Open Label Randomized Trial of Blood Transfusions in Cancer Patients Following a Pancreatectomy: A Feasibility Study

Status: Terminated
Location: See location...
Intervention Type: Procedure, Biological, Other
Study Type: Interventional
Study Phase: Early Phase 1
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California at Los Angeles
Los Angeles
Time Frame
Start Date: 2023-08-10
Completion Date: 2025-03-17
Participants
Target number of participants: 1
Treatments
Experimental: Arm I (Transfusion for Hgb less than 7 g/dL)
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.
Experimental: Arm II (Transfusion for Hgb less than 9 g/dL)
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.
Sponsors
Leads: Jonsson Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov

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