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
1 other identifier
observational
120
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2018
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 20, 2018
CompletedFirst Submitted
Initial submission to the registry
August 30, 2018
CompletedFirst Posted
Study publicly available on registry
September 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedApril 16, 2020
April 1, 2020
2.4 years
August 30, 2018
April 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Method comparison: Deming regression analysis (PCM and ROTEM INTEM, EXTEM)
Parameter differences assessed at time of blood sampling
Correlation between abnormalities
Parameter differences assessed at time of blood sampling
Study Arms (1)
All subjects
No intervention
Interventions
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Previous enrollment in study
- Incarcerated
- Heparin infusion in prior 24 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Entegrion, Inc.lead
Study Sites (3)
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Ohio State University
Columbus, Ohio, 43210, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2018
First Posted
September 20, 2018
Study Start
August 20, 2018
Primary Completion
December 31, 2020
Study Completion
March 31, 2021
Last Updated
April 16, 2020
Record last verified: 2020-04