Hospice in-patient deep vein thrombosis detection study | Not Recruiting
Hospice in-patient deep vein thromb... | Not Recruiting
Hospice in-patient deep vein thrombosis detection study
HIDDen

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Medical Conditions
  • Femoral deep vein thrombosis (DVT) in cancer patients admitted to specialist palliative care units (SPCUs).
Primary Contact Details
Prof Johnson Miriam
See all trial contact details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN97567719
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-to-see-how-often-people-with-advanced-cancer-have-blood-clots-in-their-legs-hidden
Research Details
  • 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). There are national treatment recommendations to prevent DVT in cancer patients admitted to hospital. However, it is not known 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. It is not known 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 via the use of a ultrasound scanner, at the hospice bedside, This study will determine how many cancer patients admitted to hospice units have DVTs and whether these cause problems and will result in a better understanding of how we should treat people with advanced cancer.
Phase
Sorry, this information is not available
Study Design
Observational cohort study
Study Type
Observational
Intervention

An ultrasound scanner 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. Patients are also asked about their symptoms, their condition and medications.

Weekly assessments will be undertaken until participants are no longer fit for ongoing assessments, have died, or have been discharged, up to a maximum of 3 weeks' inpatient stay.

Intervention Type
Other
Primary Outcome Measures
    The prevalence of femoral DVT in cancer patients admitted to specialist palliative care unit (SPCU) measured by Doppler ultrasound
Secondary Outcome Measures
    1. Incidence of developing a proximal lower limb DVT in patients with and without a diagnosis of cancer during admission to a SPCU
    2. Prevalence of clinical symptoms and signs attributable to VTE (proximal lower limb DVT and PE) on admission to a SPCU
    3. Incidence of clinical symptoms and signs attributable to VTE (proximal lower limb DVT and PE) during admission to a SPCU
    4. Incidence of acute deterioration or sudden death in patients with a known DVT that could be attributed to clinical pulmonary emboli
    5. Clinical characteristics associated with the presence or absence of proximal lower limb DVT
    6. Association between use of anticoagulation and presence or absence of DVT on admission and during admission to a SPCU
    7. Impact of proximal lower limb DVT on length of stay
    8. Survival
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
217 cancer patients
Participant Inclusion Criteria
    1. Admitted to a participating SPCU
    2. 18 years or older
    3. Able to give fully informed written consent or an available nominated consultee
    4. No physical limitations to performing the ultrasound assessment
Participant Exclusion Criteria
    1. Patients on other clinical trials will be considered on a case by case basis
    2. Patients who are considered by the clinical team likely to die within 5 days
    3. Where, in the case of a patient without mental capacity, the nominated consultee is too distressed to be approached regarding the study in the opinion of the clinical team
    4. Patients unable to understand English well enough to provide informed consent or comply with study assessments
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Wales Cancer Trials Unit
Cardiff
Wales
CF11 9LJ
Investigational site
Belfast
BT5 6NF
W End Ln
Esher
KT10 8NA
Newtownabbey
BT37 9RH
Newtownabbey
BT36 4TS
Trial Contact(s)
Primary Trial Contact
Prof Johnson Miriam
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
HIDDen: Hospice In-patient Deep vein thrombosis Detection study
EudraCT Number
Sorry, this information is not available
Funder(s)
  • National Institute for Health Research
Other Study ID Numbers
Version 1.0
Sponsor(s)
University of Hull
Key Dates

Recruitment Start Date

06 Jun 2016

Recruitment End Date

10 Oct 2017

Trial Start Date

01 Jun 2016

Trial End Date

28 Feb 2018

Date added to source

15 Jul 2016

Date updated in source

16 Feb 2018