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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06328647
Other study ID # 24-010
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date December 31, 2026

Study information

Verified date June 2024
Source The Cleveland Clinic
Contact Fabio Rodriguez, MD
Phone (216) 444-9950
Email rodrigf3@ccf.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 666
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion 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) Exclusion Criteria: 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

Study Design


Intervention

Device:
POC Quantra QPlus System
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.
Other:
Routine care
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Outcome

Type Measure Description Time frame Safety issue
Other PT/aPTT Postoperative PT/aPTT measurement at 1 hour (±1 hr) after surgery end. 1 Hour after surgery end
Other INR Postoperative INR measurement at 1 hour (±1 hr) after surgery end. 1 hour after surgery end
Other Platelet Postoperative platelet count measurement at 1 hour (±1 hr) after surgery end. 1 hour after surgery end
Other Fibrinogen Postoperative fibrinogen measurement at 1 hour (±1 hr) after surgery end. 1 hour after surgery end
Other hematocrit/hemoglobin Postoperative hematocrit/hemoglobin measured at 1 hour (±1 hr) after surgery end. 1 hour after surgery end
Other ICU length of stay ICU length of stay During hospitalization, an average of 30 days.
Other Hospital length of stay. Hospital length of stay. During hospitalization, an average of 30 days.
Other In-hospital mortality In-hospital mortality During hospitalization
Primary 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 Bleeding 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. During hospitalization, up to 24 hours
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