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CoagulopathyNCT05295693

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

An observational study of Coagulopathy, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages Up to 8 years
Conditions the study is for
Coagulopathy
What is being tested?
Correlation of the Quantra with the TEG
Type of treatment
Medical device
How many people
40 participants
Where
1 siteUnited States
Study dates
13 Oct 2022to 25 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: All patients with congenital heart disease scheduled for cardiac surgery on cardio-pulmonary bypass at our institution Age range is 0 to 8 years. There are no enrollment restrictions related to gender or ethnic background.

Who may be able to join

  • All cases with hypothermia (<=30C)

Who cannot join

  • Neonatal/Infant Bloodless surgery
  • Bodyweight under 3kg

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Palo Alto, California, 94305

Other trials in United States

About this study

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

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.

Read the detailed description

Congenital heart surgery on cardio-pulmonary bypass (CPB) is associated with impacted coagulation quality and increased bleeding after separation of CPB. Therefore, coagulation products and blood products often need to be given/transfused during these cases. The correct choice and dosing of coagulation products is essential to effectively stop bleeding and reduce the need of additional blood transfusion.

The current testing device used at our institution during congenital heart surgery on CPB is the TEG 5000 (Haemonetics Corporation). Prior to separation from CPB (mostly 30-60 minutes) and after the first coagulation products were given (approx. 60 minutes after separation from CPB) a Clauss Fibrinogen and a TEG are drawn. These samples are sent to an off-site lab for processing and time to result ranges from 60-90 minutes. Therefore, results are often not present when needed.

An easy to use point-of-care (POC) test device being readily available in the operation room and allowing for rapid results could result in quicker identification of the coagulation problem and hence allow for faster administration of the correct coagulation products, potentially leading to better coagulation quality and possibly reducing the need of additional blood products.

The Quantra System (Hemosonics) is an easy-to-use, stand-alone device presenting results within 20 minutes. With these properties all above mentioned problems would be addressed. To date the Quantra has not been used and has not been evaluated in patients with congenital heart disease for cardiac surgery on CPB.

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

All patients who are enrolled in this study will be patients who are scheduled to undergo cardiac surgery and who require a general anesthesia, endotracheal intubation, arterial line placement and coagulation testing as part of standard of care for the surgery.

No patient will have a general anesthesia, endotracheal intubation, arterial line inserted or coagulation testing for research purposes only.

If the family/patient consent to be enrolled in the study the patient will be included in the study. It is standard of care to draw blood samples for coagulation testing (TEG and Clauss Fibrinogen) prior to separation of cardio-pulmonary-bypass (t1) and after the first coagulation products were given (t2), resulting in 2 x 5.4mL of blood.

For testing of efficacy/reliability/validity of the Quantra System we will need to draw additional blood samples (2.7mL) for each time point t1 and t2, resulting in a total of 2 x 2.7mL. These extra 5.4mL of blood drawn during the research portion of this study is additional to what they need for the surgical procedure and is not standard of care.

No clinical decision will be made on the results of the Quantra System. This is an investigational, non-interventional study.

Conditions
Coagulopathy
Being tested
Correlation of the Quantra with the TEG
Medical subject headings
Hemostatic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Correlation of the Quantra with the TEGDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation Quantra vs TEG_Fibrinogen_Function1

    Correlation/Linear regression/normal_vs_abnormal of Quantra (FCS) with TEG (K time \& alpha angle)

    Measured: 30 minutes during anesthesia, prior to separation from CPB

  2. Correlation Quantra vs TEG_Fibrinogen_Function1

    Correlation/Linear regression/normal_vs_abnormal of Quantra (FCS) with TEG (K time \& alpha angle)

    Measured: 30 minutes during anesthesia, after coagulation products were given

  3. Correlation Quantra vs TEG_Fibrinogen_Function2

    Correlation/Linear regression/normal_vs_abnormal of Quantra (FCS) with Clauss Fibrinogen.

    Measured: 30 minutes during anesthesia, prior to separation from CPB

  4. Correlation Quantra vs TEG_Fibrinogen_Function2

    Correlation/Linear regression/normal_vs_abnormal of Quantra (FCS) with Clauss Fibrinogen.

    Measured: 30 minutes during anesthesia, after coagulation products were given

  5. Correlation Quantra vs TEG_Platelet_Function

    Correlation/Linear regression/normal_vs_abnormal of Quantra (CS/PCS) with TEG (MA)

    Measured: 30 minutes during anesthesia, prior to separation from CPB

  6. Correlation Quantra vs TEG_Platelet_Function

    Correlation/Linear regression/normal_vs_abnormal of Quantra (CS/PCS) with TEG (MA)

    Measured: 30 minutes during anesthesia, after coagulation products were given

  7. Correlation Quantra vs TEG_clot initiation

    Correlation/Linear regression/normal_vs_abnormal of Quantra (CT/CTH) with TEG (R time)

    Measured: 30 minutes during anesthesia, prior to separation from CPB

  8. Correlation Quantra vs TEG_clot initiation

    Correlation/Linear regression/normal_vs_abnormal of Quantra (CT/CTH) with TEG (R time)

    Measured: 30 minutes during anesthesia, after coagulation products were given

  9. Correlation Quantra vs TEG_clot strength/firmness

    Correlation/Linear regression/normal_vs_abnormal of Quantra (CS) with TEG (G value)

    Measured: 30 minutes during anesthesia, prior to separation from CPB

  10. Correlation Quantra vs TEG_clot strength/firmness

    Correlation/Linear regression/normal_vs_abnormal of Quantra (CS) with TEG (G value)

    Measured: 30 minutes during anesthesia, after coagulation products were given

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start13 Oct 2022
  3. Primary completion25 May 2023
  4. Study completion25 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05295693
Sponsor's protocol ID
Quantra vs TEG
Status last verified
May 2025
First submitted
28 Feb 2022
Last updated
13 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Ochocinski D, Navaratnam M, Babb A, De Souza E, Kamra K, Sleasman JR, Margetson TD, Bhamidipati JK, Ramamoorthy C, Schmidt AR. Comparison of the Point-Of-Care Coagulation Device Quantra With the TEG-5000 for Congenital Cardiac Surgery-A Pilot Study. Paediatr Anaesth. 2025 Jun;35(6):469-480. doi: 10.1111/pan.15097. Epub 2025 Mar 17.

    PubMed 40095320

Questions about this trial

What is this clinical trial studying?

An observational study of Coagulopathy, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation Quantra vs TEG_Fibrinogen_Function1 (time frame: 30 minutes during anesthesia, prior to separation from CPB). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05295693, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.

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