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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PT/aPTT | Postoperative PT/aPTT measurement at 1 hour (±1 hr) after surgery end. | 1 Hour after surgery end |
| INR | Postoperative INR measurement at 1 hour (±1 hr) after surgery end. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andra Duncan, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Randomized Clinical Trial
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Patients and outcome assessor will be masked to the group allocation. Clinicians will be unmasked to group allocation.
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| 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. |
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| During hospitalization, up to 24 hours |
| 1 hour after surgery end |
| Platelet | Postoperative platelet count measurement at 1 hour (±1 hr) after surgery end. | 1 hour after surgery end |
| Fibrinogen | Postoperative fibrinogen measurement at 1 hour (±1 hr) after surgery end. | 1 hour after surgery end |
| hematocrit/hemoglobin | Postoperative hematocrit/hemoglobin measured at 1 hour (±1 hr) after surgery end. | 1 hour after surgery end |
| ICU length of stay | ICU length of stay | During hospitalization, an average of 30 days. |
| Hospital length of stay. | Hospital length of stay. | During hospitalization, an average of 30 days. |
| In-hospital mortality | In-hospital mortality | During hospitalization |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |