What side effects are associated with this type of intervention?

Common treatments for heart conditions, particularly those involving blood transfusion strategies, include red blood cell transfusions and iron replacement therapy. Known side effects of red blood cell transfusions can include allergic reactions, fever, iron overload, and in rare cases, transfusion-related acute lung injury (TRALI). Iron replacement therapy, especially intravenous iron, can cause side effects such as allergic reactions, hypotension, and gastrointestinal disturbances. It is important to weigh the benefits and risks of these treatments in consultation with a healthcare provider.

What prior FDA approvals exist?

FDA approvals for heart-related treatments have included various drugs and therapies aimed at improving outcomes in cardiac surgery patients. Notable approvals include statins like atorvastatin and rosuvastatin, which have been shown to reduce postoperative atrial fibrillation, as seen in the ARMYDA-3 and other studies. Additionally, anticoagulants such as warfarin and novel oral anticoagulants (NOACs) have been approved for managing postoperative atrial fibrillation to prevent thromboembolic events. Beta-blockers like metoprolol and carvedilol are also commonly used to manage heart rate and rhythm post-surgery. These treatments align with the goals of the TRICS-IV trial, which compares different blood transfusion protocols to optimize patient outcomes in cardiac surgery.

What other types of research exist?

Promising novel alternatives to traditional transfusion strategies for heart patients include the development of blood substitutes or oxygen therapeutics. These agents are designed to deliver oxygen to ischemic tissues effectively, potentially reducing the reliance on donor blood. Additionally, ongoing research such as the TRICS-IV trial, which compares different transfusion protocols, aims to identify the most effective strategies for improving patient outcomes in cardiac surgery.

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Transfusion Strategies for Cardiac Surgery Patients (TRICS-IV Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for heart conditions, particularly in the context of cardiac surgery and heart failure, include blood transfusions, iron replacement, vasodilators, and mechanical circulatory support. Blood transfusions aim to improve oxygen delivery to tissues by increasing hemoglobin levels, which is crucial during and after cardiac surgery. Iron replacement helps manage iron deficiency, reducing hospital admissions and potentially improving outcomes in heart failure patients. Vasodilators reduce cardiac workload by dilating blood vessels, improving blood flow, and reducing the heart's effort to pump blood. Mechanical circulatory support devices assist or replace the heart's pumping function in severe cases, ensuring adequate blood circulation. These treatments are vital for optimizing patient outcomes, reducing complications, and improving overall heart function.

N/A

Recruiting

Led By David Mazer, MD

Research Sponsored by Unity Health Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to hospital discharge or after 28 days postoperatively, whichever comes first.

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying different methods to help patients recover better after heart surgery.

Who is the study for?

This trial is for younger patients (18-65 years old) with a moderate to high risk of complications from cardiac surgery, as indicated by a EuroSCORE I of 6 or more. They must be undergoing heart surgery that requires cardiopulmonary bypass and able to give informed consent. It's not for those who refuse blood products, are in certain pre-surgery donation programs, need a heart transplant or ventricular assist device alone, or women who are pregnant or breastfeeding.

What is being tested?

The TRICS-IV study compares two blood transfusion strategies during cardiac surgery: 'Restrictive' gives fewer transfusions based on specific criteria while 'Liberal' provides them more freely. Patients will be randomly assigned to one of these approaches to see which is superior for those under 65 at higher surgical risk.

What are the potential side effects?

Potential side effects may include reactions related to blood transfusions such as fever, allergic responses, lung injury, and in rare cases infections or immune system effects. The risks vary depending on the strategy used and individual patient factors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to hospital discharge or after 28 days postoperatively, whichever comes first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to hospital discharge or after 28 days postoperatively, whichever comes first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to hospital discharge or after 28 days postoperatively, whichever comes first. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite score of any one of the following events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke).

Secondary study objectives

Acute kidney injury.

Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

Delirium.

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Restrictive Transfusion StrategyActive Control1 Intervention

Patients will receive a RBC transfusion if their Hb concentration is \<75 g/L (\<7.5 g/dL; \<4.7mmol/L) intraoperatively and/or postoperatively.

Group II: Liberal Transfusion StrategyActive Control1 Intervention

Patients will receive a RBC transfusion if their Hb concentration is \<95 g/L (\<9.5 g/dL; \<5.9mmol/L) intraoperatively, or postoperatively in the ICU; and/or \<85 g/L (\< 8.5 g/dL; \<5.3mmol/L) on the ward.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart conditions, particularly in the context of cardiac surgery and heart failure, include blood transfusions, iron replacement, vasodilators, and mechanical circulatory support. Blood transfusions aim to improve oxygen delivery to tissues by increasing hemoglobin levels, which is crucial during and after cardiac surgery. Iron replacement helps manage iron deficiency, reducing hospital admissions and potentially improving outcomes in heart failure patients. Vasodilators reduce cardiac workload by dilating blood vessels, improving blood flow, and reducing the heart's effort to pump blood. Mechanical circulatory support devices assist or replace the heart's pumping function in severe cases, ensuring adequate blood circulation. These treatments are vital for optimizing patient outcomes, reducing complications, and improving overall heart function.

Management of cardiogenic shock.Interventions related to cardiovascular complications in people hospitalized by covid-19: a scoping review.Effectiveness of revascularization interventions compared with medical therapy in patients with ischemic cardiomyopathy: A systematic review protocol.