Pancreatic SurgeryNCT07598357
Salvaged Red Blood Cell Transfusion During Pancreatic Adenocarcinoma Operations
A study testing The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System in people with Pancreatic Surgery, run by NYU Langone Health at 1 site in United States.
Trial 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. 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Surgery
- What is being tested?
- The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to prospectively study the safety of salvage red blood cell (sRBC) transfusion during pancreatic surgery.
Primary Objective:
Read more
- 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.
- To summarize rates and timing of transfusion related AEs for patients who receive sRBC or aRBC transfusions within 72 hours of peri-operative transfusion.
- To summarize rates and timing of AEs in the first 7 post-operative days.
Secondary Objectives:
- To summarize the number of units of aRBC transfused post operative day (POD) #0 after sRBC transfusion in the operating room.
- 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
- Being tested
- The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System
- Keywords
- Cell Salvage, Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion SystemDevice
A cell salvage device will be utilized to collect all spilled blood during the course of the operative resection and vascular reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of sepsis within 72 hours of operations
Measured: within 72 hours of operations
Rate of transfusion related complication within the first 72 hours
Measured: Up to 7 days post-operative
Rate of all adverse events in the first post-operate week
Measured: Up to 7 days post-operative
Secondary outcomes (2)
Units of aRBC required on post-operative day 0
Measured: Post-operative day 0 (up to 24 hours)]
Units of aRBC required on post-operative day 1-7
Measured: Post-operative days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study startJun 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic SurgeryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael D. Kluger, MD, MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598357
- Sponsor's protocol ID
- 25-01196
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The sample size in this exploratory study is small such that data sharing may risk breaching confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvaged Red Blood Cell Transfusion During Pancreatic Adenocarcinoma Operations
- ClinicalTrials.gov ID
- NCT07598357
- Acronym / sponsor ID
- 25-01196
- Conditions
- Pancreatic Surgery
- Keywords
- Cell Salvage, Transfusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to prospectively study the safety of salvage red blood cell (sRBC) transfusion during pancreatic surgery.
Primary Objective:
- 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.
- To summarize rates and timing of transfusion related AEs for patients who receive sRBC or aRBC transfusions within 72 hours of peri-operative transfusion.
- To summarize rates and timing of AEs in the first 7 post-operative days.
Secondary Objectives:
- To summarize the number of units of aRBC transfused post operative day (POD) #0 after sRBC transfusion in the operating room.
- 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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous group - sRBC | Experimental | Device: The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion SystemPatients 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 |
| Allogeneic group - aRBC | Experimental | Device: The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion SystemPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion SystemA cell salvage device will be utilized to collect all spilled blood during the course of the operative resection and vascular reconstruction. | Device | Allogeneic group - aRBC, Autologous group - sRBC |
Primary outcome
Rate of sepsis within 72 hours of operations
Time frame: within 72 hours of operations
Rate of transfusion related complication within the first 72 hours
Time frame: Up to 7 days post-operative
Rate of all adverse events in the first post-operate week
Time frame: Up to 7 days post-operative
2 secondary outcomes
Units of aRBC required on post-operative day 0
Time frame: Post-operative day 0 (up to 24 hours)]
Units of aRBC required on post-operative day 1-7
Time frame: Post-operative days 1-7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. The sample size in this exploratory study is small such that data sharing may risk breaching confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael D. Kluger, MD, MPH principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System in people with Pancreatic Surgery, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael D. Kluger, MD, MPH (212-263-2630, Michael.Kluger@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of sepsis within 72 hours of operations (time frame: within 72 hours of operations). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.