846-50. http://dx.doi.org/10.1056/ NEJM200012213432504
    • 7. Noble S. The challenges of managing cancer related venous thromboembolism in the palliative care setting. Postgrad Med J 2007;83:671-4. http://dx.doi.org/10.1136/pgmj.2007.061622
    • 8. Noble SI, Finlay IG. Is long-term low-molecular-weight heparin acceptable to palliative care patients in the treatment of cancer related venous thromboembolism? A qualitative study. Palliat Med 2005;19:197-201. http://dx.doi.org/10.1191/0269216305pm1008oa
    • 9. Khorana AA, Streiff MB, Farge D, Mandala M, Debourdeau P, Cajfinger F, et al. Venous thromboembolism prophylaxis and treatment in cancer: a consensus statement of major guidelines panels and call to action. J Clin Oncol 2009;27:4919-26. http://dx.doi.org/10.1200/JCO.2009.22.3214
    • 10. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008;133(Suppl. 6):454S-545S. http://dx.doi.org/10.1378/ chest.08-0658
    • 11. Meyer G, Marjanovic Z, Valcke J, Lorcerie B, Gruel Y, Solal-Celigny P, et al. Comparison of low-molecular-weight heparin and warfarin for the secondary prevention of venous thromboembolism in patients with cancer: a randomized controlled study. Arch Intern Med 2002;162:1729-35. http://dx.doi.org/10.1001/archinte.162.15.1729
    • 12. Lee A, Levine M, Baker R, Bowden C, Kakkar AK, Prins M, et al. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med 2003;349:146-53. http://dx.doi.org/10.1056/NEJMoa025313
    • 13. Hull R, Pineo G, Brant R, Mah AF, Burke N, Dear R, et al. Long-term low-molecular-weight heparin versus usual care in proximal-vein thrombosis patients with cancer. Am J Med 2006;119:1062-72. http://dx.doi.org/10.1016/j.amjmed.2006.02.022
    • 14. Johnson MJ, Sproule MW, Paul J. The prevalence and associated variables of deep venous thrombosis in patients with advanced cancer. Clin Oncol 1999;11:105-10. http://dx.doi.org/ 10.1053/clon.1999.9023
    • 16. Prandoni P, Lensing AW, Piccioli A, Bernardi E, Simioni P, Girolami B, et al. Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood 2002;100:3484-8. http://dx.doi.org/10.1182/ blood-2002-01-0108
    • 17. Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009;361:2342-52. http://dx.doi.org/10.1056/NEJMoa0906598
    • 18. Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499-510. http://dx.doi.org/ 10.1056/NEJMoa1007903
    • 19. Peetz D, Lackner KJ. Dabigatran versus warfarin for venous thromboembolism. N Engl J Med 2010;362:1050. http://dx.doi.org/10.1056/NEJMc1000696
    • 20. Teachey DT. Dabigatran versus warfarin for venous thromboembolism. N Engl J Med 2010;362:1050. http://dx.doi.org/10.1056/NEJMc1000696
    • 21. Romualdi E, Donadini MP, Ageno W. Oral rivaroxaban after symptomatic venous thromboembolism: the continued treatment study (EINSTEIN-Extension study). Expert Rev Cardiovasc Ther 2011;9:841-4. http://dx.doi.org/10.1586/erc.11.62 32. Beanlands H, Horsburgh M, Fox S, Howe A, Locking-Cusolito H, Pare K, et al. Caregiving by family and friends of adults receiving dialysis. Nephrol Nurs J 2005;32:621-31.
  • Discovered through pilot similarity algorithms. Send us your feedback.

Share - Bookmark

Cite this article