HIDDEN2: Study protocol for the hospital deep vein thrombosis detection study in patients with cancer receiving palliative care

Medical patients, admitted acutely to hospital, are at risk of venous thromboembolism (VTE). Clinical guidelines advise thromboprophylaxis prophylaxis for those at high risk of VTE. VTE is a common sequela of cancer, but guidelines take little consideration of cancer as an independent risk factor an...

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Published inBMJ open Vol. 13; no. 9; p. e073049
Main Authors Kitson, Terri, Osborne, Emma, Noble, Simon, Pease, Nikki, Alikhan, Raza, Bryant, Catherine, Groves, Tristan, Wallace, Rebecca, Walker, Sarah, Seddon, Kathy, Smith, Deb, Raisanen, Lawrence, Smith, Joanna, Thomas, Ian, Upton, Laura, Casbard, Angela
Format Journal Article
LanguageEnglish
Published England BMJ Publishing Group LTD 05.09.2023
BMJ Publishing Group
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ISSN2044-6055
2044-6055
DOI10.1136/bmjopen-2023-073049

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Abstract Medical patients, admitted acutely to hospital, are at risk of venous thromboembolism (VTE). Clinical guidelines advise thromboprophylaxis prophylaxis for those at high risk of VTE. VTE is a common sequela of cancer, but guidelines take little consideration of cancer as an independent risk factor and their utility in palliative care patients is unclear. The hospice inpatient deep vein thrombosis (DVT) detection study (HIDDen) reported a 28% prevalence of asymptomatic iliofemoral DVT in hospice patients of poor performance status (PS) and prognosis, calling into question the utility of thromboprophylaxis in the palliative care setting. However, the majority of cancer inpatients receiving palliative care are admitted to hospital through the acute medical setting, yet their risk factors for VTE may differ from those admitted to hospices. To better understand the prevalence and behaviours of VTE in patients with cancer receiving palliative care who are admitted as an acute medical emergency. Multicentre, observational cohort study. Secondary care acute hospitals in South Wales, UK. We plan to recruit 232 patients≥18 years old with a diagnosis of incurable cancer, and/or receiving palliative or best supportive care who are admitted acutely to hospital. Patients will be followed up for a maximum of 6 months following registration. Presence of lower extremity DVT. Symptom burden attributed to DVT or pulmonary embolism, patient PS, patient demographics and development of new VTE within 90 days of registration. The study statistical analysis plan will document analysis, methodology and procedures. Ethical approval was obtained from the Wales Research Ethics Committee, reference 22/WA/0037 (IRAS 306352)-the main trial results will be analysed as soon as practically possible and the publication shared with investigators and on sponsor website; applications to access trial data will be subject to sponsor review process.
AbstractList IntroductionMedical patients, admitted acutely to hospital, are at risk of venous thromboembolism (VTE). Clinical guidelines advise thromboprophylaxis prophylaxis for those at high risk of VTE. VTE is a common sequela of cancer, but guidelines take little consideration of cancer as an independent risk factor and their utility in palliative care patients is unclear. The hospice inpatient deep vein thrombosis (DVT) detection study (HIDDen) reported a 28% prevalence of asymptomatic iliofemoral DVT in hospice patients of poor performance status (PS) and prognosis, calling into question the utility of thromboprophylaxis in the palliative care setting. However, the majority of cancer inpatients receiving palliative care are admitted to hospital through the acute medical setting, yet their risk factors for VTE may differ from those admitted to hospices.ObjectiveTo better understand the prevalence and behaviours of VTE in patients with cancer receiving palliative care who are admitted as an acute medical emergency.DesignMulticentre, observational cohort study.SettingSecondary care acute hospitals in South Wales, UK.PatientsWe plan to recruit 232 patients≥18 years old with a diagnosis of incurable cancer, and/or receiving palliative or best supportive care who are admitted acutely to hospital. Patients will be followed up for a maximum of 6 months following registration.Primary outcomePresence of lower extremity DVT.Secondary outcomesSymptom burden attributed to DVT or pulmonary embolism, patient PS, patient demographics and development of new VTE within 90 days of registration.AnalysisThe study statistical analysis plan will document analysis, methodology and procedures.Ethics and disseminationEthical approval was obtained from the Wales Research Ethics Committee, reference 22/WA/0037 (IRAS 306352)—the main trial results will be analysed as soon as practically possible and the publication shared with investigators and on sponsor website; applications to access trial data will be subject to sponsor review process.
Medical patients, admitted acutely to hospital, are at risk of venous thromboembolism (VTE). Clinical guidelines advise thromboprophylaxis prophylaxis for those at high risk of VTE. VTE is a common sequela of cancer, but guidelines take little consideration of cancer as an independent risk factor and their utility in palliative care patients is unclear. The hospice inpatient deep vein thrombosis (DVT) detection study (HIDDen) reported a 28% prevalence of asymptomatic iliofemoral DVT in hospice patients of poor performance status (PS) and prognosis, calling into question the utility of thromboprophylaxis in the palliative care setting. However, the majority of cancer inpatients receiving palliative care are admitted to hospital through the acute medical setting, yet their risk factors for VTE may differ from those admitted to hospices. To better understand the prevalence and behaviours of VTE in patients with cancer receiving palliative care who are admitted as an acute medical emergency. Multicentre, observational cohort study. Secondary care acute hospitals in South Wales, UK. We plan to recruit 232 patients≥18 years old with a diagnosis of incurable cancer, and/or receiving palliative or best supportive care who are admitted acutely to hospital. Patients will be followed up for a maximum of 6 months following registration. Presence of lower extremity DVT. Symptom burden attributed to DVT or pulmonary embolism, patient PS, patient demographics and development of new VTE within 90 days of registration. The study statistical analysis plan will document analysis, methodology and procedures. Ethical approval was obtained from the Wales Research Ethics Committee, reference 22/WA/0037 (IRAS 306352)-the main trial results will be analysed as soon as practically possible and the publication shared with investigators and on sponsor website; applications to access trial data will be subject to sponsor review process.
Introduction Medical patients, admitted acutely to hospital, are at risk of venous thromboembolism (VTE). Clinical guidelines advise thromboprophylaxis prophylaxis for those at high risk of VTE. VTE is a common sequela of cancer, but guidelines take little consideration of cancer as an independent risk factor and their utility in palliative care patients is unclear. The hospice inpatient deep vein thrombosis (DVT) detection study (HIDDen) reported a 28% prevalence of asymptomatic iliofemoral DVT in hospice patients of poor performance status (PS) and prognosis, calling into question the utility of thromboprophylaxis in the palliative care setting. However, the majority of cancer inpatients receiving palliative care are admitted to hospital through the acute medical setting, yet their risk factors for VTE may differ from those admitted to hospices.Objective To better understand the prevalence and behaviours of VTE in patients with cancer receiving palliative care who are admitted as an acute medical emergency.Design Multicentre, observational cohort study.Setting Secondary care acute hospitals in South Wales, UK.Patients We plan to recruit 232 patients≥18 years old with a diagnosis of incurable cancer, and/or receiving palliative or best supportive care who are admitted acutely to hospital. Patients will be followed up for a maximum of 6 months following registration.Primary outcome Presence of lower extremity DVT.Secondary outcomes Symptom burden attributed to DVT or pulmonary embolism, patient PS, patient demographics and development of new VTE within 90 days of registration.Analysis The study statistical analysis plan will document analysis, methodology and procedures.Ethics and dissemination Ethical approval was obtained from the Wales Research Ethics Committee, reference 22/WA/0037 (IRAS 306352)—the main trial results will be analysed as soon as practically possible and the publication shared with investigators and on sponsor website; applications to access trial data will be subject to sponsor review process.
Medical patients, admitted acutely to hospital, are at risk of venous thromboembolism (VTE). Clinical guidelines advise thromboprophylaxis prophylaxis for those at high risk of VTE. VTE is a common sequela of cancer, but guidelines take little consideration of cancer as an independent risk factor and their utility in palliative care patients is unclear. The hospice inpatient deep vein thrombosis (DVT) detection study (HIDDen) reported a 28% prevalence of asymptomatic iliofemoral DVT in hospice patients of poor performance status (PS) and prognosis, calling into question the utility of thromboprophylaxis in the palliative care setting. However, the majority of cancer inpatients receiving palliative care are admitted to hospital through the acute medical setting, yet their risk factors for VTE may differ from those admitted to hospices.INTRODUCTIONMedical patients, admitted acutely to hospital, are at risk of venous thromboembolism (VTE). Clinical guidelines advise thromboprophylaxis prophylaxis for those at high risk of VTE. VTE is a common sequela of cancer, but guidelines take little consideration of cancer as an independent risk factor and their utility in palliative care patients is unclear. The hospice inpatient deep vein thrombosis (DVT) detection study (HIDDen) reported a 28% prevalence of asymptomatic iliofemoral DVT in hospice patients of poor performance status (PS) and prognosis, calling into question the utility of thromboprophylaxis in the palliative care setting. However, the majority of cancer inpatients receiving palliative care are admitted to hospital through the acute medical setting, yet their risk factors for VTE may differ from those admitted to hospices.To better understand the prevalence and behaviours of VTE in patients with cancer receiving palliative care who are admitted as an acute medical emergency.OBJECTIVETo better understand the prevalence and behaviours of VTE in patients with cancer receiving palliative care who are admitted as an acute medical emergency.Multicentre, observational cohort study.DESIGNMulticentre, observational cohort study.Secondary care acute hospitals in South Wales, UK.SETTINGSecondary care acute hospitals in South Wales, UK.We plan to recruit 232 patients≥18 years old with a diagnosis of incurable cancer, and/or receiving palliative or best supportive care who are admitted acutely to hospital. Patients will be followed up for a maximum of 6 months following registration.PATIENTSWe plan to recruit 232 patients≥18 years old with a diagnosis of incurable cancer, and/or receiving palliative or best supportive care who are admitted acutely to hospital. Patients will be followed up for a maximum of 6 months following registration.Presence of lower extremity DVT.PRIMARY OUTCOMEPresence of lower extremity DVT.Symptom burden attributed to DVT or pulmonary embolism, patient PS, patient demographics and development of new VTE within 90 days of registration.SECONDARY OUTCOMESSymptom burden attributed to DVT or pulmonary embolism, patient PS, patient demographics and development of new VTE within 90 days of registration.The study statistical analysis plan will document analysis, methodology and procedures.ANALYSISThe study statistical analysis plan will document analysis, methodology and procedures.Ethical approval was obtained from the Wales Research Ethics Committee, reference 22/WA/0037 (IRAS 306352)-the main trial results will be analysed as soon as practically possible and the publication shared with investigators and on sponsor website; applications to access trial data will be subject to sponsor review process.ETHICS AND DISSEMINATIONEthical approval was obtained from the Wales Research Ethics Committee, reference 22/WA/0037 (IRAS 306352)-the main trial results will be analysed as soon as practically possible and the publication shared with investigators and on sponsor website; applications to access trial data will be subject to sponsor review process.
Author Kitson, Terri
Osborne, Emma
Wallace, Rebecca
Noble, Simon
Groves, Tristan
Raisanen, Lawrence
Seddon, Kathy
Upton, Laura
Pease, Nikki
Alikhan, Raza
Casbard, Angela
Walker, Sarah
Smith, Joanna
Thomas, Ian
Bryant, Catherine
Smith, Deb
AuthorAffiliation 1 College of Biomedical and Life Sciences , Cardiff University , Cardiff , UK
7 Public Involvement , Health and Care Research Wales , Cardiff , UK
2 Population Medicine , Cardiff University , Cardiff , UK
4 University Hospital of Wales , Cardiff and Vale University Health Board , Cardiff , UK
3 Velindre University NHS Trust , Cardiff , UK
5 Aneurin Bevan University Health Board , Newport , UK
6 University of Exeter Medical School , Exeter , UK
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– name: 6 University of Exeter Medical School , Exeter , UK
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/37669841$$D View this record in MEDLINE/PubMed
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CitedBy_id crossref_primary_10_1016_j_tru_2024_100196
crossref_primary_10_4081_btvb_2024_125
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Keywords PALLIATIVE CARE
Thromboembolism
PREVENTIVE MEDICINE
Language English
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Johnson (2023090508400732000_13.9.e073049.8) 2014; 48
Noble (2023090508400732000_13.9.e073049.2) 2010; 102 Suppl 1
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Snippet Medical patients, admitted acutely to hospital, are at risk of venous thromboembolism (VTE). Clinical guidelines advise thromboprophylaxis prophylaxis for...
IntroductionMedical patients, admitted acutely to hospital, are at risk of venous thromboembolism (VTE). Clinical guidelines advise thromboprophylaxis...
Introduction Medical patients, admitted acutely to hospital, are at risk of venous thromboembolism (VTE). Clinical guidelines advise thromboprophylaxis...
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SubjectTerms Adolescent
Anticoagulants
Clinical medicine
Consent
Hospices
Hospitals
Humans
Inpatients
Medical prognosis
Neoplasms
Observational Studies as Topic
Palliative Care
Patients
Prostate
Registration
Skin cancer
Thromboembolism
Thrombosis
Ultrasonic imaging
Veins & arteries
Venous Thromboembolism
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Title HIDDEN2: Study protocol for the hospital deep vein thrombosis detection study in patients with cancer receiving palliative care
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Volume 13
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