Immunomodulation Following Transfusion

NCT00810810 | Completed Phase 4 Results

• 2 other identifiers: 297921P50HL081015
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to provide information on patients' immune response after exposure to transfused blood. Blood transfusions may have opposite immune effects on patients. One is sensitization. The other is immunosuppression. The magnitude of these effects in patients who are not on chemotherapy is unknown. These effects are thought to be due largely to white blood cells present in the transfusion product. "Leukofiltration" and "gamma-irradiation" are the special treatments that deplete white blood cells. A combination of leukofiltration and gamma-irradiation pretreatment of donor blood is thought to deplete the white blood cells most effectively. In this study, patients scheduled for cardiac surgery are randomly assigned to receive blood products pretreated in one of three ways: untreated, filtered or filtered and irradiated. If their physician orders transfusions, they will receive products assigned to their group. Patients are asked to provide two blood samples during the 4 weeks after surgery. Studies will measure changes in antibody to HLA and in cells that regulate the immune response. The levels of sensitization and immunosuppression will be correlated to the transfusion products received.

Conditions

Blood Component Transfusion

Keywords

Blood Component Transfusion; Leukoreduction; HLA antibody; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Changes in the Production of Antibody to HLA Antigens

  Blood samples were collected prior to surgery and at two times after surgery. Serum was tested for the presence of IgG antibody to HLA. the results of the samples collected after surgery were compared to those in the sample collected prior to surgery.

  0 to 5 weeks after surgery

Secondary Outcomes (1)

• Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines

  0 to 5 weeks after surgery

Study Arms (3)

1

ACTIVE COMPARATOR

Blood components with no additional treatment

Biological: Standard blood components

2

EXPERIMENTAL

Blood components leukoreduced

Biological: Leukoreduced blood components

3

EXPERIMENTAL

Blood components leukoreduced and irradiated

Biological: Leukoreduced and irradiated

Interventions

Standard blood components BIOLOGICAL

Transfusion, if ordered by physician, with unfiltered red blood cells and apheresis platelets

1

Leukoreduced blood components BIOLOGICAL

Transfusion, if ordered by a physician, of leukoreduced red blood cells and apheresis platelets

2

Leukoreduced and irradiated BIOLOGICAL

Transfusion, if ordered by physician, of gamma irradiated leukoreduced red blood cells and gamma irradiated apheresis platelets

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 year of age
• Scheduled for open heart surgery of cardiopulmonary bypass that involves: CABG, CABG with valve, aneurysm repair
• Urgent or elective surgery

You may not qualify if:

• Scheduled for open heart surgery of cardiopulmonary bypass that involves: placement of a ventricular assist device, cardiac transplantation, aortic dissection repair
• Emergent surgery
• participation in other clinical research studies within 30 days of randomization.
• Immunosuppressive treatment.
• Refuse blood transfusion
• Disease or condition placing subject at undue risk or decision of attending doctor.
• Condition requiring high volume transfusion therapy

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Bloodworks: collaborator

Study Sites (2)

Northwest Hospital

Seattle, Washington, 98133, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Nelson KA, Aldea GS, Warner P, Latchman Y, Gunasekera D, Tamir A, Gernsheimer T, Bolgiano D, Slichter SJ. Transfusion-related immunomodulation: gamma irradiation alters the effects of leukoreduction on alloimmunization. Transfusion. 2019 Nov;59(11):3396-3404. doi: 10.1111/trf.15555. Epub 2019 Oct 13.

  PMID: 31608454 DERIVED

MeSH Terms

Interventions

Radiation

Intervention Hierarchy (Ancestors)

Physical Phenomena

Results Point of Contact

• Title: Karen Nelson, PhD., Vice President Laboratories
• Organization: Bloodworks Northwest (formerly Puget Sound Blood Center)

knelson@bloodworksnw.org

206-689-6549

Study Officials

• Karen Nelson, PhD

  Bloodworks

  PRINCIPAL INVESTIGATOR

• Gabriel Aldea, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical teams caring for patients were not masked. Laboratory personnel were masked until all testing completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Individuals who consented for study were scheduled for cardiac surgery. They were randomized to one of three arms to receive blood components prepared by different, but clinically acceptable processes. If they required transfusion from 2 days prior to surgery until 30 days post surgery they received study product. Blood samples were collected prior to surgery and at two points after surgery.

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: July 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2011
• Last Updated: December 26, 2017
• Results First Posted: November 29, 2017

Record last verified: 2017-11

Locations

US (2)