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 in | BMJ open Vol. 13; no. 9; p. e073049 |
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Main Authors | , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
England
BMJ Publishing Group LTD
05.09.2023
BMJ Publishing Group |
Series | Protocol |
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Online Access | Get full text |
ISSN | 2044-6055 2044-6055 |
DOI | 10.1136/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. |
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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 |
AuthorAffiliation_xml | – name: 1 College of Biomedical and Life Sciences , Cardiff University , Cardiff , UK – name: 2 Population Medicine , Cardiff University , Cardiff , UK – name: 7 Public Involvement , Health and Care Research Wales , Cardiff , UK – name: 5 Aneurin Bevan University Health Board , Newport , UK – name: 6 University of Exeter Medical School , Exeter , UK – name: 3 Velindre University NHS Trust , Cardiff , UK – name: 4 University Hospital of Wales , Cardiff and Vale University Health Board , Cardiff , 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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Keywords | PALLIATIVE CARE Thromboembolism PREVENTIVE MEDICINE |
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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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