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Procedure

Acute Normovolemic Hemodilution (ANH) Arm for Peritoneal Neoplasm

Phase 2

Recruiting

Led By Dennis Chi, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

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 up to 30 days from procedure

Awards & highlights

Study Summary

This trial will assign participants undergoing primary cytoreductive surgery to receive either acute normovolemic hemodilution (ANH) or standard surgical management. The researchers believe that ANH may reduce

Who is the study for?

This trial is for individuals with ovarian cancer or related conditions who are scheduled for primary cytoreductive surgery. Specific eligibility details aren't provided, but typically participants must meet certain health criteria to ensure safety and the ability to follow the study's procedures.Check my eligibility

What is being tested?

The trial is testing acute normovolemic hemodilution (ANH) during surgery against standard surgical management. Participants will be randomly assigned to one of these two approaches to see if ANH can reduce the need for blood transfusions during surgery.See study design

What are the potential side effects?

Potential side effects of ANH may include changes in blood pressure, altered heart rate, imbalances in blood components, or reactions at the site where blood is drawn or returned. The exact side effects will depend on individual responses and procedure outcomes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days from procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days from procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days from procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Acute Normovolemic Hemodilution (ANH) ArmExperimental Treatment1 Intervention

Group II: Standard Intraoperative Management ArmActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,812 Total Patients Enrolled

Dennis Chi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

6 Previous Clinical Trials

377 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its approval for the Acute Normovolemic Hemodilution (ANH) Arm?

"In this Phase 2 trial, the safety rating for the Acute Normovolemic Hemodilution (ANH) Arm is determined to be a 2 by our team at Power. This indicates that while there is existing safety data, no evidence currently supports its efficacy."

Answered by AI

What is the current number of individuals involved in this research endeavor?

"Indeed, according to clinicaltrials.gov, this investigation is actively seeking volunteers. It was first registered on February 23rd, 2024 and last revised on February 26th, 2024. The objective is to recruit a total of 86 participants from seven distinct sites."

Answered by AI

Is the enrollment for this investigation presently open?

"As per the information available on clinicaltrials.gov, patient recruitment is ongoing for this particular trial. The trial was initially listed on 2/23/2024 and last modified on 2/26/2024."

Answered by AI

How widespread is the participation of medical facilities in Canada for this trial?

"At present, patient recruitment is ongoing at 7 distinct sites. These include facilities in Basking Ridge, Middletown, Montvale, and several other locations. Opting for the nearest site can help mitigate travel-related inconveniences once you are enrolled."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Primary Cytoreductive Surgery

2024. "Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Primary Cytoreductive Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06290193.

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