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

ClinicalTrials.gov ID: NCT05295693

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Official title

Comparison of the Point-of-care Coagulation Device Quantra With the TEG for Congenital Cardiac Surgery - a Pilot Validation Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05295693
Recruitment status: Completed
Study type: Observational
Phase: Not listed
Lead sponsor: Stanford University; Other
Enrollment: 40 participants

Conditions and interventions

Conditions

Coagulopathy

Interventions

Correlation of the Quantra with the TEG Device

Device

Eligibility (public fields only)

Age range: Up to 8 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 13, 2022 (Actual)
Primary completion: May 25, 2023 (Actual)
Completion: May 25, 2023 (Actual)
Last update posted: May 13, 2025

2022 – 2023

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Stanford University	Palo Alto	California	94305	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05295693, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 13, 2025 · Synced Nov 15, 2026