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 ThrombosisReportar como inadecuado




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 - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 15:122

First Online: 12 April 2014Received: 10 January 2014Accepted: 20 March 2014DOI: 10.1186-1745-6215-15-122

Cite this article as: Smith, J.D., Baillie, J., Baglin, T. et al. Trials 2014 15: 122. doi:10.1186-1745-6215-15-122

Abstract

BackgroundVenous 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-DesignALICAT 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.

DiscussionThere 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 registrationCurrent Controlled Trials ISRCTN37913976.

KeywordsVenous thromboembolism Pulmonary embolus Deep vein thrombosis Cancer associated thrombosis Low molecular weight heparin Randomized controlled trial Mixed methods Palliative care Qualitative research Framework analysis AbbreviationsALICATAnticoagulation Length in Cancer Associated Thrombosis

CATCancer Associated Thrombosis

CRFCase Report Form

DVTDeep vein thrombosis

ESAS-REdmonton Symptom Assessment System Revised

HTAHealth Technology Assessment

IMPInvestigative Medicinal Product

LMWHLow molecular weight heparin

MHRAMedicines and Healthcare products Regulatory Agency

NIHRNational Institute for Health Research

NHSNational Health Service

PEPulmonary embolus

RCTRandomized controlled trial

SPCSummary of Product Characteristics

UKUnited Kingdom

VKAvitamin K antagonist

VTEVenous thromboembolism.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-122 contains supplementary material, which is available to authorized users.

Joanna D Smith, Jessica Baillie contributed equally to this work.

Download fulltext PDF



Autor: Joanna D Smith - Jessica Baillie - Trevor Baglin - Gareth O Griffiths - Angela Casbard - David Cohen - David A Fitzmauri

Fuente: https://link.springer.com/







Documentos relacionados