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

NCT05295693 | Completed FDA Device

• 1 other identifier: Quantra vs TEG
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (10)

• Correlation Quantra vs TEG_Fibrinogen_Function1

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

  30 minutes during anesthesia, prior to separation from CPB

• Correlation Quantra vs TEG_Fibrinogen_Function1

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

  30 minutes during anesthesia, after coagulation products were given

• Correlation Quantra vs TEG_Fibrinogen_Function2

  Correlation/Linear regression/normal\_vs\_abnormal of Quantra (FCS) with Clauss Fibrinogen.

  30 minutes during anesthesia, prior to separation from CPB

• Correlation Quantra vs TEG_Fibrinogen_Function2

  Correlation/Linear regression/normal\_vs\_abnormal of Quantra (FCS) with Clauss Fibrinogen.

  30 minutes during anesthesia, after coagulation products were given

• Correlation Quantra vs TEG_Platelet_Function

  Correlation/Linear regression/normal\_vs\_abnormal of Quantra (CS/PCS) with TEG (MA)

  30 minutes during anesthesia, prior to separation from CPB

• Correlation Quantra vs TEG_Platelet_Function

  Correlation/Linear regression/normal\_vs\_abnormal of Quantra (CS/PCS) with TEG (MA)

  30 minutes during anesthesia, after coagulation products were given

• Correlation Quantra vs TEG_clot initiation

  Correlation/Linear regression/normal\_vs\_abnormal of Quantra (CT/CTH) with TEG (R time)

  30 minutes during anesthesia, prior to separation from CPB

• Correlation Quantra vs TEG_clot initiation

  Correlation/Linear regression/normal\_vs\_abnormal of Quantra (CT/CTH) with TEG (R time)

  30 minutes during anesthesia, after coagulation products were given

• Correlation Quantra vs TEG_clot strength/firmness

  Correlation/Linear regression/normal\_vs\_abnormal of Quantra (CS) with TEG (G value)

  30 minutes during anesthesia, prior to separation from CPB

• Correlation Quantra vs TEG_clot strength/firmness

  Correlation/Linear regression/normal\_vs\_abnormal of Quantra (CS) with TEG (G value)

  30 minutes during anesthesia, after coagulation products were given

Interventions

Correlation of the Quantra with the TEG DEVICE

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.

Eligibility Criteria

• Age: Up to 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• All cases with hypothermia (\<=30C)

You may not qualify if:

• Neonatal/Infant Bloodless surgery
• Bodyweight under 3kg

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 40095320 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 x 2.7mL of full blood for coagulation testing with the Quantra System. Blood samples will not be stored or used for other testing.

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexander R Schmidt, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 25, 2022
• Study Start: October 13, 2022
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)