Novel Broad-Spectrum Point-of-Care Coagulometer
新型广谱护理点凝血计
基本信息
- 批准号:10707617
- 负责人:
- 金额:$ 106.88万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-09-01 至 2025-08-31
- 项目状态:未结题
- 来源:
- 关键词:Accident and Emergency departmentActivated Partial Thromboplastin Time measurementAddressAnticoagulantsAnticoagulationAntiphospholipid SyndromeBiological AssayBloodBlood Coagulation DisordersBlood PlateletsBlood coagulationBlood specimenCaringCitratesClassificationClinicClinicalClinical TrialsCoagulation ProcessCytolysisDetectionDevelopmentDevicesDiagnosticDiseaseDocumentationDoseEmergency SituationEmergency treatmentEventF8 geneFactor VFactor XIFibrinFibrinolytic AgentsFunctional disorderFutureGene MutationGlassGoalsHealth Care CostsHealth ProfessionalHemophilia AHemorrhageHospitalsHyperhomocysteinemiaInheritedInpatientsLabelLightLiver diseasesLow-Molecular-Weight HeparinManualsMarketingMeasurementMeasuresMedicalMedical DeviceMethodsMicrofluidicsMonitorNormal RangeOperative Surgical ProceduresOralOutcomeOutpatientsPathway interactionsPatient CarePatientsPharmaceutical PreparationsPharmacy facilityPhase III Clinical TrialsPhysiciansPlasmaPoint of Care TechnologyProcessProtein C DeficiencyProtein S DeficiencyProthrombinRecombinantsReference ValuesResearchRiskSalesSamplingScheduleSchemeSiliconSurfaceSurrogate EndpointTechnologyTestingTherapeuticThrombinTimeVenousVitamin K DeficiencyWhole BloodWorkbiomarker developmentclinical developmentcommercializationfundamental researchgene therapyhealthy volunteerimprovedinhibitornew technologynovelpatient screeningpoint of carepotential biomarkerresponserestorationroutine caretemporal measurementtransmission processvolunteervon Willebrand Disease
项目摘要
Project Summary/Abstract
Work under this proposal supports development of a broad-spectrum point-of-care (POC) coagulometer by
Perosphere Technologies (The Perosphere Technologies POC Coagulometer) with the intent to create and offer
an automated, microfluidic version of the manual Lee/White clotting time method. The device is based on novel
technology and utilizes reagent-less, single-use microfluidic cuvettes made of silicon and glass for measurement
of blood samples. Clot activation occurs at the beginning of the intrinsic clotting pathway through contact of a
blood sample with the inner glass and silicon surfaces of the cuvette. The device detects clot formation by
monitoring the intensity of near-infrared light, transmitted through cuvette and blood sample, and sensing of fibrin
assembly at the end of the common clotting pathway. The clot detection scheme affords development of two
main assays, a Clotting Time Assay, that measures the time to onset of clot formation and is currently
implemented on the coagulometer platform, and a Clot Lysis Time assay, that measures the time to onset of
subsequent clot breakdown and is in development. Research indicates that the device is broadly sensitive to
the effects of anticoagulants across drug class, their reversal agents and thrombolytic drugs. Initial marketing
efforts will focus on use of the device with implemented Clotting Time assay for monitoring of the direct oral
anticoagulants (DOACs) and low molecular weight heparins (LMWHs). Research under this proposal targets
establishment of clotting time reference ranges for healthy volunteers and patients on the DOACs rivaroxaban,
apixaban, dabigatran and edoxaban, in direct support of initial marketing goals. In support of future device
applications, the research also targets assessment of the device’s ability to detect inherited or acquired
coagulopathies, based on abnormal clotting times, as well as assessment of the device’s sensitivity to
abelacimab, a novel anticoagulant and direct factor XI/XIa inhibitor, currently in clinical development.
Perosphere Technologies intends to commercialize the device through a marketing, sales and distribution
partnership with a global medical device company. The device is similarly suited for use in emergency situations
(e.g. emergency room, emergency vehicle) and for routine care in the inpatient and outpatient settings (hospitals,
clinics, surgical suites, doctor’s offices, pharmacies) by healthcare professionals who can perform or order fresh
venous whole blood draws. The device promises to address several unmet medical needs, including point-of-
care monitoring of DOACs, and has the potential to define new standards of care. The device is expected to
improve patient care, clinical outcome and to reduce healthcare costs, by providing physicians with the means
to make faster and better-informed treatment decisions. The developed Clotting Time and Clot Lysis Time
assays will present a new way to describe a patient’s coagulation state and enable opportunities for fundamental
research of disease mechanisms and therapeutic approaches.
项目总结/文摘
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Stefan Frank Zappe其他文献
Stefan Frank Zappe的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}