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This clinical trial tests the the feasibility of testing a red blood cell transfusion threshold for improved quality of life for patients undergoing a pancreatectomy for pancreatic cancer. Pancreatectomy can be associated with significant blood loss. Blood loss can result in clinically important anemia causing fatigue. Pancreatic cancer itself can be associated with malnutrition and fatigue. Having a red blood cell transfusion threshold that results in a more liberal use of transfusions may improve quality of life for patients undergoing a pancreatectomy for pancreatic cancer.
PRIMARY OBJECTIVE:
I. The primary objective for this pilot study is protocol adherence for the transfusion study we propose for pancreatectomy patients.
SECONDARY OBJECTIVES:
I. Determine the feasibility of collecting and processing of all data that will be collected in the full study.
II. Specific emphasis will be given to findings from Patient Reported Outcomes Measurement Information System (PROMIS)-29 to determine its sensitivity to changes in health related quality of life (HRQOL) that occur in the perioperative period after pancreatectomy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo red blood cell transfusion if hemoglobin (Hgb) is less than 7 g/dL while on study.
ARM II: Patients undergo red blood cell transfusion if Hgb is less than 9 g/dL while on study.
Patients undergo computed tomography (CT) scan, x ray imaging, and blood sample collection throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Transfusion for Hgb less than 7 g/dL) | Experimental | Patients undergo red blood cell transfusion if Hgb is less than 7 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study. |
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| Arm II (Transfusion for Hgb less than 9 g/dL) | Experimental | Patients undergo red blood cell transfusion if Hgb is less than 9 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL) | Biological | Receive conservative transfusion strategy (Hgb < 7 g/dL) |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Protocol adherence | Will be measured as the proportion of patients who are enrolled in the study and do not experience major protocol | Up to 36 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life | Will be assessed by Patient Reported Outcomes Measurement Information System (PROMIS)-29 v2.1. PROMIS, uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. a higher T-score represents more of the concept being measured. For negatively-worded concepts like fatigue, a higher T-score represents greater fatigue and a lower T-score represents less fatigue. For positively-worded concepts like physical function, a higher T-score reflects higher (better) physical function and a lower T-score reflects lower (worse) physical function. For NIH Toolbox performance tests of cognitive, motor, and sensory function, a higher score indicates better performance. |
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Inclusion Criteria:
Male or female >= 18 years of age at Visit 1
Documentation of a pancreatic cancer diagnosis as evidenced by one or more clinical features meeting the following criteria:
Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Livingston, MD | University of California at Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Los Angeles | Los Angeles | California | 90095-1406 | United States |
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| Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL) | Biological | Receive liberal transfusion strategy (Hgb < 9 g/dL) |
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| Computed Tomography | Procedure | Undergo CT scan |
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| X-Ray Imaging | Procedure | Undergo x-ray imaging |
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| Biospecimen Collection | Procedure | Undergo blood sample collection |
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| Survey Administration | Other | Ancillary studies |
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| Pancreatectomy | Procedure | surgical removal of all or part of pancreas |
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| At preoperative visit, post operative period, months 1, 3, 6, 9, 12, 24, 27, 30, 33, 36 |
| Incidence of significant individual adverse events | Will include major adverse cardiovascular events (MACE), surgical site infection (SSI), surgical site occurrence (SSO), clinically-relevant postoperative pancreatic fistula (CR-POPF), hemorrhage, pneumonia, urinary tract infection (UTI), reoperation, readmission, and mortality. Safety and tolerability data will be summarized by treatment group. Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug. | Up to 36 months post operative |
| Length of stay in hospital and intensive care unit (ICU) | through study completion, an average of 1 year |
| Proportion of patients transfused | Up to hospital discharge or post operative day 28 |
| Number of blood products received | Up to hospital discharge or post operative day 28 |
| ID | Term |
|---|---|
| D006454 | Hemoglobins |
| D014965 | X-Rays |
| D013048 | Specimen Handling |
| D010180 | Pancreatectomy |
| ID | Term |
|---|---|
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005914 | Globins |
| D006420 | Hemeproteins |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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