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临床试验/NCT01817257
NCT01817257终止2 期

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

Cardiff University5 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
2
试验地点
5
主要终点
Number of eligible and recruited patients (target recruitment rate of 30% of eligible patients) over 12 months, and proportion of participants with recurrent VTEs during follow-up.

研究概览

简要总结

This is a two year, multicentre, mixed methods feasibility study including a randomised controlled two-arm interventional trial, a nested qualitative study, focus groups and a United Kingdom (UK) wide survey exercise.

详细描述

Venous thromboembolism (VTE) is a term to describe blood clots in the legs known as a deep vein thrombus (DVT) or lung, known as a pulmonary embolus (PE). It is a common condition, which causes many symptoms including leg pain, swelling, chest pain and breathlessness. At its most serious, VTE may lead to sudden collapse and death.

Treating VTE costs the UK National Health Service (NHS) £640 million every year, including the long-term complications experienced by nearly a third of patients. VTE treatment usually consists of three to six months blood thinning medicine known as an anticoagulant. For most patients, a tablet called warfarin is used, which requires regular blood tests to ensure the blood is adequately and safely thinned.

We also know that VTE is particularly common in cancer. In the UK, over 250,000 people are diagnosed each year with cancer, of which nearly a fifth will develop VTE. Warfarin is a potentially risky treatment in cancer patients because it may increase the risk of bleeding. Also, VTE may come back in a fifth of patients who are treated with warfarin.

Research has shown that a medicine known as low molecular weight heparin (LMWH) is better than warfarin at treating VTE in cancer patients and decreases the chance of VTE coming back by half. LMWH is given as an injection once a day. Studies have shown that giving the drug as an injection is acceptable to patients, as some patients prefer this to the regular blood tests they need to have for warfarin monitoring. LMWH is also simpler to use since it does not cause problems for patients taking other medicines which is a common problem for patients taking warfarin.

Cancer patients get VTE because the cancer can make the blood sticky and this makes it more likely to clot. It is recommended that patients take LMWH for six months only. However, if someone still has a cancer after six months of treatment with LMWH, there is still a strong chance that the VTE could come back because the cancer causing the blood clots has not gone away. This means that these patients might benefit from taking LMWH for longer than six months. We do not know though whether this would improve the patients' quality of life, help prevent death, or be cost-effective to the NHS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Receiving LMWH for treatment of CAT for five months
  • Locally advanced or metastatic cancer
  • Able to self-administer LMWH, or have LMWH administered by a carer
  • Able to give informed consent
  • Age ≥16 years

排除标准

  • Receiving drug other than LMWH for CAT
  • Contraindication to anticoagulation
  • Fitted with a prosthetic heart valve
  • Pregnant and/or lactating females

研究组 & 干预措施

A: Continue treatment

Experimental

Continue low molecular weight heparin (LMWH) at treatment dose according to body weight for further six months.

干预措施: Low Molecular Weight Heparin (LMWH) (Drug)

结局指标

主要结局

Number of eligible and recruited patients (target recruitment rate of 30% of eligible patients) over 12 months, and proportion of participants with recurrent VTEs during follow-up.

时间窗: 24 months

次要结局

  • Completion of trial protocol(24 months)
  • Quality of life(24 months)
  • Symptom assessment during the study(24 months)
  • Attitudes of clinicians and patients to extended treatment with LMWH(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisette Nixon

Senior Trial Manager

Cardiff University

研究点 (5)

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