Personalized Blood Transfusion for Cardiac Surgery
(PerP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two methods for determining when patients recovering from open-heart surgery should receive blood transfusions in the ICU. One method uses a fixed blood count level for all patients, while the other, the Demand-Informed Transfusion Decision Rule, considers individual factors like oxygen levels to tailor transfusion needs. The researchers aim to determine if the personalized approach is as safe as the standard one while reducing blood usage. Adults scheduled for heart surgery and likely to need a transfusion might be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance personalized care in the ICU.
What prior data suggests that this transfusion decision rule is safe for cardiac surgery patients?
In a previous study, researchers found that a restrictive transfusion approach—where blood transfusions occur only when absolutely necessary—is as safe as more liberal strategies for patients undergoing heart surgery. This approach involves administering blood only when specific conditions are met, rather than automatically.
Studies have shown that these restrictive methods are safe for survival rates within 30 days after surgery, indicating no increased risk of complications or death shortly after the procedure. Another review found that these methods, which guide transfusions based on specific signs like oxygen levels, lead to good outcomes for most patients.
Overall, current evidence suggests that personalized rules for blood transfusions in heart surgery are well-tolerated. They help reduce unnecessary blood use without adding risk to patients.12345Why are researchers excited about this trial?
Researchers are excited about the Demand-Informed Transfusion Decision Rule because it offers a personalized approach to blood transfusions during cardiac surgery, potentially improving patient outcomes. Unlike the standard restrictive threshold, which recommends transfusion based solely on hemoglobin levels, this method considers additional physiologic markers, such as oxygen delivery and lactate trends, to make more informed decisions. This personalized strategy allows for more precision, potentially reducing unnecessary transfusions and focusing on the individual needs of each patient. By tailoring transfusion decisions, the trial hopes to enhance recovery and safety for cardiac surgery patients.
What evidence suggests that this personalized transfusion strategy is effective for cardiac surgery recovery?
This trial will compare a personalized approach to blood transfusions with a standard restrictive threshold during heart surgery. Studies have shown that a personalized approach, such as the Demand-Informed Transfusion Decision Rule, can lead to better outcomes. Research indicates that using indicators like oxygen levels and lactate can guide the timing of transfusions. This method has significantly reduced unnecessary blood transfusions, lowering patient risks. Previous findings suggest that these personalized guidelines enhance treatment safety without compromising effectiveness. Evidence supports that administering less blood is as safe as giving more for patient survival after surgery. Overall, tailoring transfusion decisions to individual needs may improve recovery after heart surgery while conserving blood.12346
Are You a Good Fit for This Trial?
This trial is for adults recovering in the ICU after open-heart surgery. It focuses on patients who may need a blood transfusion due to anemia during their recovery from cardiac surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive blood transfusions based on either a standard restrictive threshold or a personalized demand-informed strategy in the cardiac ICU
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of mortality, myocardial infarction, stroke, and renal failure
Extended Follow-up
Long-term monitoring for all-cause mortality and other outcomes to assess the safety of the personalized strategy
What Are the Treatments Tested in This Trial?
Interventions
- Demand-Informed Transfusion Decision Rule
Trial Overview
The study compares two ways of deciding when to give a blood transfusion: one uses a fixed hemoglobin level for everyone, and the other personalizes the decision based on each patient's oxygen levels and other signs. The goal is to see if the personalized method is as safe while using less blood.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Beginning on arrival to the cardiac ICU, an absolute safety floor recommends transfusion when hemoglobin is below 7.0 g/dL regardless of physiology. Between 7.0 and 7.5 g/dL, transfusion decisions are guided by predefined physiologic markers of oxygen balance (e.g., indexed oxygen delivery, venous oxygen saturation, lactate trends): transfusion may be deferred when markers indicate adequate oxygen delivery and is recommended when markers indicate compromised delivery. At or above 7.5 g/dL the rule does not recommend transfusion. The rule is advisory; clinicians may override at any time, and overrides are recorded.
Beginning on arrival to the cardiac ICU after surgery, transfusion of red blood cells is generally recommended when hemoglobin is below 7.5 g/dL, consistent with current institutional practice and major restrictive-threshold trials. Standard surgical, anesthesia, perfusion, monitoring, and postoperative care are provided to all participants.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yan Mia Min
Lead Sponsor
Stanford University
Collaborator
Citations
Can clinical guidelines reduce variation in transfusion practice ...
The primary analysis utilized 35,761 elective cardiac surgeries performed between March 2009 and February 2015 and identified a 24.5% reduction (p < 0.0001) in ...
Transfusion Requirements After Cardiac Surgery
Cardiac surgery is associated with a high rate of allogeneic blood transfusion, varying from 40% to 90% in most reports.
Cardiac Surgical Bleeding, Transfusion, and Quality Metrics
PCCs are effective at reducing transfusions in patients with documented coagulopathies as part of a comprehensive PBM program. •. Where possible, a 4-factor PCC ...
Reducing Need for Blood Transfusion during Heart ...
This new guideline will contribute significantly toward improving clinical outcomes in cardiac surgery patients.
Restrictive transfusion practice in cardiac surgery patients is ...
The meta-analysis, which included >9000 patients, found restrictive transfusion thresholds to be as safe as liberal transfusion thresholds for 30-day mortality, ...
Perioperative Blood Transfusion and Blood Conservation ...
Background: A minority of patients having cardiac procedures (15% to 20%) consume more than 80% of the blood products transfused at operation.
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