Hospice in-patient deep vein thrombosis detection study
| ISRCTN | ISRCTN97567719 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97567719 |
| Protocol serial number | Version 1.0 |
| Sponsor | University of Hull |
| Funder | National Institute for Health Research |
- Submission date
- 01/06/2016
- Registration date
- 15/07/2016
- Last edited
- 06/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Contact information
Public
Hull York Medical School (Wolfson Palliative Care Research Centre)
University of Hull
Hull
HU6 7RX
United Kingdom
 ORCID ID |
0000-0001-6204-9158 |
|---|
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Longitudinal study |
| Participant information sheet | ISRCTN97567719_PIS_07Jul16.docx |
| Scientific title | HIDDen: Hospice In-patient Deep vein thrombosis Detection study |
| Study acronym | HIDDen |
| Study objectives | 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(s) | Health Research Authority, Yorkshire & The Humber - Leeds West Research Ethics Committee, 17/03/2016, ref: 16/YH/0045 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
The prevalence of femoral DVT in cancer patients admitted to specialist palliative care unit (SPCU) measured by Doppler ultrasound |
| Key secondary outcome measure(s) |
1. Incidence of developing a proximal lower limb DVT in patients with and without a diagnosis of cancer during admission to a SPCU |
| Completion date | 28/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 217 |
| Total final enrolment | 343 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 06/06/2016 |
| Date of final enrolment | 10/10/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
- Northern Ireland
- Wales
Study participating centres
Esher
KT10 8NA
United Kingdom
BT37 9RH
United Kingdom
Belfast
BT5 6NF
United Kingdom
BT36 4TS
United Kingdom
Penarth
Cardiff
CF11 9LJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2019 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | exploratory substudy was the prevalence of DVT in patients with non-malignant palliative conditions | 11/02/2022 | 06/09/2024 | Yes | No |
| Participant information sheet | 07/07/2016 | 26/07/2016 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes | |||
| Protocol file | version 4.0 | 22/09/2016 | 23/08/2022 | No | No |
Additional files
- ISRCTN97567719_PIS_07Jul16.docx
- Uploaded 26/07/2016
- ISRCTN97567719_PROTOCOL_V4.0_22Sep16.pdf
- Protocol file
Editorial Notes
06/09/2024: Publication reference added.
23/08/2022: Protocol file and total final enrolment added.
04/05/2020: Cancer Research UK lay results summary link added to Results (plain English).
11/02/2019: Internal review.
04/02/2019: Publication reference added.
16/02/2018: The recruitment end date has been updated from 01/01/2018 to 10/10/2017. The intention to publish date has been updated from 31/07/2018 to 28/02/2019.
10/04/2017: Link to Cancer Help UK lay summary added to plain English Summary field
26/07/2016: Participant information sheet uploaded
