Salvaged Red Blood Cell Transfusion for Pancreatic Cancer

MD
MD
Overseen ByMadeleine D. Hunter
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of using salvaged red blood cell transfusions during surgery for pancreatic cancer. The goal is to determine the frequency and timing of side effects, such as infections or transfusion reactions, after surgery. Participants will receive either their own salvaged blood or donor blood, depending on the available blood during surgery. This trial may suit individuals with confirmed pancreatic cancer who are preparing for surgery and do not have significant heart problems or active infections. As an unphased trial, it offers an opportunity to contribute to important research that could enhance surgical outcomes for future patients.

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 the Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System is safe for use during pancreatic surgery?

Research shows that the Fresenius Kabi C.A.T.S®plus system, which reuses a patient's own blood during pancreatic surgery, is generally safe. This system collects and returns the patient's blood during the operation, reducing the need for donated blood. Studies on similar systems have found them to be well-tolerated, with few serious side effects.

When reviewing the use of a patient's own blood, researchers confirmed the quality and safety of the blood returned. Few unintended medical problems occurred, and those that did were mild. Common issues might include fever or mild allergic reactions, but serious problems are rare.

The trial includes two groups: one using their own blood and another using donor blood. Both methods are under study for safety, but past evidence supports the safety of using a patient's own blood during surgery. Overall, using one's own blood is considered a safe option.12345

Why are researchers excited about this trial?

Researchers are excited about the use of the Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System for pancreatic cancer surgery because it offers a unique approach to blood transfusion. Unlike standard transfusion practices that rely on donor blood (allogeneic transfusion), this system allows patients to receive their own salvaged blood (autologous transfusion) during surgery. This method minimizes the risk of transfusion-related complications, such as immune reactions and infections, and could potentially improve recovery outcomes. By reducing reliance on donor blood, this approach also addresses blood supply shortages, making it a promising advancement in surgical care for cancer patients.

What evidence suggests that the Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System is effective for pancreatic cancer surgery?

This trial evaluates the effectiveness of the Fresenius Kabi C.A.T.S®plus system in using a patient's own blood during surgery. Participants in the autologous group will have their salvaged blood collected and returned, reducing the need for donor blood. Research has shown that this system maintains good levels of red blood cells and removes unwanted proteins, keeping the blood healthy. Using the patient's own blood lowers the risk of immune reactions or infections associated with donor blood. This method is considered a safe and promising option for patients undergoing pancreatic surgery.12356

Who Is on the Research Team?

MD

Michael D. Kluger, MD, MPH

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults (18+) with confirmed pancreatic cancer who are scheduled for surgery, have a good general health status, and meet certain blood test requirements. Participants must be able to understand the study and give consent.

Inclusion Criteria

Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1-4
Life expectancy of greater than six months
Platelet count greater than 200,000/mm3
See 9 more

Exclusion Criteria

I do not have serious health issues that make surgery too risky for me.
I have a drain or fluid collection near my pancreas seen on imaging.
I have had heart failure or my heart's pumping ability is below 40%.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Peri-operative

Participants undergo pancreatic surgery with sRBC or aRBC transfusion

1 day
1 visit (in-person)

Post-operative Monitoring

Participants are monitored for adverse events and transfusion-related outcomes

7 days
Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System

Trial Overview

The study is testing the safety of using a machine (Fresenius Kabi C.A.T.S®plus) that collects and returns your own blood during pancreatic surgery, comparing it to standard donor blood transfusions.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Autologous group - sRBCExperimental Treatment1 Intervention
Group II: Allogeneic group - aRBCExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Citations

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Salvaged Red Blood Cell Transfusion for Pancreatic Cancer

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Safety of auto-transfusion during pancreatic surgery

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Clinical Utility of Autologous Salvaged Blood: a Review

This review focuses on issues concerning the quality of red blood cells (RBC), efficiency, and the cost effectiveness relative to autotransfusion. The key ...