Acute Normovolemic Hemodilution for Cardiac Surgery

(ANH Trial)

Recruiting at 34 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

2000 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Acute normovolemic hemodilution for cardiac surgery?

Research shows that acute normovolemic hemodilution (ANH) can reduce the need for blood transfusions during cardiac surgery, which is beneficial because it lowers the risk of complications from receiving donor blood. Studies, including systematic reviews and meta-analyses, have found that ANH helps decrease the number of blood transfusions needed in surgeries with high bleeding risk. ^{1 2 3 4 5}

Is acute normovolemic hemodilution safe for humans?

Research indicates that acute normovolemic hemodilution (ANH) is generally safe for use in humans, including in neurosurgery and cardiac surgery, as it helps manage blood loss during operations. ^{1 6 7 8 9}

How does the treatment Acute Normovolemic Hemodilution differ from other treatments for cardiac surgery?

Acute Normovolemic Hemodilution (ANH) is unique because it involves withdrawing a patient's own blood before surgery and replacing it with fluids to maintain blood volume, which reduces the need for donor blood transfusions during cardiac surgery. This method helps preserve the patient's own blood cells and plasma components, ensuring optimal oxygen supply to tissues even with lower blood cell concentrations. ^{1 6 7 10 11}

What is the purpose of this trial?

Transfusions are one of the most overused treatments in modern medicine, and saving blood is one important issue all around the world. Cardiac surgery makes up a large percentage of the overall blood components consumption in surgery. Acute normovolemic hemo-dilution (ANH) is a well-known strategy which has been used for years without the support of high quality evidence based medicine to improve post-cardiopulmonary bypass coagulation and reduce red blood cells (RBC) transfusion. We designed a multicenter randomized controlled trial to investigate the effect of ANH in reducing the number of cardiac surgery patients receiving RBC transfusions during hospital stay. We will randomize 2000 patients to have sufficient power to demonstrate a 20% relative and 7% absolute risk reduction in the number of patients' RBC transfusion. If the results of the study will confirm our hypothesis, this will have a great impact on blood management in cardiac operating room.

Research Team

Alberto Zangrillo, Prof

Principal Investigator

Vita-Salute University of Milano

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Standards and Best Practice for Acute Normovolemic Hemodilution: Evidence-based Consensus Recommendations. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Intraoperative low-volume acute normovolemic hemodilution in adult open-heart surgery. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Acute Normovolemic Hemodilution Reduces Allogeneic Red Blood Cell Transfusion in Cardiac Surgery: A Systematic Review and Meta-analysis of Randomized Trials. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Large volume acute normovolemic hemodilution in patients undergoing cardiac surgery with intermediate-high risk of transfusion: A randomized controlled trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of acute normovolemic hemodilution on coronary artery bypass grafting: A systematic review and meta-analysis of 22 randomized trials. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Preoperative acute normovolemic hemodilution: a meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Acute normovolemic hemodilution. [2011]

8. Japan pubmed.ncbi.nlm.nih.gov

Beneficial effect of acute normovolemic hemodilution in cardiovascular surgery. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Acute normovolemic hemodilution is safe in neurosurgery. [2016]

10. Germany pubmed.ncbi.nlm.nih.gov

[Clinical aspects of hemodilution (author's transl)]. [2007]

11. Germany pubmed.ncbi.nlm.nih.gov

[Avoidance of blood transfusion by acute normovolemic hemodilution (author's transl)]. [2006]