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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to reduce blood transfusions during complex heart surgeries. It tests acute normovolemic hemodilution (ANH), a technique where some of a patient's blood is removed and returned during surgery, to determine if it lowers the need for donated blood. This could be particularly beneficial, as heart surgeries often require significant blood, and transfusions can carry risks. Suitable participants include adults undergoing elective heart surgeries, such as redo surgeries, surgeries for adult congenital heart disease, or aortic surgeries. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking treatment.

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 this technique is safe for complex cardiac surgery?

Research has shown that acute normovolemic hemodilution (ANH) is generally safe for patients undergoing heart surgery. One study found that the death rate was similar for those who had ANH and those who did not, with 1.4% of ANH patients passing away within 30 days or during their hospital stay. Another study examined nearly 17,000 patients and found that ANH was used in about 15% of cases without major complications. These findings suggest that ANH is well-tolerated and does not increase the risk of serious issues during or after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard blood management techniques used during cardiac surgery, such as transfusions of donor blood, acute normovolemic hemodilution (ANH) aims to conserve a patient's own blood. Researchers are excited about ANH because it involves collecting and storing a portion of the patient's blood before surgery and then reinfusing it, which can reduce the need for donor blood and lower the risk of transfusion-related complications. This method not only preserves the patient's own blood cells but also minimizes exposure to potential infections and immune reactions associated with donor blood.

What evidence suggests that ANH is effective for reducing transfusions in complex cardiac surgery?

Research shows that acute normovolemic hemodilution (ANH) saves blood during heart surgeries. This technique involves removing some blood before surgery and returning it afterward, reducing the need for transfusions. In this trial, participants in the intervention group will undergo ANH during their surgery. In simpler heart surgeries, ANH has lowered the need for transfusions without causing major problems. However, studies have shown mixed results for its effectiveness in more complex surgeries. Some research suggests that ANH might not significantly reduce the number of patients needing transfusions. Still, it is considered safe and poses minimal risk to patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Lorraine Lubin, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 ...