Salvaged Red Blood Cell Transfusion During Pancreatic Adenocarcinoma Operations
ConditionPancreatic Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov