Biological and Clinical Relevance of Quantra Viscoelastic Hemostatic Assay in Hemorrhagic Cardiac Surgery

NCT07105904 | Completed FDA Device

• 1 other identifier: IRB 00010254 - 2025 - 065
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to assess the correlation between Quantra viscoelastometric assay and laboratory hemostasis biology in a cardiac surgery cohort presenting with acute hemorrhage in the operating room. The main questions it aims to answer are:

• is Quantra a valuable surrogate for hemostasis biology in the setting of bleeding cardiac surgery?
• are Quantra parameters well correlated with tranfusion thresholds in the setting of bleeding cardiac surgery?

Conditions

Hemorrhage; Cardiac Surgery; Hemorrhagic Shock

Keywords

hemmorhage; hemorrhagic cardiac surgery; Quantra; viscoelastometric assay; cardiac surgery

Outcome Measures

Primary Outcomes (3)

• Correlation of Quantra with Prothrombin Time and Activated Clotting Time in patients presenting with acute bleeding in the operating room

  In the subgroup of patients presenting with either severe or massive hemorrhage as defined previously: correlation between Clotting Time without or with Heparinase (CT / CTH) with Prothrombin Time (PT) and Activated Clotting Time (ACT), all measured in seconds

  From enrollment to 1 month post-operatively

• Correlation of Quantra with fibrinogen concentration in patients presenting with acute bleeding in the operating room

  In the subgroup of patients presenting with either severe or massive hemorrhage as defined previously: correlation between Fibrinogen contribution to Clot Stiffness (FCS), in hPa, and patient's blood fibrinogen concentration in g/L

  From enrollment to 1 month post-operatively

• Correlation of Quantra with platelet count in patients presenting with acute bleeding in the operating room

  In the subgroup of patients presenting with either severe or massive hemorrhage as defined previously: correlation between Platelet contribution to Clot Stiffness (PCS), in hPa, and patient's platelet count in G/L

  From enrollment to 1 month post-operatively

Secondary Outcomes (6)

• Correlation of Quantra with Prothrombin Time (PT) and Activated Clotting Time (ACT) in patients without bleeding

  From enrollment to 1 month post-operatively

• Correlation of Quantra with fibrinogen concentration in patients without bleeding

  From enrollment to 1 month post-operatively

• Correlation of Quantra with platelet count in patients without bleeding

  From enrollment to 1 month post-operatively

• Correlation between Quantra and prothrombin time transfusion threshold in patients presenting with hemorrhage in cardiac surgery

  From enrollment to 1 month post-operatively

• Correlation between Quantra and fibrinogen concentration transfusion thresholds in patients presenting with hemorrhage in cardiac surgery

  From enrollment to 1 month post-operatively

Study Arms (1)

Monocentric consecutive patients undergoing cardiac surgery

Monocentric consecutive patients undergoing cardiac surgery, tested for biological hemostasis during surgery with both viscoelastometric assay (Quantra Qplus) and QT, ACT, fibrinogenemia, platelet count.

Diagnostic Test: Viscoelastometric hemostatic assay

Interventions

Viscoelastometric hemostatic assay DIAGNOSTIC_TEST

As part of usual care, when weaning the patient from CPB during cardiac surgery, blood samples are withdrawn from the patient to assess hemostasis: we test both Quantra viscoelastometric assay and biological hemostasis including QT, ACT, fibrinogen and platelet count

Also known as: Quantra

Monocentric consecutive patients undergoing cardiac surgery

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

Monocentric prospective population of consecutive patients undergoing cardiac surgery with cardiopulmonary bypass

You may qualify if:

• cardiac surgery with cardiopulmonary bypass, either scheduled or urgent
• adult patient
• hemostatic assay including Quantra and standard biology (PT, ACT, fibrinogen concentration and platelet count) at cardiopulmonary bypass weaning (post-protamine)

You may not qualify if:

• \- non-opposition for participation not collected

Sponsors & Collaborators

• Pitié-Salpêtrière Hospital: lead

Study Sites (1)

Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

Related Publications (4)

• Dyke C, Aronson S, Dietrich W, Hofmann A, Karkouti K, Levi M, Murphy GJ, Sellke FW, Shore-Lesserson L, von Heymann C, Ranucci M. Universal definition of perioperative bleeding in adult cardiac surgery. J Thorac Cardiovasc Surg. 2014 May;147(5):1458-1463.e1. doi: 10.1016/j.jtcvs.2013.10.070. Epub 2013 Dec 9.

  PMID: 24332097 BACKGROUND

• Naik BI, Tanaka K, Sudhagoni RG, Viola F. Prediction of hypofibrinogenemia and thrombocytopenia at the point of care with the Quantra(R) QPlus(R) System. Thromb Res. 2021 Jan;197:88-93. doi: 10.1016/j.thromres.2020.11.008. Epub 2020 Nov 10.

  PMID: 33197797 BACKGROUND

• Huffmyer JL, Fernandez LG, Haghighian C, Terkawi AS, Groves DS. Comparison of SEER Sonorheometry With Rotational Thromboelastometry and Laboratory Parameters in Cardiac Surgery. Anesth Analg. 2016 Dec;123(6):1390-1399. doi: 10.1213/ANE.0000000000001507.

  PMID: 27749339 BACKGROUND

• Achneck HE, Sileshi B, Parikh A, Milano CA, Welsby IJ, Lawson JH. Pathophysiology of bleeding and clotting in the cardiac surgery patient: from vascular endothelium to circulatory assist device surface. Circulation. 2010 Nov 16;122(20):2068-77. doi: 10.1161/CIRCULATIONAHA.110.936773. No abstract available.

  PMID: 21098468 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Shock, Hemorrhagic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Adrien Bouglé, Md, PhD

  Pitié-Salpêtrière Hospital

  STUDY DIRECTOR

• Geoffroy Hariri, MD

  Pitié-Salpêtrière Hospital

  STUDY CHAIR

• Pierre Basse, MD

  Pitié-Salpêtrière Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 6, 2025
• Study Start: July 10, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 15, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: From July 2025 to July 2027
• Access Criteria: Contact to principal investigator who will then refer to the study sponsor (Assistance Publique-Hopitaux de Paris, Hôpital de la Pitié-Salpêtrière)

Locations

FR (1)