Showing 7 ideas for tag "anticoagulation"

Goal 2: Reduce Human Disease

Need to assess a new method of warfarin management vs. new oral anticoagulants in patients with atrial fibrillation

The two obstacles to warfarin therapy (keeping the INR in range and the associated hassles of frequent lab visits) can be eliminated by INR self testing and online "virtual clinic" monitoring and management (as demonstrated in six small studies. Achieving an INR percent time in range of approximately 75% to 80% is associated with a 50% or lower rate of thromboembolism and major bleeding. The studies of new oral anticoagulants... more »

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

Details on the impact of addressing this CQ or CC

If the ease and convenience of INR self testing, when combined with online virtual clinic management, can double the safety and efficacy of warfarin therapy, this form of therapy will benefit millions of patients with atrial fibrillation world wide. By extrapolation, this mode of therapy may also benefit millions of patients at risk of venous thrombosis, myocardial infarction, and stroke.

Feasibility and challenges of addressing this CQ or CC

This issue would require a prospective randomized control trial in moderate to high risk patients with atrial fibrillation to compare warfarin managed with such a system vs treatment with one of the new oral anticoagulants. Additional issues could be addressed if the study also included a warfarin arm with traditional management and/or an arm that involved monitoring of the new agent. The projected impact of the new warfarin management method on a composite end point of stroke, systemic embolism, major bleed and death is large enough (30 to 60 fewer events per 1,000 patients per year) that the sample size would be much smaller than the trials used to evaluate the new agents vs warfarin in atrial fibrillation.

Name of idea submitter and other team members who worked on this idea Henry I. Bussey, Pharm.D.

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93 up votes
20 down votes
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Goal 2: Reduce Human Disease

Would patients with pulmonary arterial hypertension (PAH) benefit from background anticoagulation in addition to their PAH-targe

Pulmonary hypertension (PH) is a complex, progressive condition characterized by high blood pressure in the lungs. For several decades, oral anticoagulation has been recommended by some societies for patients with a specific form of PH called pulmonary arterial hypertension. However, the evidence currently supporting this recommendation is very limited. To date, no prospective randomized clinical trial has been completed... more »

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

Details on the impact of addressing this CQ or CC

The evolution of the anticoagulation recommendation in pulmonary arterial hypertension (PAH) is a relatively logical one at face value. Early in the modern era of PAH management, a “thrombosis” in the small pulmonary arteries was identified and described; studies since then have demonstrated hypercoagulability in patients with severe disease. Together, these observations led to a theory that in-situ thrombosis contributed to the PAH disease progression and a belief that anticoagulation should be beneficial. The empirical evidence currently supporting this recommendation comes mostly from a retrospective cohort study of the European COMPERA PH registry and a systematic review of 7 retrospective cohort studies that are at least 10 years old—2 of which did not suggest a survival benefit—and in a time where only 4 of the widely used PAH-targeted therapies were approved by the FDA. Purely based on observational evidence with a number of potential biases, warfarin (Coumadin) is widely used in PAH management to this day. Warfarin in this patient population is not without its risks, as some subgroups of PAH patients are at increased risk of bleeding complications based on their disease process alone. Assessing the true benefit of this widely used background therapy could allow clinicians and patients to more accurately weigh the risks and burden of anticoagulation with a true understanding of the survival benefit.

Feasibility and challenges of addressing this CQ or CC

Addressing this compelling question is indeed feasible through an NIH-sponsored randomized, double-blind, placebo-controlled trial of anticoagulation in patients with certain types of pulmonary arterial hypertension.

Name of idea submitter and other team members who worked on this idea Katherine Kroner, Michael Patrick Gray, PHA

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62 net votes
68 up votes
6 down votes
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Goal 1: Promote Human Health

Venous Thromboembolism

How can individual VTE risk-assessment scoring be combined with promising biomarker candidates in order to help predict risk in the general patient population and prevent unprovoked low-risk VTE cases?

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

Details on the impact of addressing this CQ or CC

The VTE field is approaching a new era of therapy in which predictive measures at the primary care level will identify those patients most at risk for VTE. With the identification of predictive biomarkers for VTE occurrence, efforts will be necessary to develop point-of-care or in-home biomarker testing devices to improve risk-assessment scoring and identification, so that patients could then be treated before progression. It will also be critical to accelerate risk-scoring systems that are beginning to incorporate biomarker candidates into the algorithm for use in clinical trials. Studies that will focus on correlating risk-assessment scores and biomarker research findings will provide a more accurate risk prediction and diagnostic value.

Name of idea submitter and other team members who worked on this idea Alice Kuaban on behalf of the American Society of Hematology (ASH)

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30 net votes
41 up votes
11 down votes
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Goal 2: Reduce Human Disease

Understand the Impact of Thrombosis in Children with Cancer

CC: Despite the potential impact that venous thrombotic events (VTE) have on children with cancer, several unresolved issues remain. To date, we are yet to understand:
- incidence/prevalence of VTE according to cancer type/staging
- ideal imaging modalities to diagnose/follow VTE
- thromboprophylaxis according to thrombosis risk stratification (development of VTE predictors)
- efficacy/safety to anticoagulate children... more »

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

Details on the impact of addressing this CQ or CC

Venous thrombotic events (VTE) are now occurring in 1/200 children admitted to a tertiary pediatric facility. In around 70-90% of cases, VTE occurs in children with an underlying condition, amongst which cancer represents up to 1/3 of patients. Within this group of patients, the thrombotic complications are associated with a higher morbidity (e.g. higher recurrence rates, high rate of CNS events in acute leukemia) and mortality. Nevertheless, the clinical challenges highlighted in the itemized Critical Challenge Section illustrate the lack of basic science, translational and clinical research available, as well as the paucity of evidence-based medicine recommendations necessary to acoount for the increasing number of patients with this complication.
On the other hand, pediatric oncology is one of the areas of pediatric care where the medical progresses of the last decades have drastically changed the natural history of cancer in children. In light of much higher survival rates for almost all types of pediatric cancer, the focus has now shifted towards decreasing treatment-related, as well as disease-related morbidities, increasing the quality of life of the many survivors. Because VTE is now recognized as one of the significant remaining complications within this patient population, addressing the list summarized herein would contribute to further improve the care of children with cancer.

Feasibility and challenges of addressing this CQ or CC

The infrastructure that is already in place under the Children's Oncology Group (COG), where almost any new clinical and/or translational idea related to the care of children with cancer becomes part of a clinical trial, could be rolled over to explore many of the items listed under the CC Section.
As a principle, VTE in children with cancer develop due to: a) host-related factors; b) chemotherapy/treatment-related factors; and c) disease-related issues. Therefore, protocol- and disease-specific studies could address, under the auspices of COG, the prevalence of VTE according to cancer type in a prospective manner. Similarly, high risk groups for VTE could be submitted to standardized imaging and/or biomarker investigation prospectivelly, in addition to collection of outcome data related to VTE and to anticoagulation protocols. Furthermore, tumor specimens/genetic markers could be evaluated and correlated to the study outcomes. The challenges of reaching consensus during protocol development would allow identification of equipoise for certain clinical scenarios, obviating the need of trials, or the use of consensus techniques, before diagnostic/therapeutic protocols could be adopted.
In conclusion, the develoment of a multidisciplinary task force (i.e. pediatric radiologists, oncologists, hematologists, molecular biology experts), which, for the most part, is already in place (i.e. COG), would be instrumental to foster research on this extremely clinically relevant area.

Name of idea submitter and other team members who worked on this idea Leonardo R. Brandao, MD, MSc;

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30 net votes
38 up votes
8 down votes
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Goal 2: Reduce Human Disease

Venous Thromboembolism

There is a great need for the development and evaluation of biomarkers for the study of venous thromboembolism (VTE) pathophysiology and risk assessment.

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

Details on the impact of addressing this CQ or CC

Recent efforts to evaluate biomarkers for VTE occurrence and recurrence have led to the identification of multiple potential candidates, including P-selectin, E-selectin, D-dimer, various microparticles, and various inflammatory cytokines. However, no specific biomarker has yet emerged for routine clinical use for individual VTE risk stratification and personal targeted therapeutics. The development of improved animal models will advance the study of VTE pathophysiology, allowing for more accurate evaluation of emerging biomarkers and initial assessments of potential advanced therapeutic interventions. Also, the identification and prioritization of novel VTE biomarkers will be needed to help improve our understanding of the molecular mechanisms underlying VTE, so as to shepherd the development of novel mechanisms of therapy beyond anticoagulation.

Name of idea submitter and other team members who worked on this idea Alice Kuaban on behalf of the American Society of Hematology (ASH)

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13 net votes
26 up votes
13 down votes
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Goal 2: Reduce Human Disease

Restoring Balance to Stroke Prevention in Older AFib Patients

Improving Tools for Anticoagulation Decision-Making

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

Details on the impact of addressing this CQ or CC

AFib increases stroke risk by five-fold and doubles the risk that a stroke will result in permanent disability. While oral anticoagulation (OAC) is highly effective at reducing stroke risk, elderly patients are often under-anticoagulated. This is in part due to an under-appreciation of the stroke risk associated with AFib and the tendency of some health care professionals to prioritize perceived bleeding risk over stroke prophylaxis. Because current bleeding risk assessment tools are imperfect and largely unable to predict patients who are likely to have bleeding complications, they are often not utilized—or if used, do not truly predict which patients are at risk of a bleed. An improved bleeding risk tool is critical to improved risk assessment in the elderly. That bleeding risk tool should then be combined with the stroke risk tool for single risk stratification to streamline anticoagulation decision-making.

Feasibility and challenges of addressing this CQ or CC

Developing effective integrated risk assessment tools is feasible only if there is consensus on the validity of the clinical information being provided. The approach to this critical challenge is two-fold. First, needed research that improves the reliability of bleeding risk assessment in the elderly should be pursued. Second, stroke and bleeding risk tools should be combined into a single risk stratification tool. This will require significant investment and focus, but the resulting bleeding risk assessment combined with the accepted CHA2DS2-VASc score, would significantly impact the 40 - 60% of patients who are currently not on an anticoagulant and are at increased risk of stroke and death.

Name of idea submitter and other team members who worked on this idea AFib Optimal Treatment Task Force

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11 net votes
19 up votes
8 down votes
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Goal 3: Advance Translational Research

Preventing Stroke from Atrial Fibrillation

How can health systems develop and implement validated measurement and feedback tools to identify patients with atrial fibrillation, categorize their risk factors for stroke, capture reasons for non-treatment, and develop interventions customized to those reasons to substantially improve the proportion of patients receiving effective oral anticoagulant stroke prevention treatment?

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

Details on the impact of addressing this CQ or CC

Registries show that only about half of patients with atrial fibrillation and risk for stroke are taking oral anticoagulants. Given 4 million Americans with atrial fibrillation, half of whom (2 million) are not treated, with 5% stroke rate per year, 67% of which can be prevented, there are 67000 strokes occuring in this untreated population per year in the US. Assuming half of these could be treated if programs were develped that were proven effective, this would result in 33,000 strokes prevented per year.

Feasibility and challenges of addressing this CQ or CC

NIH funds are needed to address the complex set of health system, psychosocial, and health IT issues to answer this question. Atrial fibrillation is a common condition with patients presenting and being treated accross various parts of the health care system. Small programs have shown promise for the use of the electronic health record to systematically identify patients with atrial fibrillation, but health system leadership needs evidence of success and guidance before this will be possible on a broad scale. With evidence of feasibility and impact, performance measures may be developed that would substantially enhance adaptation.

Name of idea submitter and other team members who worked on this idea Chris Granger

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6 net votes
8 up votes
2 down votes
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