Comparative Analysis of PCM With ROTEM in the Measurement of Viscoelastic Coagulation Parameters

Entegrion

Status: Unknown

Conditions: Hemostasis Monitoring

Treatments: Device: PCM and ROTEM

Study type: Observational

Funder types: Industry

Identifiers

NCT03679286

PCM-002

Details and patient eligibility

About

To determine if PMC viscoelastic coagulation parameters correlate with those generated by a marketed device in adult patients who require hemostasis monitoring or who are at risk of bleeding or thrombotic indications

Full description

The primary aim of this study is a performance evaluation of the PCM coagulation monitor in comparison to the ROTEM thromboelastometry system.

To include a measurement of the entire range of the test system, subjects with a medical management need that requires the measurement of their hemostasis status (such as PT/PTT, INR) or are at risk for being hypo-coagulable or hyper-coagulable will be included in this study.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• In opinion of investigator, absence of anything that precludes subject from being good study candidate
• Informed consent
• Order for measurement of hemostasis status of patients who are at risk for being hyper-coagulable or hypo-coagulable due to clinical diagnosis or medical need

Exclusion criteria

• Previous enrollment in study
• Incarcerated
• Heparin infusion in prior 24 hours

Trial design

120 participants in 1 patient group

All subjects

Description:

No intervention

Treatment:

Device: PCM and ROTEM