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A Patient Centered Approach to Restarting Oral Anticoagulant Therapy After Major Hemorrhage

Award Number: K23HL127227
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 09/01/2016
PERIOD OF PERFORMANCE END DATE: 03/09/2022

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A Patient Centered Approach to Restarting Oral Anticoagulant Therapy After Major Hemorrhage - DESCRIPTION (provided by applicant): Major hemorrhage on anticoagulants is a dramatic presentation that creates a bias against restarting the anticoagulant for fear of precipitating another hemorrhage. What often gets lost in this one-sided assessment of risk is the underlying threat of thromboembolic disease, for which the patient was anticoagulated to begin with. A more balanced approach between the risk of hemorrhage and stroke and prospective randomized data on which to base it is direly needed. This proposal is relevant to the mission of NHLBI as it deals with heart disease, since the most common indication for oral anticoagulation is atrial fibrillation. It deals with blood disease, albeit an iatrogenic coagulopathy caused by anticoagulation therapy. It deals with the clinical setting of bleeding, both in gastrointestinal bleeding and intracranial hemorrhage. It aims to enhance the health of patients with these diseases by studying the risk/benefit of restarting anticoagulation after major hemorrhage. Its goals are immediately translational into clinical practice. It fosters training and mentoring of an emerging scientist and physician, and it creates and supports a robust, collaborative research infrastructure in partnership with the private non-profit Seton Healthcare Family and the new University of Texas Dell Medical School in Austin. There are no evidence-based guidelines on when to restart warfarin after major hemorrhage, much less the Novel Oral Anticoagulants (NOACs) increasingly being used. The overall goal of this application is to elucidate a research plan to inform the clinical decision to restart anticoagulation after major hemorrhage that will establish Dr. Milling as an independent impactful researcher in this field. Dr. Milling will enrollin a formal master's degree program: Masters of Science in Clinical Investigations at the University of Texas Health Science Center - San Antonio. He will also undergo extensive and immersive training in hemostasis and coagulation, the design and conduct of multicenter clinical trials, conceptual training in the field of adaptive trial design, and health economics. Dr. Milling will receive careful mentorship from Drs. Steven Warach, Scott Berry Todd Olmstead and Jerrold Levy utilizing both formal training curriculum and informal meeting frameworks to draw from their extensive and diverse experience and guidance. Dr. Milling will conduct a three-phased research design, including the development of a National Practice Survey Tool for Clinical Trials (survey of patients, PCPs, and Cardiologists), laying the ground work for a larger multicenter, adaptive, "time dose" clinical trial and a future R01 submission, to find the ideal time to restart oral anticoagulants after a major hemorrhage that balances the risk of recurrent hemorrhage with the risk of thromboembolic disease.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2020	ASCENSION SETON	1345 PHILOMENA ST	AUSTIN	TX	78723	TRAVIS	USA	Blood Diseases and Resources Research	000	5	10/11/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $64,260 )
2021	2021	ASCENSION SETON	1345 PHILOMENA ST	AUSTIN	TX	78723	TRAVIS	USA	Blood Diseases and Resources Research	001	5	9/9/2021	SUPPLEMENT FOR EXPANSION	$64,260
2021	2020	ASCENSION SETON	1345 PHILOMENA ST	AUSTIN	TX	78723	TRAVIS	USA	Blood Diseases and Resources Research	000	5	9/9/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $64,260

Issue Date FY: 2020 ( Subtotal = $131,220 )
2020	2020	ASCENSION SETON	1345 PHILOMENA ST	AUSTIN	TX	78723	TRAVIS	USA	Blood Diseases and Resources Research	000	5	8/26/2020	NON-COMPETING CONTINUATION	$131,220
														Subtotal = $131,220

Issue Date FY: 2019 ( Subtotal = $134,460 )
2019	2019	ASCENSION SETON	1345 PHILOMENA ST	AUSTIN	TX	78723	TRAVIS	USA	Blood Diseases and Resources Research	000	4	8/30/2019	NON-COMPETING CONTINUATION	$134,460
														Subtotal = $134,460

Issue Date FY: 2018 ( Subtotal = $135,659 )
2018	2018	SETON FAMILY OF HOSPITALS	1345 PHILOMENA ST	AUSTIN	TX	78723	TRAVIS	USA	Blood Diseases and Resources Research	000	3	8/16/2018	NON-COMPETING CONTINUATION	$135,659
														Subtotal = $135,659

Issue Date FY: 2017 ( Subtotal = $163,715 )
2017	2017	SETON FAMILY OF HOSPITALS	1345 PHILOMENA ST	AUSTIN	TX	78723	TRAVIS	USA	Blood Diseases and Resources Research	000	2	8/4/2017	NON-COMPETING CONTINUATION	$163,715
														Subtotal = $163,715

Issue Date FY: 2016 ( Subtotal = $134,651 )
2016	2016	SETON HEALTHCARE	1345 PHILOMENA STREET	AUSTIN	TX	78723	TRAVIS	USA	Blood Diseases and Resources Research	000	1	8/29/2016	NEW	$134,651
														Subtotal = $134,651

Grand Total All Awards = $763,965

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A Patient Centered Approach to Restarting Oral Anticoagulant Therapy After Major Hemorrhage

Award Number: K23HL127227

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 09/01/2016

PERIOD OF PERFORMANCE END DATE: 03/09/2022

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