Salvaged Red Blood Cell Transfusion During Pancreatic Adenocarcinoma Operations

NCT07598357 | Not Yet Recruiting FDA Device

• 1 other identifier: 25-01196
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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. 3.To summarize rates and timing of AEs in the first 7 post-operative days.
4. 4.To summarize the number of units of aRBC transfused post operative day (POD) #0 after sRBC transfusion in the operating room.
5. 5.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.

Conditions

Pancreatic Surgery

Keywords

Cell Salvage; Transfusion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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 Outcomes (2)

• 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)]

Study Arms (2)

Autologous group - sRBC

EXPERIMENTAL

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

Allogeneic group - aRBC

EXPERIMENTAL

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

Interventions

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

A cell salvage device will be utilized to collect all spilled blood during the course of the operative resection and vascular reconstruction.

Allogeneic group - aRBC; Autologous group - sRBC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient is 18 years of age or older
• Patient has a diagnosis of cytologically or pathologically confirmed pancreatic adenocarcinoma
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1-4
• Life expectancy of greater than six months
• Hemoglobin \> 8.9 g/dl
• Platelet count greater than 200,000/mm3
• International Normalization Ratio ≤1.8
• Total serum bilirubin ≤ 2 mg/dL
• Serum creatinine ≤ 1.5 mg/dl
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Michael D. Kluger, MD, MPH

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael D. Kluger, MD, MPH

CONTACT

212-263-2630; Michael.Kluger@nyulangone.org

Madeleine D. Hunter

CONTACT

212-263-2630; Madeleine.hunter@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2031
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)