NYU Langone Health
New York, 10016, United States
NCT Number: NCT07598357
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
New York, 10016, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A cell salvage device will be utilized to collect all spilled blood during the course of the operative resection and vascular reconstruction.
Time frame: within 72 hours of operations
Time frame: Up to 7 days post-operative
Time frame: Up to 7 days post-operative
Time frame: Post-operative day 0 (up to 24 hours)]
Time frame: Post-operative days 1-7
Time frame: Until study completion (up to 5 years)
Time frame: Until study completion (up to 5 years)]
Contact information is provided by the study sponsor or research team.
Madeleine D. Hunter
CONTACT
Michael D. Kluger, MD, MPH
CONTACT
NYU Langone Health
Other
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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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