Quantra Point-of-Care Hemostasis Monitoring

Bleeding Clinical Trial

— QUANTRA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06328647
• Other study ID #: 24-010
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: The Cleveland Clinic
• Contact: Fabio Rodriguez, MD
• Phone: (216) 444-9950
• Email: rodrigf3[@]ccf.org
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Bleeding
• Blood Coagulation Disorders
• Hemostatic Disorder
• Hemostatic Disorders

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