# Improving Anticoagulation Monitoring in Pediatric Patients: Use of a Microfluidic Platform to Test Low Volume Blood Samples Obtained by Heel-Stick Collection

> **NIH NIH R44** · BAEBIES, INC. · 2020 · $214,063

## Abstract

ABSTRACT
 Improving Anticoagulation Monitoring in Pediatric Patients: Use of a Microfluidic Platform to Test Low Volume
 Blood Samples Obtained by Heel-Stick Collection
Children treated for congenital heart defects or other disorders of hypercoagulation are prescribed unfractionated
heparin (UFH) or low molecular weight heparin (LMWH) throughout surgical treatment; they may be prescribed
heparin for up to 2 weeks post-surgery to prevent thrombosis. UFH is a fiscally efficient, effective anticoagulant
that should be closely monitored over time to ensure proper dosage and patient response; LMWH is a newer
anticoagulant that is gaining traction among cardiologists. Despite the need for constant monitoring of heparin
levels, sometimes every 4 hours, there are limitations to currently available systems hindering delivery of optimal
heparin level results to physicians. These barriers include individual assays that use relatively large volumes of
blood (~2 mL per assay) and long turnaround times between measurements (up to 2 hours) that limit the utility
of these tests for appropriate dosing, especially in the beginning of anticoagulation therapy. In addition,
commonly utilized assays (partial thromboplastin time (PTT), activated PTT (aPTT), and prothrombin time) show
poor correlation to heparin levels infused in patients, but are still in use due to their historical value and wide
adoption in the field. More rapid and accurate methods are needed to assess heparin levels that reduce the
overall amount of blood and provide physicians with sufficient dosing information to deliver optimal therapy to
pediatric patients.
Through a previously funded NIH Fast-Track project, we developed a novel and scalable platform to assess and
monitor heparin therapy administered to pediatric patients through measurement of Factor Xa (FXa) and Anti-
thrombin III (ATIII) levels. In response to input from key opinion leaders, we are developing a third assay for
aPTT. This assay panel is run on our near-patient digital microfluidic (DMF) platform using 50 L of whole blood
input. The fluorescent assays use nanoliter volumes of sample and reagents on a disposable single-use
cartridge. Although the platform has been developed and feasibility has been demonstrated with the assays,
much work remains for this product to be commercially ready. Funding through this Commercialization
Readiness Pilot (CRP) will support studies to establish reliable reagent and cartridge manufacturing processes,
preclinical studies to validate the manufacturing processes, and development of the FDA regulatory strategy for
a full multi-site clinical method comparison study.
Our approach is strengthened by our continued partnership with Boston Children’s Hospital, the high potential
clinical impact of the tests, and thorough analysis and global distributor relationships demonstrating a significant
market gap. The DMF heparin monitoring product will fill a critical gap in pediatric care by providing an
ine...

## Key facts

- **NIH application ID:** 10080472
- **Project number:** 2R44HL140662-04
- **Recipient organization:** BAEBIES, INC.
- **Principal Investigator:** VAMSEE K. PAMULA
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $214,063
- **Award type:** 2
- **Project period:** 2018-02-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10080472

## Citation

> US National Institutes of Health, RePORTER application 10080472, Improving Anticoagulation Monitoring in Pediatric Patients: Use of a Microfluidic Platform to Test Low Volume Blood Samples Obtained by Heel-Stick Collection (2R44HL140662-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10080472. Licensed CC0.

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