Condition category
Circulatory System
Date applied
01/06/2016
Date assigned
15/07/2016
Last edited
24/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

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

Cohort observational

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 on-going assessments, have died, or have been discharged, up to a maximum of 3 weeks' inpatient stay.

Intervention type

Not Specified

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

Sponsor information

Organisation

University of Hull

Sponsor details

Cottingham Road
Hull
HU6 7RX
United Kingdom

Sponsor type

University/education

Website

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

Editorial Notes

24/11/2016: Internal review. 26/07/2016: Participant information sheet uploaded