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Procedure
ANH for Cardiac Surgery (ANH Trial)
Phase 3
Recruiting
Led By Lorraine Lubin, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of 5-10 days until discharge from the hospital, whichever came first
Awards & highlights
ANH Trial Summary
This trial will study whether Acute normovolemic hemodilution (ANH), a blood conservation technique, can reduce transfusion in complex cardiac surgery patients. ANH has been demonstrated to reduce transfusion in lower risk cardiac surgery without any significant complications.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
ANH has minimal risk but potential side effects may include complications related to lower blood volume during surgery such as dizziness or fainting. There's also a small chance of affecting organ function if too much blood is removed.
ANH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Packed red blood cells (pRBC)
Secondary outcome measures
24 Hour Activated Partial Thromboplastin time (aPTT)
24 Hour Chest Tube Output
24 Hour Fibrinogen
+41 moreANH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Perform blood conservation in the operating room (OR).
Group II: Control GroupActive Control1 Intervention
Blood conservation will not be performed in the OR.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acute normovolemic hemodilution (ANH)
2016
N/A
~160
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,739 Total Patients Enrolled
Lorraine Lubin, MDPrincipal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a low-risk heart surgery.You have had heart surgery that did not require the use of a heart-lung machine.You have low levels of red blood cells (Hgb) at the start of the study.Your blood's hematocrit level is too low, which could increase the risk of kidney injury during a certain procedure.You have severe blockages in important heart arteries or have recently experienced serious chest pain or a heart attack.You have a severe narrowing of the aortic valve and reduced heart pumping function.You have high blood pressure in the arteries of your lungs.You have a significant liver disease that affects how your blood clots.You have a condition that affects how your blood clots, such as low platelet count or other blood disorders.You have moderate to severe kidney disease or end-stage kidney disease, with or without needing dialysis.You have been on a heart and lung machine before surgery, or the doctors think you might need to be on it after surgery.You have had surgery on your heart or aorta that involved redo surgery, adult congenital heart disease, or deep hypothermic circulatory arrest.You are receiving treatment for low red blood cell count before the surgery.Your heart is not pumping well and you have a condition called decompensated heart failure.You have a heart condition called hypertrophic obstructive cardiomyopathy with significant blockage in the left ventricle.You have had a blood transfusion recently.You have recently had bleeding in your stomach or intestines.You have unstable blood pressure or have recently had a serious infection.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the rate of adverse events for Acute normovolemic hemodilution (ANH)?
"Acute normovolemic hemodilution (ANH) has received a score of 3 from our team at Power. This is because ANH is currently in Phase 3 trials, meaning that there is some data to support efficacy as well as multiple rounds of safety data."
Answered by AI
Can participants sign up for this research right now?
"Yes, this trial is still actively recruiting patients according to the information provided on clinicaltrials.gov. This page was first created on February 28th, 2022 and edited most recently on March 10th, of the same year. The study needs a total of 112 participants from 1 site."
Answered by AI
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