Trial Outcomes & Findings for Immunomodulation Following Transfusion (NCT NCT00810810)
NCT ID: NCT00810810
Last Updated: 2017-12-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
287 participants
Primary outcome timeframe
0 to 5 weeks after surgery
Results posted on
2017-12-26
Participant Flow
Patients scheduled for cardiac surgery at the U. Washington or an affiliated program at Northwest Hospital had the study explained to them by the clinical team including a clinical research coordinator and consent was obtained. Recruitment began in August of 2006 and extended until August of 2010.
There were 7 individuals who consented but were not randomized: late discovery of exclusionary criteria, surgery cancelled, individual withdrew.
Participant milestones
| Measure |
4. No Transfusion
This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
|
1. Standard
Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
2. Leukoreduced
Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
3. Leukoreduced Gamma Irradiated
Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
124
|
49
|
56
|
51
|
|
Overall Study
COMPLETED
|
124
|
38
|
45
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
11
|
11
|
13
|
Reasons for withdrawal
| Measure |
4. No Transfusion
This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
|
1. Standard
Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
2. Leukoreduced
Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
3. Leukoreduced Gamma Irradiated
Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
8
|
10
|
8
|
|
Overall Study
Physician Decision
|
0
|
3
|
1
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
4. No Transfusion
n=124 Participants
This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
|
1. Standard
n=38 Participants
Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
2. Leukoreduced
n=45 Participants
Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
3. Leukoreduced Gamma Irradiated
n=38 Participants
Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18 Years and older
|
124 Participants
n=124 Participants
|
38 Participants
n=38 Participants
|
45 Participants
n=45 Participants
|
38 Participants
n=38 Participants
|
245 Participants
n=245 Participants
|
|
Sex/Gender, Customized
unknown
|
124 Participants
n=124 Participants
|
38 Participants
n=38 Participants
|
45 Participants
n=45 Participants
|
38 Participants
n=38 Participants
|
245 Participants
n=245 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
124 participants
n=124 Participants
|
38 participants
n=38 Participants
|
45 participants
n=45 Participants
|
38 participants
n=38 Participants
|
245 participants
n=245 Participants
|
PRIMARY outcome
Timeframe: 0 to 5 weeks after surgeryPopulation: Antibody tests were invalid for some participants in Arm 1. Their sera contained interfering substances.
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.
Outcome measures
| Measure |
4. No Transfusion
n=124 Participants
This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
|
1. Standard
n=38 Participants
Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
2. Leukoreduced
n=45 Participants
Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
3. Leukoreduced Gamma Irradiated
n=38 Participants
Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
|---|---|---|---|---|
|
Number of Participants With Changes in the Production of Antibody to HLA Antigens
Baseline antibody negative, antibody increased
|
2 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Changes in the Production of Antibody to HLA Antigens
Baseline antibody positive, antibody increased
|
11 Participants
|
10 Participants
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 0 to 5 weeks after surgeryPopulation: The study used stringent criteria for acceptance of these cellular assays. Invalid tests were not included in the analysis, therefor the numbers reported in the Outcome Measures table do not add up to the number analyzed for each test.
Blood samples were collected prior to surgery and at two times after surgery. White blood cells were isolated and frozen. The thawed cells were tested for the numbers and phenotype of regulatory cells and for the production of regulatory cytokines. Results obtained from samples collected after surgery were compared to the results obtained from the sample collected prior to surgery.
Outcome measures
| Measure |
4. No Transfusion
n=71 Participants
This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis.
|
1. Standard
n=20 Participants
Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
2. Leukoreduced
n=25 Participants
Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
3. Leukoreduced Gamma Irradiated
n=23 Participants
Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery).
|
|---|---|---|---|---|
|
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
Number of MNC producing TGFB1 · Increased
|
30 Participants
|
11 Participants
|
12 Participants
|
7 Participants
|
|
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
Number of MNC producing TGFB1 · Not increased
|
37 Participants
|
7 Participants
|
11 Participants
|
12 Participants
|
|
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
Number of CD4+ IL4+ iNKT cells · Increased
|
22 Participants
|
10 Participants
|
15 Participants
|
4 Participants
|
|
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
Number of CD4+ IL4+ iNKT cells · Not increased
|
48 Participants
|
9 Participants
|
10 Participants
|
19 Participants
|
|
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
Number of CD4+ IFNg+ iNKT cells · Increased
|
9 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
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
Number of CD4+ IFNg+ iNKT cells · Not increased
|
61 Participants
|
18 Participants
|
23 Participants
|
22 Participants
|
|
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
Number of CD4- IL4+ iNKT cells · Increased
|
17 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
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
Number of CD4- IL4+ iNKT cells · Not increased
|
53 Participants
|
18 Participants
|
23 Participants
|
22 Participants
|
|
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
Number of CD4- INFg+ iNKT cells · Increased
|
13 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
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
Number of CD4- INFg+ iNKT cells · Not increased
|
57 Participants
|
18 Participants
|
24 Participants
|
21 Participants
|
|
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
IL-10 produced by PBMC · Increased
|
45 Participants
|
14 Participants
|
16 Participants
|
8 Participants
|
|
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
IL-10 produced by PBMC · Not increased
|
26 Participants
|
5 Participants
|
7 Participants
|
15 Participants
|
|
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
CD4+Number of CD25+FoxP3+ T cells · Increased
|
5 Participants
|
7 Participants
|
9 Participants
|
4 Participants
|
|
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
CD4+Number of CD25+FoxP3+ T cells · Not increased
|
59 Participants
|
13 Participants
|
15 Participants
|
16 Participants
|
|
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
Number of CD4+CD25+CTLA4+ T cells · Increased
|
8 Participants
|
9 Participants
|
11 Participants
|
3 Participants
|
|
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
Number of CD4+CD25+CTLA4+ T cells · Not increased
|
56 Participants
|
11 Participants
|
13 Participants
|
17 Participants
|
Adverse Events
4. No Transfusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1. Standard
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2. Leukoreduced
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3. Leukoreduced Gamma Irradiated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Karen Nelson, PhD., Vice President Laboratories
Bloodworks Northwest (formerly Puget Sound Blood Center)
Phone: 206-689-6549
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place