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

• Conditions: Hemostasis Monitoring
• Interventions: Device: PCM and ROTEM

• Registration Number: NCT03679286
• Lead Sponsor: Entegrion, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-08-20
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-16
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All subjects	PCM and ROTEM	No intervention

Primary Outcome Measures

Name	Time	Method
Method comparison: Deming regression analysis (PCM and ROTEM NATEM)	Parameter differences assessed at time of blood sampling	Deming regression will be used to compare the PCM and the ROTEM NATEM assay (which reports clotting time, speed of clot formation, maximal clot firmness and clot lysis)

Secondary Outcome Measures

Name	Time	Method
Correlation between abnormalities	Parameter differences assessed at time of blood sampling	Correlation between abnormalities as assessed by conventional coagulation assays (such as fibrinogen concentration, CBC, PT, PTT, INR), vital signs, demographics or trauma (if any)
Method comparison: Deming regression analysis (PCM and ROTEM INTEM, EXTEM)	Parameter differences assessed at time of blood sampling	Deming regression will be used to compare the PCM and the ROTEM INTEM and EXTEM assays (which both report clotting time, speed of clot formation, maximal clot firmness and clot lysis)

Trial Locations

Locations (3)

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States