Acute Normovolemic Hemodilution for Cardiac Surgery
(ANH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a method called acute normovolemic hemodilution (ANH) to reduce the need for blood transfusions during heart surgery. ANH involves removing some of a patient's blood before surgery and returning it afterward, which may improve blood clotting and conserve blood. Patients planning elective heart surgery who can safely have a certain amount of blood withdrawn might be suitable for this study. The goal is to determine if ANH can reduce the number of transfusions by 20%. Success could improve blood management in heart surgeries worldwide. As an unphased trial, this study allows patients to contribute to innovative blood management strategies that could enhance surgical outcomes globally.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that acute normovolemic hemodilution is safe for cardiac surgery patients?
Research has shown that acute normovolemic hemodilution (ANH) is generally safe for patients undergoing heart surgery. In a study with over 1,000 patients, those who underwent ANH experienced similar safety outcomes to those who did not. Specifically, the number of deaths within 30 days or during the hospital stay was very low, at about 1.4% for patients in the ANH group.
Another study examined nearly 17,000 patients, with ANH used in a smaller portion of them. This large group demonstrates that ANH is well-tolerated by most patients.
Overall, these findings suggest that ANH is a safe option for reducing the need for blood transfusions during heart surgery.12345Why are researchers excited about this trial?
Researchers are excited about acute normovolemic hemodilution (ANH) for cardiac surgery because it offers a unique approach to managing blood loss. Unlike standard treatments that often rely on blood transfusions, ANH involves withdrawing and storing a patient's own blood before surgery and then reinfusing it afterward. This method reduces the need for donor blood, minimizing the risk of transfusion-related complications and conserving blood resources. Additionally, by maintaining a patient's blood volume with their own blood, this technique aims to improve overall surgical outcomes and recovery.
What evidence suggests that acute normovolemic hemodilution is effective for reducing RBC transfusions in cardiac surgery?
This trial will compare acute normovolemic hemodilution (ANH) with standard care in cardiac surgery. Research has shown that ANH does not significantly reduce the need for blood transfusions in heart surgery patients. Specifically, studies found that ANH did not decrease the number of patients needing transfusions during or after surgery. Another report confirmed these findings, showing no significant drop in transfusion rates with ANH. Although ANH has been used for many years, current evidence does not support its effectiveness in reducing transfusions in this setting. Therefore, the impact of ANH on saving blood during heart surgery remains uncertain based on existing data.12367
Who Is on the Research Team?
Alberto Zangrillo, Prof
Principal Investigator
Vita-Salute University of Milano
Are You a Good Fit for This Trial?
This trial is for cardiac surgery patients who need a procedure involving cardiopulmonary bypass (CPB). They must be scheduled for elective surgery and have given informed consent to participate. Details on who can't join are not provided.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cardiac surgery with or without acute normovolemic hemodilution (ANH) to assess its effect on reducing RBC transfusions
Follow-up
Participants are monitored for safety and effectiveness after treatment, including bleeding and ischemic complications, AKI, and mortality
What Are the Treatments Tested in This Trial?
Interventions
- Acute normovolemic hemodilution
Find a Clinic Near You
Who Is Running the Clinical Trial?
Università Vita-Salute San Raffaele
Lead Sponsor