# Anticoagulant use, safety, and effectiveness for venous thromboembolism prevention in inflammatory bowel disease patients

> **NIH NIH R00** · VANDERBILT UNIVERSITY MEDICAL CENTER · 2024 · $249,000

## Abstract

PROJECT SUMMARY/ABSTRACT
There is a profound need to improve venous thromboembolism [VTE] treatment and prevention, particularly in
patients with inflammatory bowel disease [IBD]. This Pathway to Independence Award application is submitted
by a pharmacoepidemiologist committed to improving VTE prevention and treatment in populations who are
often excluded or vastly under-represented in randomized clinical trials [RCTs]. Of the 3 million Americans
affected by IBD, ~1–7% will develop VTE, a significant source of morbidity and mortality, in both the outpatient
and inpatient settings. While attention has been paid to the role of anticoagulants for VTE prevention in IBD
patients, there are key barriers to prescribing anticoagulants in this population including: (1) absence of data
on the effectiveness of anticoagulants for the prevention of VTE in IBD patients; (2) fear of bleeding
complications; and (3) lack of evidence on the safety of anticoagulants in high-risk subgroups such as patients
with active disease flares or postpartum IBD patients, who are at an increased risk of adverse complications.
The overarching goal of this research is to evaluate the use, effectiveness, and safety of anticoagulants in IBD
patients in the inpatient and outpatient settings. The applicant will achieve the proposed aims of this K99/R00
award under the guidance of established researchers who span the disciplines of epidemiology, biostatistics,
gastroenterology, and hematology at the University of Pennsylvania. First, the applicant will use a combination
of machine learning and advanced methodological techniques to examine predictors of use, effectiveness, and
safety of anticoagulants in the inpatient setting (K99 phase). In the R00 phase, the applicant will use linked
electronic health records/claims database to examine the comparative effectiveness and safety of direct oral
anticoagulants, warfarin, and heparins in IBD patients in the outpatient setting. The research proposed in this
K99/R00 is critical since it provides timely needed information on the risks and benefits of anticoagulants in
IBD patients, data that will not be forthcoming from large RCTs in the foreseeable future. The proposed career
development and training goals will provide the applicant with training in predictive modeling, time-varying
adjustment, and machine learning. The successful completion of the proposed training, infrastructure, and
institutional support at the University of Pennsylvania will guarantee the applicant's success and transition to
scientific independence.

## Key facts

- **NIH application ID:** 10893637
- **Project number:** 5R00HL159230-04
- **Recipient organization:** VANDERBILT UNIVERSITY MEDICAL CENTER
- **Principal Investigator:** Ghadeer k. Dawwas
- **Activity code:** R00 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $249,000
- **Award type:** 5
- **Project period:** 2023-08-01 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10893637

## Citation

> US National Institutes of Health, RePORTER application 10893637, Anticoagulant use, safety, and effectiveness for venous thromboembolism prevention in inflammatory bowel disease patients (5R00HL159230-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10893637. Licensed CC0.

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