Title: A feasibility study to inform the design of a randomised controlled trial to identify the most clinically and cost effective length of Anticoagulation with Low molecular weight heparin In the treatment of Cancer Associated Thrombosis (ALICAT)
Funder: Division for Social Care and Health Research (Wales)

Abstract: Design: Mixed methods feasibility RCT of continuation of LMWH (as per local practice) vs. cessation of LMWH at six months in patients with ongoing cancer and VTE. A nested qualitative study will explore views of clinicians and patients to participation in a phase 3 RCT with particular focus on equipoise and their experiences of long-term LMWH treatment for CAT (where relevant). A scoping exercise will map patient pathways at centres across the UK. Setting: Two NHS hospital outpatient settings: i) oncology (Velindre Cancer Centre; catchment population 1.5 million); ii) haematology (University Hospitals Coventry and Warwickshire NHS Trust; catchment population 800000). Primary Care: recruitment via longstanding primary care research networks (PCRN-CE and MidReC) using 5 practices each in South Birmingham PCT (catchment population 383000) Warwickshire PCT (catchment population 850000) and Oxfordshire PCT (catchment population 672700).Target Population: Patients with ongoing cancer who have received five months LMWH for treatment of CAT. Main Inclusion Criteria: i) receiving LMWH for treatment of CAT for five months; ii) able to self-administer LMWH or have LMWH administered by a carer; iii)able to give informed consent.Health Technologies Assessed: LMWH is an anticoagulant (given daily as a subcutaneous injection) used in the prevention and treatment of VTE. It has a documented safety profile and no significant drug-drug interactions. Dalteparin (Fragmin®) is the only LMWH licensed specifically for the long-term treatment of CAT. Enoxaparin (Clexane®) and tinzaparin (Innohep®) are still used in some practices for the treatment of CAT. As this is a pragmatic feasibility study participating clinicians’ treatment practices will not alter but type of LMWH used will be recorded.Measurement of Costs and OutcomesClinical Study: Eligible patients will be identified through clinical databases (primary and secondary care) and patient records and approached by their usual clinician. Patients will be asked if they would be prepared to continue with LMWH for a further six months; those who agree will be invited to participate in the study. Consenting patients will be randomized to either continue LMWH for a six months (intervention) or to receive current standard care with cessation of LMWH (control). Patients will be followed up every three months for six months from recruitment completing questionnaires on symptoms quality of life and long-term complications of thrombosis and coagulation. Symptoms of recurrent VTE will be investigated and managed on a case by case basis.Primary Outcome Measures: i) number of eligible patients over 12 months; ii) number of recruited patients over 12 months (target recruitment rate of 30%); iii) proportion of participants with recurrent VTEs during follow-up.


Research activity codes: 8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES);6.1 PHARMACEUTICALS
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR