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NCT Number: NCT07598357

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Rate of sepsis within 72 hours of operations

    Time frame: within 72 hours of operations

  2. Rate of transfusion related complication within the first 72 hours

    Time frame: Up to 7 days post-operative

  3. Rate of all adverse events in the first post-operate week

    Time frame: Up to 7 days post-operative

Secondary outcomes

  1. Units of aRBC required on post-operative day 0

    Time frame: Post-operative day 0 (up to 24 hours)]

  2. Units of aRBC required on post-operative day 1-7

    Time frame: Post-operative days 1-7

Other outcomes

  1. 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

    Time frame: Until study completion (up to 5 years)

  2. Months until date of death from any cause

    Time frame: Until study completion (up to 5 years)]

Study contacts

Contact information is provided by the study sponsor or research team.

Madeleine D. Hunter

CONTACT

[email protected]

212-263-2630

Michael D. Kluger, MD, MPH

CONTACT

[email protected]

212-263-2630

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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