Recruiting

PCM vs. ROTEM

Sponsor:

Entegrion, Inc.

Code:

NCT03679286

Conditions

Hemostasis Monitoring

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PCM and ROTEM

Study Details

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

Conditions

Hemostasis Monitoring

Study ID

NCT03679286

Start date

Aug 20, 2018

Status verified date

Apr, 2020

Completion date

Mar 31, 2021

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

All subjects

No intervention

Interventions

PCM and ROTEM

Test of blood sample by both PCM and ROTEM

Primary outcome measure

  • Method comparison: Deming regression analysis (PCM and ROTEM NATEM) [ Time Frame: Parameter differences assessed at time of blood sampling ]

Central Contacts and Locations

Central contacts

Chris Lindsell, PhD

919.536.1500chris.lindsell@vumc.org

Entegrion

919.536.1500shammonds@entegrion.com

Locations

Washington University in St. Louis

Recruiting

Saint Louis, Missouri, United States, 63110

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

More Information

Sponsor

Entegrion, Inc.

Last update posted

Apr 16, 2020

Last verified

Apr, 2020

Keywords

  • Coagulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Entegrion, Inc. on 2020-04-16.