Salvaged Red Blood Cell Transfusion During Pancreatic Adenocarcinoma Operations

NYU Langone Health

Status: Begins enrollment this month

Conditions: Pancreatic Surgery

Treatments: Device: The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System

Study type: Interventional

Funder types: Other

Identifiers

NCT07598357

25-01196

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Autologous group - sRBC

Experimental group

Description:

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

Treatment:

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

Allogeneic group - aRBC

Experimental group

Description:

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.

Treatment:

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