ANH for Cardiac Surgery

(ANH Trial)

Overseen By Jennifer Scovotti, MA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of California, Los Angeles

Disqualifiers: Anemia, Heart failure, Liver disease, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

63 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if using a patient's own blood during complex heart surgery can reduce the need for donor blood. It aims to see if this method can improve outcomes by minimizing transfusion risks.

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 (ANH) for cardiac surgery?

Research suggests that ANH may help reduce bleeding and the need for blood transfusions in high-risk cardiac surgeries, although its effectiveness is still debated. Some studies indicate it is safe in other surgeries, like neurosurgery, but its benefits in cardiac surgery remain uncertain. ^{1 2 3 4 5}

Is acute normovolemic hemodilution (ANH) safe for humans?

Research indicates that acute normovolemic hemodilution (ANH) is generally safe for humans, including in neurosurgery and cardiac surgery, although there are concerns about potential hemodynamic instability (changes in blood flow) and organ injury during the procedure. ^{1 2 3 4 6}

How is the treatment ANH different from other treatments for cardiac surgery?

Acute normovolemic hemodilution (ANH) is unique because it involves removing some of the patient's blood before surgery and replacing it with a fluid that doesn't contain cells, which helps conserve the patient's own blood during surgery. This method aims to reduce the need for blood transfusions from donors, but its effectiveness and safety in complex cardiac surgeries are still debated. ^{4 5 7 8 9}

Research Team

Lorraine Lubin, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for adult patients who need complex cardiac surgery, like redo surgeries or aortic surgery requiring deep hypothermic circulatory arrest. It's not for those with low-risk heart conditions, anemia, recent heart attacks, severe aortic stenosis with reduced heart function, pulmonary hypertension, significant liver disease, clotting disorders or advanced kidney disease.

Inclusion Criteria

Adult patients presenting for elective cardiac surgery

You have had surgery on your heart or aorta that involved redo surgery, adult congenital heart disease, or deep hypothermic circulatory arrest.

Exclusion Criteria

Patient refusal to participate in the study

You have a low-risk heart surgery.

You have had heart surgery that did not require the use of a heart-lung machine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intraoperative

Patients undergo complex cardiac surgery with or without acute normovolemic hemodilution (ANH)

During surgery

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for cardiovascular support and transfusion requirements

72 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after surgery

5-10 days

Treatment Details

Interventions

• Acute normovolemic hemodilution (ANH)

Trial Overview The study tests acute normovolemic hemodilution (ANH), which involves removing some blood from the patient before surgery to reduce the need for transfusions. The focus is on its benefits and safety in complex cardiac surgeries that typically require more blood products.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Perform blood conservation in the operating room (OR).

Group II: Control Group Active Control 1 Intervention

Blood conservation will not be performed in the OR.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

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]

Acute Normovolemic Hemodilution (ANH) significantly reduced the need for homologous blood transfusions in children undergoing posterior spinal fusion, with only 28% of the ANH group requiring transfusions compared to 79% in the control group.

The study found that ANH was safe, with no anemia-related complications reported, and it did not increase the risk of postoperative complications compared to the control group, suggesting it is an effective method for managing blood loss in pediatric surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute normovolemic hemodilution in children submitted to posterior spinal fusion. de Oliveira, GS., Tenório, SB., Cumino, DO., et al.[2014]

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 is safe in neurosurgery. [2016]

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

Hemodilution in high-risk cardiac surgery: Laboratory values, physiological parameters, and outcomes. [2022]

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

Absence of beneficial effect of acute normovolemic hemodilution combined with aprotinin on allogeneic blood transfusion requirements in cardiac surgery. [2019]

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

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

7. Lebanon pubmed.ncbi.nlm.nih.gov

Intraoperative minimal acute normovolemic hemodilution in patients undergoing coronary artery bypass surgery. [2014]

8. England pubmed.ncbi.nlm.nih.gov

Acute Normovolemic Hemodilution in Surgery. [2016]

9. Brazil pubmed.ncbi.nlm.nih.gov

Acute normovolemic hemodilution in children submitted to posterior spinal fusion. [2014]