Resectable Pancreatic CarcinomaEarly Phase 1NCT05841706
Red Blood Cell Transfusion Thresholds for Improved Quality of Life for Patients Undergoing a Pancreatectomy for Pancreatic Cancer
A Early Phase 1 study testing Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL), Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL) and Computed Tomography in people with Resectable Pancreatic Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Carcinoma
- What is being tested?
- Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL), Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL) and Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2023to 17 Mar 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- CT evidence of a mass in the pancreas consistent with cancer
- Tissue diagnosis of cancer either before surgery or from the resected specimen
- Preoperative evaluation suggestive that pancreatic resection is feasible
- 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
Who cannot join
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Patients who are unable to receive or who refuse blood products
- Patients involved in an autologous pre-donation program
- Patients found to have metastatic disease upon entry into abdomen-having been randomized, these patients will be removed from the study and replaced with another patient
- Patients found to not have cancer during the operation- If the resected lesion proves not to be cancer, the patient will remain as an enrolled patient but not evaluable and replaced by another patient
- Established severe cardiovascular disease with estimated 5-year survival <10% based on Framingham risk score
- Unstable angina or recent myocardial infarction (MI)/stroke within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at Los Angeles
Los Angeles, California, 90095-1406
About this study
Official title: Open Label Randomized Trial of Blood Transfusions in Cancer Patients Following a Pancreatectomy: A Feasibility Study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- The primary objective for this pilot study is protocol adherence for the transfusion study we propose for pancreatectomy patients.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Resectable Pancreatic Carcinoma
- Being tested
- Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL), Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL), Computed Tomography, X-Ray Imaging, Biospecimen Collection
- Keywords
- pancreatectomy, Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL)Biological
Also called PRBC Transfusion
Receive conservative transfusion strategy (Hgb < 7 g/dL)
Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL)Biological
Also called PRBC Transfusion
Receive liberal transfusion strategy (Hgb < 9 g/dL)
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, CAT scan, CAT Scan, Computed Axial Tomography, Computed Tomography, computed tomography
Undergo CT scan
X-Ray ImagingProcedure or surgery
Also called Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Radiographic Imaging, Radiography, RG, Static X-Ray, X-RAY, X-Ray, X-Ray, X-Ray, X-Ray
Undergo x-ray imaging
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection
Undergo blood sample collection
Survey AdministrationOther
Ancillary studies
PancreatectomyProcedure or surgery
surgical removal of all or part of pancreas
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL); Procedure: Computed Tomography; Procedure: X-Ray Imaging; Procedure: Biospecimen Collection; Other: Survey Administration; Procedure: Pancreatectomy |
| 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. Receives: Biological: Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL); Procedure: Computed Tomography; Procedure: X-Ray Imaging; Procedure: Biospecimen Collection; Other: Survey Administration; Procedure: Pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Protocol adherence
Will be measured as the proportion of patients who are enrolled in the study and do not experience major protocol
Measured: Up to 36 months post surgery
Secondary outcomes (5)
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.
Measured: 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.
Measured: Up to 36 months post operative
Length of stay in hospital and intensive care unit (ICU)
Measured: through study completion, an average of 1 year
Proportion of patients transfused
Measured: Up to hospital discharge or post operative day 28
Number of blood products received
Measured: Up to hospital discharge or post operative day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start10 Aug 2023
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Pancreatic CarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Livingston, MD, Principal investigator, University of California at Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841706
- Sponsor's protocol ID
- 22-001796
- Status last verified
- Jun 2025
- First submitted
- 12 Apr 2023
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Randomized Trial of Blood Transfusions in Cancer Patients Following a Pancreatectomy: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05841706
- Acronym / sponsor ID
- 22-001796
- Conditions
- Resectable Pancreatic Carcinoma
- Keywords
- pancreatectomy, Transfusion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- The primary objective for this pilot study is protocol adherence for the transfusion study we propose for pancreatectomy patients.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Transfusion for Hgb less than 7 g/dL) | Experimental | Biological: Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL), Procedure: Computed Tomography, Procedure: X-Ray Imaging, Procedure: Biospecimen Collection, Other: Survey Administration, Procedure: PancreatectomyPatients 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. |
| Arm II (Transfusion for Hgb less than 9 g/dL) | Experimental | Biological: Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL), Procedure: Computed Tomography, Procedure: X-Ray Imaging, Procedure: Biospecimen Collection, Other: Survey Administration, Procedure: PancreatectomyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Patients who are unable to receive or who refuse blood products
- Patients involved in an autologous pre-donation program
- Patients found to have metastatic disease upon entry into abdomen-having been randomized, these patients will be removed from the study and replaced with another patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL)Also: PRBC TransfusionReceive conservative transfusion strategy (Hgb < 7 g/dL) | Biological | Arm I (Transfusion for Hgb less than 7 g/dL) |
| Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL)Also: PRBC TransfusionReceive liberal transfusion strategy (Hgb < 9 g/dL) | Biological | Arm II (Transfusion for Hgb less than 9 g/dL) |
| Computed TomographyAlso: CAT, CAT Scan, CAT scan, CAT Scan, Computed Axial Tomography, Computed Tomography, computed tomographyUndergo CT scan | Procedure or surgery | Arm I (Transfusion for Hgb less than 7 g/dL), Arm II (Transfusion for Hgb less than 9 g/dL) |
| X-Ray ImagingAlso: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Radiographic Imaging, Radiography, RG, Static X-Ray, X-RAY, X-Ray, X-Ray, X-Ray, X-RayUndergo x-ray imaging | Procedure or surgery | Arm I (Transfusion for Hgb less than 7 g/dL), Arm II (Transfusion for Hgb less than 9 g/dL) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm I (Transfusion for Hgb less than 7 g/dL), Arm II (Transfusion for Hgb less than 9 g/dL) |
| Survey AdministrationAncillary studies | Other | Arm I (Transfusion for Hgb less than 7 g/dL), Arm II (Transfusion for Hgb less than 9 g/dL) |
| Pancreatectomysurgical removal of all or part of pancreas | Procedure or surgery | Arm I (Transfusion for Hgb less than 7 g/dL), Arm II (Transfusion for Hgb less than 9 g/dL) |
Primary outcome
Rate of Protocol adherence
Time frame: Up to 36 months post surgery
Will be measured as the proportion of patients who are enrolled in the study and do not experience major protocol
5 secondary outcomes
Health related quality of life
Time frame: At preoperative visit, post operative period, months 1, 3, 6, 9, 12, 24, 27, 30, 33, 36
Incidence of significant individual adverse events
Time frame: Up to 36 months post operative
Length of stay in hospital and intensive care unit (ICU)
Time frame: through study completion, an average of 1 year
Proportion of patients transfused
Time frame: Up to hospital discharge or post operative day 28
Number of blood products received
Time frame: Up to hospital discharge or post operative day 28
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Livingston, MD principal investigator
University of California at Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL), Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL) and Computed Tomography in people with Resectable Pancreatic Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Protocol adherence (time frame: Up to 36 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.