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

Comparative Analysis of the Entegrion Point of Care Coagulation Monitor (PCM) With ROTEM in the Measurement of Viscoelastic Coagulation Parameters

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

Study Overview

• Status: Unknown
• Conditions: Hemostasis Monitoring
• Intervention / Treatment: Device: PCM and ROTEM

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University in St. Louis
      • Contact: Clinical Research Nurse
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Completed
      • Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University
      • Contact: Clinical Research Nurse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients who have a medical management need that requires measurement of their hemostasis status or are at risk of being hypocoagulable or hypercoagulable

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All subjects; No intervention	Device: PCM and ROTEM; Test of blood sample by both PCM and ROTEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Method comparison: Deming regression analysis (PCM and ROTEM NATEM)	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)	Parameter differences assessed at time of blood sampling

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Method comparison: Deming regression analysis (PCM and ROTEM INTEM, EXTEM)	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)	Parameter differences assessed at time of blood sampling
Correlation between abnormalities	Correlation between abnormalities as assessed by conventional coagulation assays (such as fibrinogen concentration, CBC, PT, PTT, INR), vital signs, demographics or trauma (if any)	Parameter differences assessed at time of blood sampling

Collaborators and Investigators

• Sponsor: Entegrion, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2018
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): March 31, 2021

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 18, 2018
• First Posted (ACTUAL): September 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Coagulation
• Other Study ID Numbers: PCM-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No