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

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

Contact information

Prof Johnson Miriam
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 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(s)	Health Research Authority, Yorkshire & The Humber - Leeds West Research Ethics Committee, 17/03/2016, ref: 16/YH/0045
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
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
Overall study end 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
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
Recruitment start date	06/06/2016
Recruitment end date	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

Northern Ireland Hospice

Newtownabbey
BT37 9RH
United Kingdom

Marie Curie Hospice

1A Kensington Rd
Belfast
BT5 6NF
United Kingdom

Macmillan Unit

Antrim
BT36 4TS
United Kingdom

Marie Curie Hospice

Bridgeman Rd
Penarth
Cardiff
CF11 9LJ
United Kingdom

Sponsor information

University of Hull
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