RECRUITING

Quantra Point-of-Care Hemostasis Monitoring

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-10-03

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06328647

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adults aged 18 years or more 2. 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 \[ECMO\], or percutaneous left ventricular assist device)	1. Preoperative diagnosis of a pre-existing coagulation or bleeding disorder 2. Preoperative abnormal coagulation disorder (aPTT\>40 seconds in the absence of heparin therapy and/or platelet count below 100,000/uL) 3. 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 4. Pregnancy or breastfeeding 5. Refusal to accept red blood cells and blood component transfusions. 6. Contraindications to proposed interventions. 7. Unable to understand English as a first language or unable comprehend the study and/or the consent forms. 8. Vulnerable patients including prisoners, human fetuses, and neonates

Inclusion Criteria

Exclusion Criteria

1. Adults aged 18 years or more
2. 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 \[ECMO\], or percutaneous left ventricular assist device)

1. Preoperative diagnosis of a pre-existing coagulation or bleeding disorder
2. Preoperative abnormal coagulation disorder (aPTT\>40 seconds in the absence of heparin therapy and/or platelet count below 100,000/uL)
3. 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
4. Pregnancy or breastfeeding
5. Refusal to accept red blood cells and blood component transfusions.
6. Contraindications to proposed interventions.
7. Unable to understand English as a first language or unable comprehend the study and/or the consent forms.
8. Vulnerable patients including prisoners, human fetuses, and neonates

Contacts and Locations

Study Contact

Fabio Rodriguez, MD

CONTACT

(216) 444-9950

rodrigf3@ccf.org

Andra Duncan, MD

CONTACT

216 445-2372

duncana@ccf.org

Principal Investigator

Andra Duncan

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Andra Duncan, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-03

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-10-03

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Bleeding
Hemostatic Disorder