Salvaged Red Blood Cell Transfusion During Pancreatic Adenocarcinoma Operations

Conditions

• Pancreatic Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System — DEVICE
  A cell salvage device will be utilized to collect all spilled blood during the course of the operative resection and vascular reconstruction.

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

May 2026

Primary completion

May 31, 2028

Completion

Jun 30, 2031

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Autologous group - sRBC
  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
• Experimental: Allogeneic group - aRBC
  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.

Primary Outcome Measure

Rate of sepsis within 72 hours of operations [ Time Frame: within 72 hours of operations ]

Central Contacts

• Michael D. Kluger, MD, MPH
  212-263-2630
  [email protected]
• Madeleine D. Hunter
  212-263-2630
  [email protected]

Locations (1)

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