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

> **NIH NIH K23** · SETON HEALTHCARE · 2021 · $64,260

## Abstract

Project Summary/Abstract
 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 enroll in 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.

## Key facts

- **NIH application ID:** 10404778
- **Project number:** 3K23HL127227-05S1
- **Recipient organization:** SETON HEALTHCARE
- **Principal Investigator:** Truman Milling
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $64,260
- **Award type:** 3
- **Project period:** 2016-09-01 → 2022-03-09

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10404778

## Citation

> US National Institutes of Health, RePORTER application 10404778, A Patient Centered Approach to Restarting Oral Anticoagulant Therapy After Major Hemorrhage (3K23HL127227-05S1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10404778. Licensed CC0.

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