Heart and Blood Diseases

All Conditions

Digestive System Diseases

Blood and Lymph Conditions

Thrombosis

Liver Diseases

Thrombophilia

Embolism

Embolism and Thrombosis

Vascular Diseases

Hematologic Diseases

Gastrointestinal Diseases

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Hematinics

Heparin

Enoxaparin

Liver Extracts

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Enoxaparin sodium

Patients in the extended thromboprophylaxis group will receive Redesca (enoxaparin sodium for injection) (40mg) once a day, starting on the day of surgery, for 90 days postoperatively.

Patients in the standard of care group will receive Fragmin (daletparin) (5,000 I.U) once a day, starting on the day or surgery, for 30 days postoperatively.

Redesca is low molecular weight heparin and a biosimilar biologic drug (biosimilar) to Lovenox. Indications have been granted on the basis of similarity between Redesca and the reference biologic drug Lovenox. As such, Redesca (enoxaparin sodium) is indicated for thromboprophylaxis in patients undergoing high risk abdominal and colorectal surgeries. Doses are provided as self-administered subcutaneous injections using a pre-filled syringe with a protective shield.

Redesca (enoxaparin sodium for injection)

Fragmin is a low molecular weight heparin indicated for thromboprophylaxis in patients undergoing high risk abdominal and colorectal surgeries. Doses are provided as self-administered subcutaneous injections using a pre-filled syringe with a protective shield. Our institution uses this drug for standard of care thromboprophylaxis (30 days) in this patient population.

Fragmin (dalteparin)

Crystal Engelage, PhD

Anton Skaro, MD PhD

This clinical trial will investigate the ability of thromboelastrogrpahy (TEG®) to detect hypercoagulability after liver surgery and will examine the effect of extended thromboprophylaxis (medical treatment to prevent the development of blood clots inside blood vessels) in patients undergoing liver surgery for cancer treatment.

The liver plays a key role in regulating the process of blood clotting. As a result, blood clots are a major cause of complications and death following liver surgery. This is especially true in cancer patients who are at a higher risk of developing blood clots. Current methods for preventing clotting complications after liver surgery include conventional coagulation blood tests (CCTs) and anticoagulant drugs, such as low molecular weight heparins (LMWHs). Current LMWH treatment is prescribed for one month after surgery, but studies show that the risk of developing blood clots can last up to 3 months. Studies also show that CCTs may not be as effective in detecting clotting issues as more comprehensive testing systems, such as TEG. This study will randomize 50 participants to receive 90 days of thromboprophylaxis (using the LMWH Redesca) or the standard of care 30 days (using the LMWH Fragmin) after liver surgery. The medication will be given by injection, similar to a regular vaccine or an insulin injection. Participants will inject the medication every day, for 30 or 90 days, after surgery. Participants will also have their blood tested for clotting issues via TEG testing before surgery and on post-operative days 1,3,5,30 and 90. After surgery, participants will be monitored by their surgeon for clotting complications and 3 year disease-free survival.

This will be a phase III pilot trial where 50 participants will be randomized 1:1 to receive extended duration thromboprophylaxis via Redesca or standard of care thromboprophylaxis via Fragmin. Participants will be followed for 3 years after surgery.

Prolonged Hypercoagulability Following Major Liver Resection for Malignancy

Not planning to share IPD with other researchers

All participants will have postoperative TEG testing performed for the detection of hypercoagulability.

Determining the occurrence of postoperative venous thrombotic events between treatment groups

Comparing disease free survival (DFS) rates between treatment groups

Valeo Pharma Inc

Western University, Canada

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Symptoms and General Pathology

Kidney Diseases

Stroke

Heart Diseases

Lung Diseases

Sepsis

Toxemia

Neurodegenerative Diseases

Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.

Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.

Active Intervention

Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.

Usual Care

Marie A Bakitas, DNSc

Rural patients with life-limiting illness are at very high risk of not receiving appropriate care due to a lack of health professionals, long distances to treatment centers, and limited palliative care (PC) clinical expertise. Secondly, although culture strongly influences people's response to diagnosis, illness and treatment preferences, culturally-based care models are not currently available for most seriously-ill rural patients and their family caregivers. Lack of sensitivity to cultural differences may compromise PC for minority patients. The purpose of this study is to compare a culturally-based Tele-consult program to usual hospital care to determine whether a culturally-based PC Tele-consult program leads to lower symptom burden in hospitalized African American and White older adults with a life-limiting illness.

The triple threat of rural geography, racial inequities, and older age hinders access to high quality PC for a significant proportion of Americans. Rural patients with life-limiting illness are at very high risk of not receiving appropriate care due to a lack of health professionals, long distances to treatment centers, and limited PC clinical expertise. Although culture strongly influences people's response to diagnosis, illness and treatment preferences, culturally-based care models are not currently available for most seriously-ill rural patients and their family caregivers. Lack of sensitivity to cultural differences may compromise PC for minority patients. The two major public health consequences of these problems are:

1. Access-Rural patients have sub-optimal or no access to PC. Despite significant nationwide growth, access to PC is grossly inadequate for the 60 million US citizens who live in rural or non-metropolitan areas. There is low PC use in rural and minority populations. As a result, rural patients experience significant suffering from uncontrolled symptoms that PC expertise could alleviate.
2. Acceptability-Even when palliative and hospice services are available, African Americans (AA), compared to Whites (W) are more likely to receive medically-ineffective, poor quality care due to a culturally-insensitive health care system and mistrust of health care providers. Making culturally competent PC available for diverse underserved and rural Americans is a national priority.

This community-developed, culturally based Teleconsult Intervention specifically targets the gaps of PC access and acceptability. It was developed by and for rural, Deep South AA and W patients and providers, and uses state-of-the-art telehealth methods, to provide PC consultation to hospitalized seriously-ill patients and family. Using National Consensus Project guidelines, and the culturally-based, community-developed PC Tele-consult intervention, a remote PC expert conducts a comprehensive PC patient assessment, in collaboration with local providers. Following interdisciplinary PC team review, the remote clinician communicates recommendations. Two additional structured follow up contacts at Day 3 and 6 ensure care coordination and smooth transitions that enable patients to receive guideline concurrent PC in their communities.

Aims of the study and Hypotheses:

Primary Aim: Determine whether a culturally-based PC Tele-consult program leads to lower symptom burden in hospitalized AA and W older adults with a life-limiting illness.

Hypothesis 1: Intervention patient participants receiving a culturally-based PC Tele-consult program will experience lower symptom burden on Day 7 post-consultation.

Secondary Aim: Determine whether a culturally-based PC Tele-consult program results in higher patient and caregiver quality of life, care satisfaction, and lower caregiver burden at Day 7 post-consultation, and lower resource use (hospital readmission, emergency visits) 30-days post-discharge.

Hypothesis 2: Intervention participants and their caregivers receiving a culturally-based PC Tele-consult program will experience higher patient and caregiver quality of life, care satisfaction, lower caregiver burden at Day 7 post consultation, and lower resource use (e.g. hospital admission, emergency visits) at 30 days after discharge.

Exploratory Aim: Explore mediators and moderators of patient symptom and caregiver burden outcomes.

A Culturally-Based Palliative Care Tele-consult Program for Rural Southern Elders

A Community Developed, Culturally-Based Palliative Care Tele-Consult Program for African American and White Rural Southern Elders With a Life Limiting Illness

Patient symptom burden measured by Edmonton Symptom Assessment Scale \[ESAS\] mediated and/or moderated by hospitalist/clinician implementation of palliative care recommendations. Implementation of palliative care recommendations are measured using Electronic Health Record \[eHR\] documentation of recommendations by hospitalist/clinician at Day 7. Each item in the ESAS is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90.

Patient symptom burden measured by Edmonton Symptom Assessment Scale \[ESAS\] mediated and/or moderated by patient/caregiver implementation of palliative care recommendations. Patient/caregiver implementation of palliative care recommendations are measured using patient/caregiver report at Day 7. Each item in the Edmonton Symptom Assessment Scale \[ESAS\] is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90.

Caregiver burden measured by Montgomery Borgatta Caregiver Burden Scale \[MBCB\] mediated and/or moderated by hospitalist/clinician implementation of palliative care recommendations. Implementation of palliative care recommendations are measured using Electronic Health Record \[eHR\] documentation of recommendations by hospitalist/clinician at Day 7. This scale contains a total of 14 questions and 5 Likert scale responses (a lot less, a little less, the same, a little more, or a lot more). Caregiver burden will be quantified by three subscales; objective, subjective and demand burdens. Objective burden is measured by 6 questions (total score between 0-30), subjective burden is measured by 4 questions (total score between 4-20), and demand burden is measured by 4 questions (total score between 4-20).

Caregiver burden measured by Montgomery Borgatta Caregiver Burden Scale \[MBCB\] mediated and/or moderated by caregiver/patient implementation of palliative care recommendations. Caregiver/patient implementation of palliative care recommendations are measured using caregiver/patient report at Day 7. This scale contains a total of 14 questions and 5 Likert scale responses (a lot less, a little less, the same, a little more, or a lot more). Caregiver burden will be quantified by three subscales; objective, subjective and demand burdens. Objective burden is measured by 6 questions (total score between 0-30), subjective burden is measured by 4 questions (total score between 4-20), and demand burden is measured by 4 questions (total score between 4-20).

Caregiver evaluation of end-of-life care quality measured by Caregiver Evaluation of Quality of End-of-Life Care \[CEQUEL\]

Caregiver bereavement measured by Caregiver Bereavement Items (\[CBI\]

Change from baseline in patient-reported symptom burden measured using the Edmonton Symptom Assessment Scale (ESAS) at baseline; change from baseline measured using the ESAS at 7 days post-baseline. Each item is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90.

Change from baseline in family-reported satisfaction with care measured using the FAMCARE-2 scale at baseline; change from baseline measured using FAMCARE-2 at 7 days post-baseline. Each item is scored using: vs (very satisfied), s (satisfied), u (undecided), d (dissatisfied), vd (very dissatisfied), or NA (not applicable).

Change from baseline in patient-reported quality of life using the Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS Global Health-10) at baseline; change from baseline measured using the PROMIS Health-10 at 7 days post-baseline. Items 1-6 are scored using: 1-5 (1=poor; 5=excellent). Item 7 is scored using 1-5 (1= not at all; 5= completely). Item 8 is scored using 1-5 (1= always; 5=never). Item 9 is scored using 1-5 (1=very severe; 5=none). Item 10 is scored using 0-10 (0=no pain; 10=worst pain imaginable).

Change from baseline in caregiver-reported quality of life using the Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS Global Health-10) at baseline; change from baseline measured using the PROMIS Global Health-10 at 7 days post-baseline. Items 1-6 are scored using: 1-5 (1=poor; 5=excellent). Item 7 is scored using 1-5 (1= not at all; 5= completely). Item 8 is scored using 1-5 (1= always; 5=never). Item 9 is scored using 1-5 (1=very severe; 5=none). Item 10 is scored using 0-10 (0=no pain; 10=worst pain imaginable).

Change from baseline in caregiver-reported burden using the Montgomery Borgatta Caregiver Burden Scale (MBCB) at baseline; change from baseline measured using the MBCB at 7 days post-baseline. This scale contains a total of 14 questions and 5 Likert scale responses (a lot less, a little less, the same, a little more, or a lot more). Caregiver burden will be quantified by three subscales; objective, subjective and demand burdens. Objective burden is measured by 6 questions (total score between 0-30), subjective burden is measured by 4 questions (total score between 4-20), and demand burden is measured by 4 questions (total score between 4-20).

Patient resource use (e.g., number of hospital readmissions, number of hospital days, number of ICU days, number of Emergency Department \[ED\] visits, and hospice days during the 30 days following discharge) will be collected via electronic health records (eHR) 30 days post-discharge.

Change from baseline in patient-reported satisfaction with care using the Feeling Heard and Understood questionnaire at baseline; change from baseline using the Feeling Heard and Understood questionnaire at 7 days post-baseline. Likert scale using: completely, quite a bit, moderately, slightly, not at all.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prolonged Hypercoagulability Following Major Liver Resection for Malignancy	NCT06153394	Hepatic Disease Surgery-Complic... Hypercoagulabil... Thrombosis	Redesca (enoxap... Fragmin (daltep...	18 Years -	Western University, Canada
A Culturally-Based Palliative Care Tele-consult Program for Rural Southern Elders	NCT03767517	Cancer Cardiac Disease Pulmonary Disea... Neuro-Degenerat... Renal Disease Stroke Sepsis Hepatic Disease	Active Interven... Usual Care	55 Years -	University of Alabama at Birmingham
Prolonged Hypercoagulability Following Major Liver Resection for Malignancy	NCT06153394	Hepatic Disease Surgery-Complic... Hypercoagulabil... Thrombosis	Redesca (enoxap... Fragmin (daltep...	18 Years -	Western University, Canada

Spots Global Cancer Trial Database for hepatic disease