A feasibility study to inform the design of a randomized controlled trial to identify the most clinically and cost effective Anticoagulation Length with low molecular weight heparin In the treatment of Cancer Associated Thrombosis (ALICAT): study protoco

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• 作者：Joanna D Smith (1)
  Jessica Baillie (2)
  Trevor Baglin (3)
  Gareth O Griffiths (1)
  Angela Casbard (1)
  David Cohen (4)
  David A Fitzmaurice (5)
  Kerenza Hood (6)
  Peter Rose (7)
  Alexander T Cohen (8)
  Miriam Johnson (9)
  Anthony Maraveyas (9)
  John Bell (1)
  Harold Toone (1)
  Annmarie Nelson (2)
  Simon I Noble (2)
  
  1. Wales Cancer Trials Unit ; Cardiff University School of Medicine ; Heath Park ; Cardiff ; Wales ; CF14 4YS ; UK
  2. Marie Curie Palliative Care Research Centre ; Cardiff University School of Medicine ; Heath Park ; Cardiff ; Wales ; CF14 4YS ; UK
  3. Department of Hematology ; Addenbrooke鈥檚 Hospital ; Cambridge University Hospitals NHS ; Foundation Trust ; Hills Road ; Cambridge ; CB2 0QQ ; UK
  4. Faculty of Health ; Sport and Science ; University of South Wales ; Pontypridd ; CF37 1DL ; UK
  5. Primary Care Clinical Sciences ; School of Health and Population Sciences ; College of Medical and Dental Sciences ; University of Birmingham ; Edgbaston ; Birmingham ; B15 2TT ; UK
  6. South East Wales Trials Unit ; Cardiff University School of Medicine ; Heath Park ; Cardiff ; Wales ; CF14 4YS ; UK
  7. Department of Hematology ; Warwick Hospital ; Lakin Road ; Warwick ; CV34 5BW ; UK
  8. Department of Surgery and Vascular Medicine ; King鈥檚 College Hospital ; Denmark Hill ; London ; SE5 9RS ; UK
  9. Hull York Medical School ; The University of Hull ; Castle Road ; Hull ; HU16 5JQ ; UK
  
• 关键词：Venous thromboembolism ; Pulmonary embolus ; Deep vein thrombosis ; Cancer associated thrombosis ; Low molecular weight heparin ; Randomized controlled trial ; Mixed methods ; Palliative care ; Qualitative research ; Framework analysis
• 刊名：Trials
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：15
• 期：1
• 全文大小：613 KB
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• 刊物主题：Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
• 出版者：BioMed Central
• ISSN：1745-6215

文摘

Background Venous thromboembolism is common in patients with cancer and requires anticoagulation with low molecular weight heparin. Current data informs anticoagulation as far as six months, yet guidelines recommend anticoagulation beyond six months in patients who have locally advanced or metastatic cancer. This recommendation, based on expert consensus, has not been evaluated in a clinical study. ALICAT (Anticoagulation Length in Cancer Associated Thrombosis) is a feasibility study to identify the most clinically and cost effective length of anticoagulation with low molecular weight heparin in the treatment of cancer associated thrombosis. Methods/Design ALICAT is a randomized multi-centre phase two mixed-methods study with three components: a randomized controlled trial, embedded qualitative study and a survey investigating pathways of care. The randomized controlled trial will compare ongoing low molecular weight heparin treatment for cancer-associated thrombosis versus cessation of low molecular weight heparin at six months treatment (current licensed practice) in patients with locally advanced or metastatic cancer. The embedded qualitative study will include focus groups with clinicians to investigate attitudes to recruiting to the study, identify the challenges of progressing to a full randomized controlled trial, and also semi-structured interviews with patients and relatives/carers to explore their attitudes towards participating in the study and potential barriers and concerns to participation. Finally, a UK wide survey exercise will be undertaken to develop a classification and enumeration system for the cancer associated thrombosis models and pathways of care. Discussion There is a lack of evidence determining the length of anticoagulation for patients with cancer associated thrombosis and subsequently treatment length varies. The ALICAT study will consider the feasibility of recruiting patients to a phase three trial. Trial registration Current Controlled Trials ISRCTN37913976.