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Goal 2: Reduce Human Disease

Evidence based approaches to Red Blood Cell transfusion

What are the optimal RBC transfusion thresholds for adult and pediatric cancer patients undergoing chemotherapy regimens that may improve functional status and quality of life?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

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Cancer patients undergo intensive medical and surgical therapies to treat their underlying disease. Treatment commonly results in anemia requiring RBC and platelet transfusions to support the patient through the hypoproliferative phase of chemotherapy. This is particularly true for those patients requiring hematopoetic stem cell transplantation (HSCT). Following therapy, cancer outpatients commonly receive RBC transfusions for weeks to months to maintain their functional status.

Common causes of death in patients with hematological malignancies and other cancers are infections and bleeding. A meta-analysis of clinical trials suggested that liberal transfusion is associated with greater risk of infection. Conversely, restrictive transfusion could adversely affect quality of life and functional status in oncology populations. In addition, pre-clinical and clinical studies support that concomitant anemia and thrombocytopenia significantly compound bleeding risk, and that hemostasis can be optimized in thrombocytopenia by maintaining a higher hematocrit. Although bleeding risks in relation to platelet transfusion thresholds are well studied in patients with hematological malignancy, optimal hemoglobin levels in thrombocytopenic patients are not known. Despite the significant allocation of blood components to cancer patients as a whole, RBC transfusion practices are not well studied within this group.

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Randomized controlled clinical trials and other studies investigating optimal transfusion thresholds and other measures of practice are required to provide health care providers with evidence to guide one of the most common therapies administered in the setting of malignancy. The clinically important end points of well-designed studies could include: 1) quality of life and functional status for both inpatients and outpatients; 2) neurocognitive development in pediatric populations; 3) bleeding events / bleeding scores; 4) impact on immunity including immunomodulation and infection; 5) reconstitution of hematopoiesis; and 6) survival and/or recurrence of disease.. Besides a generalizable study population, certain target populations of interest are those with high risk disease, HSCT patients, patients undergoing radiation therapy, and pediatric patients.

There are >1.6 million new cases of cancer annually in the USA, including >50,000 with leukemia and >6,000 with HSCT. Cancer therapies are rapidly advancing in the era of genomics and immunotherapy. Capitalizing on the tradition of research in cancer, single and multicenter studies of RBC transfusion are feasible using randomized controlled designs in conjunction with clinical trials of chemotherapeutic regimens. The results of these studies will impact a large patient population’s quality of life, and may ultimately impact healthcare cost and blood demand.

Name of idea submitter and other team members who worked on this idea Nareg Roubinian, MD and Naomi Luban, MD for the 2015 NHLBI State of the Science in Transfusion Medicine

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Goal 2: Reduce Human Disease

Adequately powered clinical trials

Pragmatic and adequately powered clinical trials are an ongoing challenge.

­Develop new tools to facilitate identification and recruitment of subjects, remote/wireless data collection, and functional measures.

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Critical Challenge (CC)

Name of idea submitter and other team members who worked on this idea Society for Vascular Surgery

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Goal 2: Reduce Human Disease

The 'other' circulation system - the lymphatic system needs the attention the blood circulation system receives.

Much is still unknown about the lymphatic system. No medical specialist owns it. NHLBI and NCI could work together on understanding lymphatic disease in the direction of understanding how metastasis spreads disease. NHLBI can help by establishing a unit to organize research interest in such an important body system in health and disease.

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Understanding the lymphatic system and how metastasis facilitates it as a highway to spread disease could save many lives.

Feasibility and challenges of addressing this CQ or CC

There are several lymphatic diseases such as lymphangiomatosis - which are complex and systemic - through the study of which, we can learn the role the lymphatic system plays in disease - beyond the well-known essential functions of fat absorption, the immune response and in maintaining fluid balance.

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Goal 2: Reduce Human Disease

Reducing Variability in Outcomes from Out of Hospital Cardiac Arrest

Out of hospital cardiac arrest remains a major cause of mortality in the United States and there is a large variability in survival within communities. We need to better understand the reasons for this variability which include patient, event, EMS system and care processes and work as a nation to reduce the variability but adopting best practices and actively addressing the barriers to change which can be social, cultural,... more »

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Critical Challenge (CC)

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If we could reduce variability, we would save more lives and also enhance the chain of survival in our communities

Feasibility and challenges of addressing this CQ or CC

will require that we connect multiple parts of the community including the population at risk, public health services and the health care system which is not always easy in silo systems or fragmented health care systems

Name of idea submitter and other team members who worked on this idea Mohamud Daya

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