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Quantra vs TEG for Congenital Cardiac Surgery - a Pilot Validation Study

NCT05295693 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-05-13

No results posted yet for this study

Summary

Congenital heart surgery on cardio-pulmonary bypass (CPB) is associated with impacted coagulation quality and increased bleeding after separation of CPB.

The current testing device used at our institution is the "TEG 5000" (Haemonetics Corporation). The novel coagulation testing device "Quantra System" (Hemosonics) has favorable properties (result within 20 minutes) allowing for a quicker identification of the coagulation problem and hence faster administration of the correct coagulation products, potentially leading to better coagulation quality and possibly reducing the need of additional blood products. The aim of this prospective observational (non-interventional, investigational only) quality improvement study is to investigate if the Quantra is reliable and valid in predicting the coagulation status when compared with our standard-of-care device TEG 5000.

Conditions

  • Coagulopathy

Interventions

DEVICE

Correlation of the Quantra with the TEG

The purpose of this study is to evaluate the efficacy/reliability/validity of the Quantra device in patients with congenital heart disease for cardiac surgery on CPB. The study if of investigational interest only. No clinical decisions will be made based on the results obtained by the Quantra device.

Sponsors & Collaborators

Principal Investigators

  • Alexander R Schmidt, MD · Stanford University

Eligibility

Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-13
Primary Completion
2023-05-25
Completion
2023-05-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05295693 on ClinicalTrials.gov