Clinical trial · Interventional
Red Blood Cell Transfusion Thresholds for Improved Quality of Life for Patients Undergoing a Pancreatectomy for Pancreatic Cancer
Open Label Randomized Trial of Blood Transfusions in Cancer Patients Following a Pancreatectomy: A Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Resectable Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL) | Biological | — | UNRESOLVED |
| Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL) | Biological | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Pancreatectomy | Procedure | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
| X-Ray Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (Transfusion for Hgb less than 7 g/dL)
- description
- 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.
- interventionNames
- 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
- type
- EXPERIMENTAL
- label
- Arm II (Transfusion for Hgb less than 9 g/dL)
- description
- 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.
- interventionNames
- Biological: Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available