Hospice in-patient deep vein thrombosis detection study
| ISRCTN | ISRCTN97567719 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97567719 |
| Secondary identifying numbers | Version 1.0 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Prof Johnson Miriam
Public
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
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Other |
| Study type | Other |
| 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 | 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 study start date | 01/06/2016 |
| Completion date | 28/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 217 cancer patients |
| 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
- England
- Northern Ireland
- United Kingdom
- Wales
Study participating centres
Princess Alice Hospice
W End Ln
Esher
KT10 8NA
United Kingdom
Esher
KT10 8NA
United Kingdom
Northern Ireland Hospice
Newtownabbey
BT37 9RH
United Kingdom
BT37 9RH
United Kingdom
Marie Curie Hospice
1A Kensington Rd
Belfast
BT5 6NF
United Kingdom
Belfast
BT5 6NF
United Kingdom
Macmillan Unit
Antrim
BT36 4TS
United Kingdom
BT36 4TS
United Kingdom
Marie Curie Hospice
Bridgeman Rd
Penarth
Cardiff
CF11 9LJ
United Kingdom
Penarth
Cardiff
CF11 9LJ
United Kingdom
Sponsor information
University of Hull
University/education
University/education
Cottingham Road
Hull
HU6 7RX
England
United Kingdom
"ROR" |
https://ror.org/04nkhwh30 |
|---|
Funders
Funder type
Government
National Institute for Health Research
No information available
Results and Publications
| Intention to publish date | 28/02/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Peer reviewed journals and presentations at national and international conferences. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Participant information sheet | 07/07/2016 | 26/07/2016 | No | Yes | |
| Results article | results | 01/02/2019 | Yes | No | |
| Protocol file | version 4.0 | 22/09/2016 | 23/08/2022 | No | 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 |
Additional files
- ISRCTN97567719_PIS_07Jul16.docx
- Uploaded 26/07/2016
- ISRCTN97567719_PROTOCOL_V4.0_22Sep16.pdf
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
