# Hemorrhage control in the irreversible anticoagulated patient

> **NIH NIH R01** · MAYO CLINIC ARIZONA · 2020 · $577,027

## Abstract

Project Summary/Abstract
Hemorrhage in a setting of anticoagulation (ACA) is a serious medical emergency associated with high
morbidity and mortality. Patients on ACA for mechanical valves or cardiac assist devices (CAD) and who are
bleeding are at even greater risk because ACA reversal may not be possible in these patients. These patients
are typically considered to be high-risk for open surgical repair and are more commonly treated today by
endovascular approaches. For example, gastrointestinal bleeding (GIB), one of the most common forms of
internal hemorrhage and life-threatening medical emergencies seen in the ACA patient today, affects
approximately 500,000 patients annually in the US. In fact, studies have shown that up to 40% develop GIB
following CAD implant (AA). The rate of mortality drastically increases from 10% to 40% if bleeding occurs
during a hospitalization for another illness, especially when complicated by ACA. Over the past 30 years, open
surgical treatment of GIB has been largely replaced by minimally invasive endovascular interventions. This
approach involves delivery of metallic coils spanning the bleeding site; these coils induce thrombosis to
occlude the vessel. However, there are significant drawbacks to coil embolization; most important is recurrent
bleeding or persistent bleeding in anticoagulated and in coagulopathy patients who are unable to produce a
thrombus. When re-bleeding or break-through bleeding occurs following coil embolization, risk of mortality
increases 10-fold (6). We hypothesize that by using a cutting-edge off-the-shelf injectable hemostatic
biomaterial, we can reduce morbidity/mortality; and for the first time, we can treat bleeding patients that are on
anticoagulation or are coagulopathic (i.e., disseminated intravascular coagulation (DIC)). Our novel approach
uses a universal shear-thinning biomaterial (STB) that creates an impenetrable cast of the bleeding vessel
without relying on thrombosis for efficacy. In this proposal, we will further optimize the three candidate STB
formulations (Aim 1), test them in in vitro and ex vivo artery models (Aim 2) and finally evaluate the
performance of the STBs in the anticoagulated porcine models of embolization (Aim 3).

## Key facts

- **NIH application ID:** 9905407
- **Project number:** 5R01HL137193-04
- **Recipient organization:** MAYO CLINIC ARIZONA
- **Principal Investigator:** Rahmi Oklu
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $577,027
- **Award type:** 5
- **Project period:** 2017-06-01 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9905407

## Citation

> US National Institutes of Health, RePORTER application 9905407, Hemorrhage control in the irreversible anticoagulated patient (5R01HL137193-04). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9905407. Licensed CC0.

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