Quantra Point-of-Care Hemostasis Monitoring

NARecruitingINTERVENTIONAL
Enrollment

666

Participants

Timeline

Start Date

October 3, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
BleedingHemostatic Disorder
Interventions
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.

Trial Locations (1)

44195

RECRUITING

Cleveland Clinic Foundation, Cleveland

All Listed Sponsors
lead

The Cleveland Clinic

OTHER