Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays

NCT03685097 | Completed FDA Device

• 1 other identifier: HEMCS-013
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests in cardiac surgery patients. In addition the association of Quantra-derived parameters with select platelet function tests will be investigated.

Conditions

Coagulation Disorder

Outcome Measures

Primary Outcomes (4)

• Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta results

  Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta

  Baseline (before surgery)

• Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta

  Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta

  After cardiac bypass (10 minutes after administration of protamine)

• Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results

  Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests

  Baseline (before surgery)

• Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results

  Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests

  After cardiac bypass (10 minutes after administration of protamine)

Secondary Outcomes (2)

• Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest

  Baseline (before surgery)

• Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest

  After cardiac bypass (10 minutes after administration of protamine)

Study Arms (1)

Cardiac surgery patients

Patients undergoing elective cardiac surgery requiring cardiopulmonary bypass.

Diagnostic Test: Quantra System with the QPlus Cartridge

Interventions

Quantra System with the QPlus Cartridge DIAGNOSTIC_TEST

Point-of-care viscoelastic testing

Cardiac surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes subjects 18 years or older undergoing cardiac surgery with cardiopulmonary bypass.

You may qualify if:

• Subject is \>18 years
• Subject is undergoing elective cardiac surgery with cardiopulmonary bypass
• Subject is willing to participate and has signed a consent form

You may not qualify if:

• Subject is younger than 18 years
• Subject has known congenital coagulopathy
• Subject is unable to provide written informed consent

Sponsors & Collaborators

• HemoSonics LLC: lead
• IRCCS Policlinico S. Donato: collaborator

Study Sites (1)

IRCCS Policlinico San Donato

Milan, Italy

Location

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Marco Ranucci, MD

  IRCCS Policlinico San Donato (Milan) Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 26, 2018
• Study Start: March 1, 2018
• Primary Completion: July 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 26, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)