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Open Access Study protocol

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 protocol for a mixed-methods study

Joanna D Smith1, Jessica Baillie2*, Trevor Baglin3, Gareth O Griffiths1, Angela Casbard1, David Cohen4, David A Fitzmaurice5, Kerenza Hood6, Peter Rose7, Alexander T Cohen8, Miriam Johnson9, Anthony Maraveyas9, John Bell1, Harold Toone1, Annmarie Nelson2 and Simon I Noble2

Author Affiliations

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's 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’s College Hospital, Denmark Hill, London SE5 9RS, UK

9 Hull York Medical School, The University of Hull, Castle Road, Hull HU16 5JQ, UK

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Trials 2014, 15:122  doi:10.1186/1745-6215-15-122

Published: 12 April 2014

Abstract

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.

Keywords:
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