Pancreatic Surgery
Conditions
Keywords
Cell Salvage, Transfusion
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. 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.
Interventions
DEVICEThe 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.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| 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 |
Countries
United States
Contacts
CONTACTMichael D. Kluger, MD, MPH
CONTACTMadeleine D. Hunter
PRINCIPAL_INVESTIGATORMichael D. Kluger, MD, MPH
NYU Langone Health
Outcome results
None listed