Salvaged Red Blood Cell Transfusion During Pancreatic Adenocarcinoma Operations

The purpose of this study is to prospectively study the safety of salvage red blood cell (sRBC) transfusion during pancreatic surgery.

Primary Objective:

1. To summarize rates and timing of septic adverse events (AE) for patients who receive sRBC or aRBC transfusions within 72 hours of peri-operative transfusion.
2. To summarize rates and timing of transfusion related AEs for patients who receive sRBC or aRBC transfusions within 72 hours of peri-operative transfusion.
3. To summarize rates and timing of AEs in the first 7 post-operative days.

Secondary Objectives:

1. To summarize the number of units of aRBC transfused post operative day (POD) #0 after sRBC transfusion in the operating room.
2. To summarize the number of units of aRBC transfused POD#1-7 after sRBC transfusion the operating room, in the absence of overt post-operative hemorrhage.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Surgery
• Intervention / Treatment: Device: The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael D. Kluger, MD, MPH; Phone Number: 212-263-2630; Email: Michael.Kluger@nyulangone.org
• Study Contact Backup: Name: Madeleine D. Hunter; Phone Number: 212-263-2630; Email: Madeleine.hunter@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form. Able to understand their disease and the exploratory nature of sRBC transfusion during surgery for this histology.
2. Patient is 18 years of age or older
3. Patient has a diagnosis of cytologically or pathologically confirmed pancreatic adenocarcinoma
4. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
5. Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1-4
6. Life expectancy of greater than six months
7. Hemoglobin > 8.9 g/dl
8. Platelet count greater than 200,000/mm3
9. International Normalization Ratio ≤1.8
10. Total serum bilirubin ≤ 2 mg/dL
11. Serum creatinine ≤ 1.5 mg/dl
12. Recovered from any hematologic toxicity less than grade 3 from all prior chemotherapy or radiotherapy, and be at least 14 days past the date of their last treatment.

Exclusion Criteria:

1. Concomitant medical problems that would place the patient at unacceptable risk for a major surgical procedure.
2. History of congestive heart failure and/or an LVEF <40%.
3. Metastases
4. Active systemic infections, hematological diseases, coagulation disorders or other major medical illnesses of the cardiovascular, hepatic, renal, respiratory or immune system.
5. Patients with transabdominal drains, or peripancreatic abscess or fluid collections on cross-sectional imaging.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous group - sRBC; 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	Device: The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System; A cell salvage device will be utilized to collect all spilled blood during the course of the operative resection and vascular reconstruction.
Experimental: Allogeneic group - aRBC; 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.	Device: The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System; A cell salvage device will be utilized to collect all spilled blood during the course of the operative resection and vascular reconstruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of sepsis within 72 hours of operations	within 72 hours of operations
Rate of transfusion related complication within the first 72 hours	Up to 7 days post-operative
Rate of all adverse events in the first post-operate week	Up to 7 days post-operative

Secondary Outcome Measures

Outcome Measure	Time Frame
Units of aRBC required on post-operative day 0	Post-operative day 0 (up to 24 hours)]
Units of aRBC required on post-operative day 1-7	Post-operative days 1-7

Other Outcome Measures

Outcome Measure	Time Frame
Months until date of first biopsy or imaging evidence of progression, agreed upon by at multidisciplinary conference or months until death, if death occurs without disease progression	Until study completion (up to 5 years)
Months until date of death from any cause	Until study completion (up to 5 years)]

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Michael D. Kluger, MD, MPH, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Transfusion; Cell Salvage
• Other Study ID Numbers: 25-01196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The sample size in this exploratory study is small such that data sharing may risk breaching confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes