Quantra Point-of-Care Hemostasis Monitoring

NCT06328647 | Active Not Recruiting FDA Device

• 1 other identifier: 24-010
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will test the hypothesis that utilization of a blood and blood component transfusion algorithm guided by the POC Quantra QPlus System in patients undergoing complex cardiac surgery will reduce RBC, plasma, cryoprecipitate, and platelet transfusion during surgery and the first 12 postoperative hours, compared to standard of care (central laboratory transfusion monitoring at the primary anesthesia provider's discretion).

Conditions

Bleeding; Hemostatic Disorder

Outcome Measures

Primary Outcomes (1)

• Blood and blood component transfusions

  The total number of blood and blood component transfusions (including RBC, plasma, cryoprecipitate, and platelets) during and after cardiac surgery until 12 hours after ICU arrival.

  12 hours after ICU arrival

Secondary Outcomes (1)

• Bleeding

  During hospitalization, up to 24 hours

Other Outcomes (8)

• PT/aPTT

  1 Hour after surgery end

• INR

  1 hour after surgery end

• Platelet

  1 hour after surgery end

Study Arms (2)

POC Quantra QPlus System

EXPERIMENTAL

Perfusion team or trained (certified for POC testing) research personnel will perform hemostasis testing using the Quantra QPlus POC System, results will be interpreted by the primary anesthesia team that will decide if transfusion of blood components is necessary in the operating room and up to 12 hours after surgery in the cardiac surgery intensive care unit (ICU).

Device: POC Quantra QPlus System

Routine Care

ACTIVE COMPARATOR

The primary anesthesia provider will determine the need for blood and blood component transfusion with or without guidance from central laboratory testing for hemostatic abnormalities in the operating room and up to 12 hours after surgery in the cardiac surgery intensive care unit (ICU).

Other: Routine care

Interventions

POC Quantra QPlus System DEVICE

The POC Quantra QPlus System will be located in the operating room. Samples will be processed by trained (certified for POC testing) personnel and interpreted by the primary anesthesia team. The anesthesia team will perform a baseline hemostatic assessment , approximately 15 min prior to separation from CPB, and again 10-20 min following protamine administration using the Quantra POC hemostasis monitor. If persistent bleeding occurs despite clinical management, coagulation will be rechecked by a repeated Quantra assessment and treated as necessary. A Quantra device will be placed in the ICU for assessment for the first 6 hours following surgery.

POC Quantra QPlus System

Routine care OTHER

Blood and blood component transfusions will be determined by provider preference based on clinical findings. The anesthesia caregiver will perform laboratory testing for coagulation management at his/her discretion. Usual laboratory testing may include assessment of TEG with heparinase, platelet count, fibrinogen concentration at approximately 30-40 min prior to separation from cardiopulmonary bypass. Another set of laboratory tests may be sent post-CPB including TEG, platelet count, fibrinogen concentration, PT/aPTT, INR. Anesthesia caregiver will treat clinical bleeding and coagulopathy at his/her discretion.

Routine Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or more
• Scheduled for aortic surgery or high-risk cardiac surgery requiring cardiopulmonary bypass (high-risk surgery includes reoperative surgery, active endocarditis, expected need for intraoperative circulatory arrest, radiation heart disease, end-stage kidney disease requiring renal replacement therapy, combination surgery including more than one valve or valve plus CABG, low left ventricular ejection fraction \[EF\<30%\] with potential need for mechanical circulatory support with intra-aortic balloon pump, extracorporeal membrane oxygenation \[ECMO\], pulmonary thromboembolectomy or percutaneous left ventricular assist device (VAD), and planned placement of a durable left VAD with or without placement of RV assist device.

You may not qualify if:

• Preoperative diagnosis of a pre-existing coagulation or bleeding disorder
• Preoperative abnormal coagulation disorder (platelet count below 100,000/uL and/or aPTT \>40 seconds in the absence of heparin therapy. Prolonged aPTT \>40 seconds in the acceptable if due to heparin therapy.)
• Liver disease, defined as a history of cirrhosis, liver enzymes \>3x normal range or manifested by elevated PT suggesting abnormal liver synthetic function not explained by other comorbidities
• Pregnancy or breastfeeding
• Refusal to accept red blood cells and blood component transfusions.
• Contraindications to proposed interventions.
• Unable to understand English as a first language or unable comprehend the study and/or the consent forms.
• Vulnerable patients including prisoners, human fetuses, and neonates

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hemorrhage; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Andra Duncan, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and outcome assessor will be masked to the group allocation. Clinicians will be unmasked to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 25, 2024
• Study Start: October 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)