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NCT Number: NCT06328647

Quantra Point-of-Care Hemostasis Monitoring

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Bleeding Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorder Hemostatic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

The Investigators propose a randomized control trial to assess patients scheduled for aortic surgery or high-risk cardiac surgery requiring cardiopulmonary bypass.

Patients will be randomized 1:1 to routine care or POC Quantra QPlus System. 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 will be analyzed between the groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Blood and blood component transfusions

    Time frame: 12 hours after ICU arrival

    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.

Secondary outcomes

  1. Bleeding

    Time frame: During hospitalization, up to 24 hours

    Postoperative bleeding assessed by the Universal Definition of perioperative bleeding during index hospitalization, which classification into categories 0 - 4 based upon the following complications related to perioperative bleeding: the assessment of delayed sternal closure; amount of postoperative chest tube blood loss within 12 hours; Units of PRBC, FFP, platelets, and cryoprecipitate; need for PCCs or rFVIIa, or re-exploration/tamponade.

Other outcomes

  1. PT/aPTT

    Time frame: 1 Hour after surgery end

    Postoperative PT/aPTT measurement at 1 hour (±1 hr) after surgery end.

  2. INR

    Time frame: 1 hour after surgery end

    Postoperative INR measurement at 1 hour (±1 hr) after surgery end.

  3. Platelet

    Time frame: 1 hour after surgery end

    Postoperative platelet count measurement at 1 hour (±1 hr) after surgery end.

  4. Fibrinogen

    Time frame: 1 hour after surgery end

    Postoperative fibrinogen measurement at 1 hour (±1 hr) after surgery end.

  5. hematocrit/hemoglobin

    Time frame: 1 hour after surgery end

    Postoperative hematocrit/hemoglobin measured at 1 hour (±1 hr) after surgery end.

  6. ICU length of stay

    Time frame: During hospitalization, an average of 30 days.

    ICU length of stay

  7. Hospital length of stay.

    Time frame: During hospitalization, an average of 30 days.

    Hospital length of stay.

  8. In-hospital mortality

    Time frame: During hospitalization

    In-hospital mortality

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Quantra Point-of-Care Hemostasis Monitoring and Perioperative Blood and Blood Component Transfusion During High-Risk Complex Cardiac Surgery: A Randomized Clinical Trial

Acronym: QUANTRA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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