Acute Normovolemic Hemodilution for Cardiac Surgery

(ANH Trial)

Not currently recruiting at 42 trial locations

Overseen By Giovanni Landoni, Prof

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Università Vita-Salute San Raffaele

Disqualifiers: Unstable coronary artery disease, Pregnancy, Emergency surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: During hospital stay, an average of 10 days

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 Patients planning elective heart surgery who can safely have a certain amount of blood withdrawn might be suitable for this study.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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 6 7}

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

Signed informed consent

I am planning to have surgery that is not an emergency.

I have had heart surgery with a heart-lung machine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac surgery with or without acute normovolemic hemodilution (ANH) to assess its effect on reducing RBC transfusions

During hospital stay, an average of 10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including bleeding and ischemic complications, AKI, and mortality

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Acute normovolemic hemodilution

Trial Overview The study is testing acute normovolemic hemodilution (ANH) against standard care in cardiac surgeries. It aims to see if ANH reduces the need for red blood cell transfusions during hospital stays, with 2000 patients randomized to ensure reliable results.

How Is the Trial Designed?

Group I: Standard care Experimental Treatment 1 Intervention

No ANH

Group II: ANH Experimental Treatment 1 Intervention

Best available treatments plus ANH, performed withdrawing a volume of blood before the CPB. The volume will be personalized for every patient, but it'll be at least 650ml.

Who Is Running the Clinical Trial?

Università Vita-Salute San Raffaele

Lead Sponsor

Trials

91

Recruited

68,800+

Published Research Related to This Trial

A systematic review of 42 trials found that acute normovolemic hemodilution (ANH) does not significantly reduce the risk of allogeneic blood transfusions compared to usual care or other blood conservation methods, indicating limited efficacy.

While ANH resulted in less total bleeding compared to usual care, it also led to increased intraoperative bleeding, and the overall safety of the procedure remains uncertain, suggesting that its widespread use is not recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative acute normovolemic hemodilution: a meta-analysis. Segal, JB., Blasco-Colmenares, E., Norris, EJ., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40900582/

Acute Normovolemic Hemodilution in Adult Cardiac Surgery Main outcome and measures: The primary outcome was intraoperative or postoperative transfusion of any blood component. The volume-dependent ANH ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2504948

A Randomized Trial of Acute Normovolemic Hemodilution ... Among adults undergoing cardiac surgery, ANH did not reduce the number of patients receiving allogeneic red-cell transfusion.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424001885

Acute normovolemic hemodilution in cardiac surgery The trial is designed to determine whether ANH can safely reduce RBC transfusion after elective cardiac surgery with CPB.

4. jcvaonline.com jcvaonline.com/article/S1053-0770(25)00637-8/fulltext

Acute Normovolemic Hemodilution in Cardiac Surgery The results were unequivocal: ANH did not significantly reduce the proportion of patients receiving at least one RBC transfusion. Despite the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03913481

Acute Normovolemic Hemodilution in High Risk Cardiac ... We designed a multicenter randomized controlled trial to investigate the effect of ANH in reducing the number of cardiac surgery patients receiving RBC ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40503713/

A Randomized Trial of Acute Normovolemic Hemodilution ... Safety outcomes were similar in the two groups. Conclusions: Among adults undergoing cardiac surgery, ANH did not reduce the number of ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03913481

Acute Normovolemic Hemodilution in High Risk Cardiac ... We designed a multicenter randomized controlled trial to investigate the effect of ANH in reducing the number of cardiac surgery patients receiving RBC ...