Trial Outcomes & Findings for Microparticles in Stored RBC as Potential Mediators of Transfusion Complications (NCT NCT01185600)
NCT ID: NCT01185600
Last Updated: 2017-07-02
Results Overview
The number of participants who expired during hospital stay after CABG surgery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
177 participants
Primary outcome timeframe
Within 30 days after CABG surgery
Results posted on
2017-07-02
Participant Flow
Participant milestones
| Measure |
Transfusion With Washed RBC
Subject assigned to this arm will be transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
|
Transfusion With Unwashed RBC
Subjects assigned to this arm will be transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
104
|
|
Overall Study
COMPLETED
|
41
|
59
|
|
Overall Study
NOT COMPLETED
|
32
|
45
|
Reasons for withdrawal
| Measure |
Transfusion With Washed RBC
Subject assigned to this arm will be transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
|
Transfusion With Unwashed RBC
Subjects assigned to this arm will be transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
|
Overall Study
Physician Decision
|
29
|
35
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Hold by DSMB
|
1
|
2
|
Baseline Characteristics
Microparticles in Stored RBC as Potential Mediators of Transfusion Complications
Baseline characteristics by cohort
| Measure |
Transfusion With Washed RBC
n=41 Participants
Subject assigned to this arm will be transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
|
Transfusion With Unwashed RBC
n=59 Participants
Subjects assigned to this arm will be transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
59 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
CD41+ platelet microparticles
|
11858 counts / uL
STANDARD_DEVIATION 10066 • n=5 Participants
|
12118 counts / uL
STANDARD_DEVIATION 10517 • n=7 Participants
|
12009 counts / uL
STANDARD_DEVIATION 10279 • n=5 Participants
|
|
CD235a+ red cell microparticles
|
2017 counts / uL
STANDARD_DEVIATION 2414 • n=5 Participants
|
1862 counts / uL
STANDARD_DEVIATION 1719 • n=7 Participants
|
1927 counts / uL
STANDARD_DEVIATION 2029 • n=5 Participants
|
|
CD62E+ endothelial microparticles
|
297 counts / uL
STANDARD_DEVIATION 430 • n=5 Participants
|
296 counts / uL
STANDARD_DEVIATION 446 • n=7 Participants
|
296 counts / uL
STANDARD_DEVIATION 435 • n=5 Participants
|
|
Annexin V+ microparticles
|
9171 counts / uL
STANDARD_DEVIATION 10710 • n=5 Participants
|
6637 counts / uL
STANDARD_DEVIATION 6518 • n=7 Participants
|
7697 counts / uL
STANDARD_DEVIATION 8568 • n=5 Participants
|
PRIMARY outcome
Timeframe: Within 30 days after CABG surgeryThe number of participants who expired during hospital stay after CABG surgery
Outcome measures
| Measure |
Transfusion With Washed RBC
n=41 Participants
Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
|
Transfusion With Unwashed RBC
n=59 Participants
Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
|
|---|---|---|
|
In Hospital Mortality
|
0 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Within one year after CABG surgeryPopulation: During the 12 months after hospital discharge, one participant in the group of transfusion with washed RBC and 3 participants in the group of transfusion with unwashed RBC were lost to follow up.
Number participants who expired within one year after CABG surgery
Outcome measures
| Measure |
Transfusion With Washed RBC
n=40 Participants
Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
|
Transfusion With Unwashed RBC
n=56 Participants
Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
|
|---|---|---|
|
One-year Mortality
|
0 participants
|
7 participants
|
PRIMARY outcome
Timeframe: within 30 days after CABG surgeryComparison of the two groups with respect to occurrence or not of at least one SAE including sepsis, respiratory failure, multi-organ failure, anaphylactic shock, transfusion-related acute lung injury, MI, stroke, cardiac arrest.
Outcome measures
| Measure |
Transfusion With Washed RBC
n=41 Participants
Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
|
Transfusion With Unwashed RBC
n=59 Participants
Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
|
|---|---|---|
|
Occurrence of at Least One Serious Adverse Event (SAE)
|
7 participants
|
6 participants
|
PRIMARY outcome
Timeframe: interval between presurgery and 1 hour post-surgeryPopulation: There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of "Transfusion with unwashed RBC". Therefore, the total number is 57 instead of 59 in that group.
Difference in levels of circulating CD41+ platelet microparticles between at pre-surgery and at 1hour post-surgery, i.e. level at 1hour post-surgery - level at pre-surgery
Outcome measures
| Measure |
Transfusion With Washed RBC
n=41 Participants
Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
|
Transfusion With Unwashed RBC
n=57 Participants
Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
|
|---|---|---|
|
Difference in Levels of Circulating CD41+ Platelet-derived Microparticles 1 Hour Post-surgery
|
-1059 counts / uL
Standard Deviation 9165
|
2034 counts / uL
Standard Deviation 9077
|
PRIMARY outcome
Timeframe: Interval between pre-surgery and 1 hour post-surgeryPopulation: There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of "Transfusion with unwashed RBC". Therefore, the total number is 57 instead of 59 in that group.
Difference in levels of circulating Annexin V+ microparticles between at pre-surgery and 1 hour post-surgery, i.e. level of Annexin V+ microparticles at 1 hour post-surgery - level of Annexin V+ microparticles at pre-surgery
Outcome measures
| Measure |
Transfusion With Washed RBC
n=40 Participants
Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
|
Transfusion With Unwashed RBC
n=57 Participants
Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
|
|---|---|---|
|
Difference in Levels of Circulating Annexin V+ Microparticles 1 Hour Post- Surgery
|
-3589 counts / uL
Standard Deviation 10940
|
-680 counts / uL
Standard Deviation 6022
|
PRIMARY outcome
Timeframe: Interval between pre-surgery and 1 hour post-surgeryPopulation: There were 2 participants' blood samples were not performed due to clotting or missing samples in the Group of "Transfusion with unwashed RBC". Therefore, the total number is 57 instead of 59 in that group.
Difference in levels of circulating CD62E+ endothelial microparticles between 1 hour post-surgery and at pre-surgery, i.e. level at 1 hour post-surgery - level at pre-surgery
Outcome measures
| Measure |
Transfusion With Washed RBC
n=41 Participants
Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
|
Transfusion With Unwashed RBC
n=57 Participants
Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
|
|---|---|---|
|
Difference in Levels of Circulating CD62E+ Endothelial Microparticles 1 Hour Post-surgery
|
36.4 counts / uL
Standard Deviation 176.5
|
2.0 counts / uL
Standard Deviation 59.1
|
PRIMARY outcome
Timeframe: Interval between pre-surgery and 1 hour post-surgeryDifference in levels of circulating CD235a+ red cell microparticles between at 1 hour post-surgery and at pre-surgery, i.e. levels at 1 hour post-surgery - level at pre-surgery
Outcome measures
| Measure |
Transfusion With Washed RBC
n=41 Participants
Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
|
Transfusion With Unwashed RBC
n=57 Participants
Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
|
|---|---|---|
|
Difference in Levels of Circulating CD235a+ Red Cell Microparticles 1 Hour Post-surgery
|
-344 counts / uL
Standard Deviation 2576
|
-208 counts / uL
Standard Deviation 1070
|
SECONDARY outcome
Timeframe: Within 30 days after CABG surgeryAll clinical non-serious adverse events reported in the clinical chart were recorded in the study's data files. This type of events, defined as Non-Serious Adverse Events or just Adverse Events (AEs) were categorized into 5 groups: (1) Cardiovascular / respiratory; (2) renal; (3) neurologic (CNS); (4) infections; and (5) other. For each participant, the outcome measure was defined as the number of AE's he or she experienced during his/her hospital stay.
Outcome measures
| Measure |
Transfusion With Washed RBC
n=41 Participants
Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
|
Transfusion With Unwashed RBC
n=59 Participants
Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
|
|---|---|---|
|
Each Participant's Number of Non-serious Adverse Events
|
1.5 Adverse events
Standard Deviation 1.1
|
2.4 Adverse events
Standard Deviation 2.2
|
Adverse Events
Transfusion With Washed RBC
Serious events: 7 serious events
Other events: 21 other events
Deaths: 0 deaths
Transfusion With Unwashed RBC
Serious events: 6 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Transfusion With Washed RBC
n=41 participants at risk
Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
|
Transfusion With Unwashed RBC
n=59 participants at risk
Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
|
|---|---|---|
|
Cardiac disorders
MI
|
12.2%
5/41 • Number of events 5 • Within 30 days after CABG surgery
|
6.8%
4/59 • Number of events 4 • Within 30 days after CABG surgery
|
|
Renal and urinary disorders
Renal Failure
|
2.4%
1/41 • Number of events 1 • Within 30 days after CABG surgery
|
3.4%
2/59 • Number of events 2 • Within 30 days after CABG surgery
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.4%
1/41 • Number of events 1 • Within 30 days after CABG surgery
|
3.4%
2/59 • Number of events 2 • Within 30 days after CABG surgery
|
Other adverse events
| Measure |
Transfusion With Washed RBC
n=41 participants at risk
Subjects assigned to this arm were transfused with washed RBC
Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
|
Transfusion With Unwashed RBC
n=59 participants at risk
Subjects assigned to this arm were transfused with unwashed RBC
Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
|
|---|---|---|
|
Nervous system disorders
Neurologic AE
|
17.1%
7/41 • Number of events 7 • Within 30 days after CABG surgery
|
16.9%
10/59 • Number of events 10 • Within 30 days after CABG surgery
|
|
Vascular disorders
CVD
|
39.0%
16/41 • Number of events 16 • Within 30 days after CABG surgery
|
52.5%
31/59 • Number of events 31 • Within 30 days after CABG surgery
|
|
Infections and infestations
Infection
|
7.3%
3/41 • Number of events 3 • Within 30 days after CABG surgery
|
6.8%
4/59 • Number of events 4 • Within 30 days after CABG surgery
|
|
Renal and urinary disorders
Renal
|
2.4%
1/41 • Number of events 1 • Within 30 days after CABG surgery
|
11.9%
7/59 • Number of events 7 • Within 30 days after CABG surgery
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
22.0%
9/41 • Number of events 9 • Within 30 days after CABG surgery
|
30.5%
18/59 • Number of events 18 • Within 30 days after CABG surgery
|
|
Blood and lymphatic system disorders
Thrombosis
|
2.4%
1/41 • Number of events 1 • Within 30 days after CABG surgery
|
1.7%
1/59 • Number of events 1 • Within 30 days after CABG surgery
|
|
Infections and infestations
Fever
|
2.4%
1/41 • Number of events 1 • Within 30 days after CABG surgery
|
0.00%
0/59 • Within 30 days after CABG surgery
|
Additional Information
Wenche Jy, PhD, Research Associate Professor, Principal Investigator
University of Miami
Phone: 305-243-6617
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place