Salvaged Red Blood Cell Transfusion for Pancreatic Cancer
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Peri-operative
Participants undergo pancreatic surgery with sRBC or aRBC transfusion
Post-operative Monitoring
Participants are monitored for adverse events and transfusion-related outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Patients with enough salvaged blood to generate a unit for transfusion will be transfused their own (autologous) blood, as long as they were not transfused allogeneic red blood cell (aRBC) during the same operation
Patients requiring transfusion at the discretion of the surgeon and the anesthesiologist without enough salvaged blood to generate a unit for transfusion will be transfused aRBC.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor
Citations
Salvaged Red Blood Cell Transfusion During Pancreatic ...
It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo ...
Salvaged Red Blood Cell Transfusion for Pancreatic Cancer
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 ...
Transfusion of salvaged red blood cells during pancreatic ...
This experimental study aimed to compare the frequency of CTCs from pancreatic ductal adenocarcinoma (PDAC) in systemic preoperative, systemic intraoperative, ...
In Vitro Evaluation of the Fresenius Kabi CATSmart ... - PMC
The CATSmart and C.A.T.Splus systems both provided a high-quality product in terms of HCT, protein elimination, and hemolysis rates across the range of tested ...
5.
columbiasurgery.org
columbiasurgery.org/clinical-trials/safety-auto-transfusion-during-pancreatic-surgerySafety of auto-transfusion during pancreatic surgery
A pilot study to determine the safety of recovered blood intended for auto- transfusion during pancreatic cancer operations. Prospective protocol assessing ...
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 ...
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