Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Blood Conservation in Cardiac Surgery Using a Novel Transfusion Algorithm Based on Point-of-care Testing-A Stepped-wedge Cluster Randomized Controlled Trial
Brief Summary: This multi-centre study will provide sound, generalizable data on the effectiveness of a POC-based algorithm to determine to what extent this guideline can reduce blood product transfusions. Investigators will study outcomes in 7000 patients undergoing heart surgery at 10 participating hospitals. The proposed trial addresses several important research and clinical issues and has the potential to markedly improve the transfusion management and surgical care in general of cardiac surgery patients.

The intervention will be a novel POC-based algorithm that has been shown in a pilot study by us to be associated with a substantial reduction in blood product transfusions. The algorithm will employ viscoelastic and aggregometric POC-tests and an objective measure of blood loss. The primary outcome will be avoidance of red blood cell transfusion during hospitalization. The study has a 90% power to detect a 12% increase in avoidance rate. Secondary outcomes will include avoidance of red blood cell use and other blood products (plasma, platelets, and cryoprecipitate), units of blood products transfused, and adverse clinical outcomes related to transfusion (acute kidney injury, infections, and death). Data will also be collected for future health-economics analyses.

Largely due to the limitations of existing evidence, however, such algorithms are rarely used in clinical practice. The proposed trial will provide sound, generalizable data on the effectiveness of a POC-based algorithm to guide their future use. An integrated blood management algorithm that employs POC coagulation tests will reduce blood product transfusions in cardiac surgery, thereby improving clinical outcomes.

Does an integrated blood transfusion algorithm that employs POC coagulation tests applied across a network of hospitals reduce blood transfusions and associated adverse outcomes in cardiac surgery?


Options:
A: Arm Label: Group A: RiaSTAP; Type: EXPERIMENTAL; Interventions: Drug: Human fibrinogen concentrate | Arm Label: Group B: apheresis platelets; Type: ACTIVE_COMPARATOR; Interventions: Other: apheresis platelets | Intervention Type: DRUG; Name: Human fibrinogen concentrate; Assigned to Arm(s): Group A: RiaSTAP | Intervention Type: OTHER; Name: apheresis platelets; Assigned to Arm(s): Group B: apheresis platelets
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Active; Type: ACTIVE_COMPARATOR; Interventions: Drug: Eltrombopag | Intervention Type: DRUG; Name: Eltrombopag; Assigned to Arm(s): Active | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Transfusion Algorithm; Type: OTHER; Interventions: Other: POC-based transfusion algorithm | Intervention Type: OTHER; Name: POC-based transfusion algorithm; Assigned to Arm(s): Transfusion Algorithm
D: Arm Label: 1:1:1 Blood Transfusion Ratio; Type: ACTIVE_COMPARATOR; Interventions: Biological: 1:1:1 Blood Transfusion Ratio | Arm Label: 1:1:2 Blood Transfusion Ratio; Type: ACTIVE_COMPARATOR; Interventions: Biological: 1:1:2 Blood Transfusion Ratio | Intervention Type: BIOLOGICAL; Name: 1:1:1 Blood Transfusion Ratio; Assigned to Arm(s): 1:1:1 Blood Transfusion Ratio | Intervention Type: BIOLOGICAL; Name: 1:1:2 Blood Transfusion Ratio; Assigned to Arm(s): 1:1:2 Blood Transfusion Ratio

Answer: C