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The purpose of this study is to prospectively study the safety of salvage red blood cell (sRBC) transfusion during pancreatic surgery.
Primary Objective:
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous group - sRBC | Experimental | 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 |
|
| Allogeneic group - aRBC | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Until study completion (up to 5 years) | |
| Months until date of death from any cause |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael D. Kluger, MD, MPH | Contact | 212-263-2630 | Michael.Kluger@nyulangone.org | |
| Madeleine D. Hunter | Contact | 212-263-2630 | Madeleine.hunter@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Michael D. Kluger, MD, MPH | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The sample size in this exploratory study is small such that data sharing may risk breaching confidentiality.
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| Until study completion (up to 5 years)] |