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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System
DeviceA cell salvage device will be utilized to collect all spilled blood during the course of the operative resection and vascular reconstruction.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Autologous group - sRBCExperimental treatment 1 intervention
Group B: Allogeneic group - aRBCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of sepsis within 72 hours of operations
Time frame
within 72 hours of operations2
Rate of transfusion related complication within the first 72 hours
Time frame
Up to 7 days post-operative3
Rate of all adverse events in the first post-operate week
Time frame
Up to 7 days post-operativeSecondary outcomes
1
Units of aRBC required on post-operative day 0
Time frame
Post-operative day 0 (up to 24 hours)]2
Units of aRBC required on post-operative day 1-7
Time frame
Post-operative days 1-7Other outcomes
1
Months until date of first biopsy or imaging evidence of progression, agreed upon by at multidisciplinary conference or months until death, if death occurs without disease progression
Time frame
Until study completion (up to 5 years)2
Months until date of death from any cause
Time frame
Until study completion (up to 5 years)]Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: