Contact information
Type
Public
Primary contact
Prof Johnson Miriam
ORCID ID
http://orcid.org/0000-0001-6204-9158
Contact details
Hull York Medical School (Wolfson Palliative Care Research Centre)
University of Hull
Hull
HU6 7RX
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1.0
Study information
Scientific title
HIDDen: Hospice In-patient Deep vein thrombosis Detection study
Acronym
HIDDen
Study hypothesis
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.
Ethics approval
Health Research Authority, Yorkshire & The Humber - Leeds West Research Ethics Committee, 17/03/2016, ref: 16/YH/0045
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Other
Trial type
Other
Patient information sheet
See additional files
Condition
Femoral deep vein thrombosis (DVT) in cancer patients admitted to specialist palliative care units (SPCUs).
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
Phase
Drug names
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
Overall trial start date
01/06/2016
Overall trial end date
28/02/2018
Reason abandoned
Eligibility
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 type
Patient
Age group
Adult
Gender
Both
Target number of participants
217 cancer patients
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
Recruitment start date
06/06/2016
Recruitment end date
01/01/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Princess Alice Hospice
W End Ln
Esher
KT10 8NA
United Kingdom
Trial participating centre
Northern Ireland Hospice
Newtownabbey
BT37 9RH
United Kingdom
Trial participating centre
Marie Curie Hospice
1A Kensington Rd
Belfast
BT5 6NF
United Kingdom
Trial participating centre
Macmillan Unit
Antrim
BT36 4TS
United Kingdom
Trial participating centre
Marie Curie Hospice
Bridgeman Rd
Penarth
Cardiff
CF11 9LJ
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Peer reviewed journals and presentations at national and international conferences.
Intention to publish date
31/07/2018
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Publication citations
Additional files
- ISRCTN97567719_PIS_07Jul16.docx Uploaded 26/07/2016