HIDDen study

• Research type

  Research Study

• Full title

  Hidden: Hospice In-patient Deep vein thrombosis Detection study

• IRAS ID

  180455

• Contact name

  Miriam Johnson

• Contact email

  miriam.johnson@hyms.ac.uk

• Sponsor organisation

  University of Hull

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Up to one in five cancer patients will develop blood clots in their veins known as deep vein thrombosis (DVT). A clot may break off from the DVT and travel to the lungs; known as a pulmonary embolism (PE). We do not know the true number of DVTS and PE as they may not cause symptoms. Neither do we know whether apparently “silent” DVTs, if untreated, go away by themselves, or go on to cause serious problems like swollen, painful legs (DVT), or chest pain, breathlessness, collapse or death (PE). There are national treatment recommendations to prevent DVT in cancer patients admitted to hospital. However, we do not know whether these should apply to patients with advanced cancer admitted to specialist palliative care units (SPCU) such as hospices, as treatment may not alter how long patients have to live or improve symptoms and quality of life. We do not know if good effects outweigh side-effects of treatment (e.g. bleeding) in these patients.
  The aim of the HIDDen study is to find out how many cancer patients admitted to hospice units have a DVT. An ultrasound scanner (a safe simple scan which uses sound waves like the scans used in pregnant women to see the baby in the womb), at the hospice bedside, will be used to scan patients’ legs to test whether they have a DVT. Symptoms will be noted, and patients re-scanned a week later. Consecutive admissions to hospices in England (one site), Northern Ireland (three sites) and Wales (one site) will be recruited until at least 217 cancer patients not on treatment to prevent a blood clot have been scanned. This study will tell us how many cancer patients admitted to hospice units have DVTs and whether these cause problems. We will then understand better how we should treat people with advanced cancer.

  Lay Summary of Results:

  BACKGROUND: It is thought that up to one in five people with cancer will develop venous thromboembolism (VTE; blood clots in their veins or lungs) during their illness. The true number is unknown as people may have no symptoms, or the symptoms thought to be due to the cancer. We do not know if untreated “silent” deep vein thromboses (DVTs) settle by themselves, or go on to cause swollen, painful legs, or send a clot to the lung to cause chest pain, breathlessness, collapse or death. There are UK treatment guidelines to prevent VTE in cancer patients admitted to hospital but we do not know whether these apply to people with advanced cancer admitted to specialist palliative care units (SPCUs) such as hospices. We do not know if treatment to prevent VTE improves symptom control and quality of life, or outweighs the risk of treatment (e.g. bleeding).
  WHAT WE DID: We aimed to find out how many cancer patients admitted to SPCUs have a DVT. Patients with cancer admitted to five SPCUs in England, Wales and Northern Ireland had an ultrasound scan of both thigh and groin veins to look for DVT and were asked about symptoms. They were re-scanned weekly and reviewed for symptoms till discharge (to a maximum of 3 weeks) or death.
  FINDINGS: Of the 232 patients with the most accurate scans, 64 (28%) – just under a third – had a DVT. On average, patients needed considerable assistance and frequent medical care. Patients with previously known VTE, who had been bedbound in the last 12 weeks and with leg swelling were more likely to have a DVT. Patients with DVT did not die sooner than those without, and patients on treatment to prevent DVT were as likely to have DVT as not. Very few patients developed a new DVT or had bleeding during their hospice stay.
  CONCLUSION: DVT in SPCU in-patients is common on admission and more likely in people who have been bedbound recently. DVT prevention treatment on admission did not seem to prevent DVT, survival was not affected and very few developed a new DVT during their stay. This may mean that DVT prevention measures on admission to a SPCU has little benefit, and treatment of a DVT may not be helpful for such patients with few or no symptoms and advanced cancer.

  Has the registry been updated to include summary results?: Yes
  If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.isrctn.com%252FISRCTN97567719%253Fq%253DISRCTN97567719%2526filters%253D%2526sort%253D%2526offset%253D1%2526totalResults%253D1%2526page%253D1%2526pageSize%253D10%2FNBTI%2Fo_XFAQ%2FAQ%2Fd89398ee-5254-48e4-a439-90a3f6bb9988%2F1%2FY7yEZB7m8a&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7Cd24043a532f0492cbc8108dec538b807%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639165044564621695%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=UloqAvGEiI65k7B8i8NN2V2la89mVWtQ4xFXpr9Fs%2F4%3D&reserved=0
  If no – why not?:
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.isrctn.com%252FISRCTN97567719%253Fq%253DISRCTN97567719%2526filters%253D%2526sort%253D%2526offset%253D1%2526totalResults%253D1%2526page%253D1%2526pageSize%253D10%2FNBTI%2Fo_XFAQ%2FAQ%2Fd89398ee-5254-48e4-a439-90a3f6bb9988%2F1%2FY7yEZB7m8a&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7Cd24043a532f0492cbc8108dec538b807%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639165044564659276%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=LcFnoDAlwrz%2BT21YUpnIPae8WbVVNgY%2FHqP1Me9sEnM%3D&reserved=0 for summary

  1. main findings paper - https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F30709436%252F%2FNBTI%2Fo_XFAQ%2FAQ%2Fd89398ee-5254-48e4-a439-90a3f6bb9988%2F2%2FQEHAX0Zruk&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7Cd24043a532f0492cbc8108dec538b807%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639165044564693644%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=QCftRLioW%2Fj1akOsjCXgcoYQal6BNiFoLFDupZvGW0o%3D&reserved=0
  2. Exploratory paper -
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F32046963%252F%2FNBTI%2Fo_XFAQ%2FAQ%2Fd89398ee-5254-48e4-a439-90a3f6bb9988%2F3%2FuNuX371rHX&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7Cd24043a532f0492cbc8108dec538b807%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639165044564730554%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=LbwRbJENwjL2an3ivEpNjO%2BKFftRAovKXZXFBNPblIM%3D&reserved=0
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Yes
  If yes, describe and/or provide URLs to materials shared and how they were shared: Due to the nature of the participants involved (last weeks/days of life) we sent the lay summary to recruiting centres to send to surviving participants. In practice, by the time the project had finished and been reported, there were very few, if any.
  If pending, date when feedback is expected:
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: Yes
  If yes, describe or provide URLs to how it has been shared: The published paper contained a data sharing statement to the effect that data would be shared on reasonable request by contacting the corresponding author
  If no, explain why sharing hasn't been enabled:
  Have you enabled sharing of tissue samples and associated data with others?: Yes
  If yes, describe or provide a URL: Data were shared with a statistician from the lead university to explore survival models. No publication resulted from this.
  If no, explain why:
  Captcha: 0cAFcWeA5UAk3whOICn3oTc2yRimhWo8sQZKKDxwp3gBUXOIRM3ca3PJ8mw6_KhYdnNUDjXOjaA7LQ0PmMGbEexNKDunXSUBJZco_hHgEhk7LX25QpGn30zTFe5FuZHokIVaBoDN3DZZMrzMQI_PBoxj4ekKXrKolN0RQ9qpqpsAQbIin3WYtwO_QYjFqj6WLlz3KHk72yyMF3O3_XJaANVLqkjQ7tFnPez5OgX_6gOy6O4by-8J-iJvZBpQaic1F1IdihULTrN6qHygQLb9vGRbcXXI41l_wqnppwMqvAuRbPTZYJWR8qKBMsgwHCx3gKtR9toEJcwC0vX1F-wH0h2s2srjAOBfMIlObyJDwlJ8z3dXjnDC6wq4ySztXx-DFNlcbyyIQoP3oLifXcFm5tu4xqGwpLTvCkDPRM8AE6-cU-tjRVp0SoPshA4FKzfL2CTImsLJ1bZPTOvHXI17mXVsUAvNMnA7zsWP7qEWx7QVavTqnPn3v6LCvRcP2nckf7HXO33D_7ytCTvwc1LAsbHZSRoOlfMQMXapOYN3k24TePBjC4cOIUAEAMEKLcwypHklhzpbJH0GtdUz3fOlEhLLIZmC6zM0QsSGmbD_lhRLMGEiVIehSG9aFNuQF7N03te6oPTjw60qQoaNnL-CSkp3dX5KnVVHxwzdwoNPVac0YKzWI3kKp3uN28NBi10AudQSY-GTdrrYKbZJAiS193PK0QeeugbzSQ-wjmzsv1MgOR3ImC1LsC1J8SqzGrg2UyAVra8A0UJR3Zd6Co7XJSAjbWm1eys-3IpExQfM9dxbI-DMv_nzETantwb5KV3O69llYlBs3B1KmMji5xCMeoF35-jlY-LzhVxt3e_YEcw6tmLFMcluc_WiT7LyAv8NqiXCDA8ps1dOE6cC3fRH384cOhbKhasFtbAAzEmZnoDNgsVeLlRnwW8aw_xvmYRI3qJbErdLIX3iIrmUk8ptGL5m4lb0bXL3--PbiSoa5cfT2W6ymLN_FTcr5ueKsGtz2z7z56rDEw0cVKgznOrD5gz2D-5XbBy9vK1ypMUY-9bL-1bWoCc6FnFzFCwmAL9D1CH3JUlyfZp3Bo
  

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  16/YH/0045

• Date of REC Opinion

  11 Mar 2016

• REC opinion

  Further Information Favourable Opinion