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Microparticles in Stored RBC as Potential Mediators of Transfusion Complications

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ClinicalTrials.gov Identifier: NCT01185600
Recruitment Status : Completed
First Posted : August 20, 2010
Results First Posted : November 23, 2016
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Wenche Jy, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Coronary Artery Bypass
Interventions Biological: Washed RBC
Biological: Unwashed RBC
Enrollment 177
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Transfusion With Washed RBC Transfusion With Unwashed RBC
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 73 104
Completed 41 59
Not Completed 32 45
Reason Not Completed
Adverse Event             1             1
Death             0             1
Lost to Follow-up             0             5
Physician Decision             29             35
Withdrawal by Subject             1             1
Hold by DSMB             1             2
Arm/Group Title Transfusion With Washed RBC Transfusion With Unwashed RBC Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 41 59 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 59 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
  58.5%
30
  50.8%
54
  54.0%
>=65 years
17
  41.5%
29
  49.2%
46
  46.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 59 participants 100 participants
61.7  (7.1) 63.9  (11.1) 63.0  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 59 participants 100 participants
Female
10
  24.4%
21
  35.6%
31
  31.0%
Male
31
  75.6%
38
  64.4%
69
  69.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 59 participants 100 participants
Hispanic or Latino
27
  65.9%
33
  55.9%
60
  60.0%
Not Hispanic or Latino
14
  34.1%
26
  44.1%
40
  40.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 59 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
   3.4%
2
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  24.4%
14
  23.7%
24
  24.0%
White
31
  75.6%
43
  72.9%
74
  74.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 59 participants 100 participants
41 59 100
CD41+ platelet microparticles   [1] 
Mean (Standard Deviation)
Unit of measure:  Counts / uL
Number Analyzed 41 participants 59 participants 100 participants
11858  (10066) 12118  (10517) 12009  (10279)
[1]
Measure Description: Cd41+ platelet microparticles is a specific biomarker for platelet activation
CD235a+ red cell microparticles   [1] 
Mean (Standard Deviation)
Unit of measure:  Counts / uL
Number Analyzed 41 participants 59 participants 100 participants
2017  (2414) 1862  (1719) 1927  (2029)
[1]
Measure Description: Cd235a+ red cell microparticles are a specific marker for red cell storage lesions. They may reflect the conditions of transfused RBC in circulation.
CD62E+ endothelial microparticles   [1] 
Mean (Standard Deviation)
Unit of measure:  Counts / uL
Number Analyzed 41 participants 59 participants 100 participants
297  (430) 296  (446) 296  (435)
[1]
Measure Description: CD62E+ endothelial microparticles are a specific marker for endothelial activation and apoptosis.
Annexin V+ microparticles   [1] 
Mean (Standard Deviation)
Unit of measure:  Counts / uL
Number Analyzed 41 participants 59 participants 100 participants
9171  (10710) 6637  (6518) 7697  (8568)
[1]
Measure Description: Annexin V+ microparticles are a marker for non-specific cell activation and apoptosis.
1.Primary Outcome
Title In Hospital Mortality
Hide Description The number of participants who expired during hospital stay after CABG surgery
Time Frame Within 30 days after CABG surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transfusion With Washed RBC Transfusion With Unwashed RBC
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 41 59
Measure Type: Number
Unit of Measure: participants
0 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transfusion With Washed RBC, Transfusion With Unwashed RBC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title One-year Mortality
Hide Description Number participants who expired within one year after CABG surgery
Time Frame Within one year after CABG surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Transfusion With Washed RBC Transfusion With Unwashed RBC
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 40 56
Measure Type: Number
Unit of Measure: participants
0 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transfusion With Washed RBC, Transfusion With Unwashed RBC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0391
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Primary Outcome
Title Occurrence of at Least One Serious Adverse Event (SAE)
Hide Description Comparison 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.
Time Frame within 30 days after CABG surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transfusion With Washed RBC Transfusion With Unwashed RBC
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 41 59
Measure Type: Number
Unit of Measure: participants
7 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transfusion With Washed RBC, Transfusion With Unwashed RBC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.372
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Primary Outcome
Title Difference in Levels of Circulating CD41+ Platelet-derived Microparticles 1 Hour Post-surgery
Hide Description 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
Time Frame interval between presurgery and 1 hour post-surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Transfusion With Washed RBC Transfusion With Unwashed RBC
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 41 57
Mean (Standard Deviation)
Unit of Measure: counts / uL
-1059  (9165) 2034  (9077)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transfusion With Washed RBC, Transfusion With Unwashed RBC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1007
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Primary Outcome
Title Difference in Levels of Circulating Annexin V+ Microparticles 1 Hour Post- Surgery
Hide Description 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
Time Frame Interval between pre-surgery and 1 hour post-surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Transfusion With Washed RBC Transfusion With Unwashed RBC
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 40 57
Mean (Standard Deviation)
Unit of Measure: counts / uL
-3589  (10940) -680  (6022)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transfusion With Washed RBC, Transfusion With Unwashed RBC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0964
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Primary Outcome
Title Difference in Levels of Circulating CD62E+ Endothelial Microparticles 1 Hour Post-surgery
Hide Description 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
Time Frame Interval between pre-surgery and 1 hour post-surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Transfusion With Washed RBC Transfusion With Unwashed RBC
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 41 57
Mean (Standard Deviation)
Unit of Measure: counts / uL
36.4  (176.5) 2.0  (59.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transfusion With Washed RBC, Transfusion With Unwashed RBC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1739
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Primary Outcome
Title Difference in Levels of Circulating CD235a+ Red Cell Microparticles 1 Hour Post-surgery
Hide Description Difference 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
Time Frame Interval between pre-surgery and 1 hour post-surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transfusion With Washed RBC Transfusion With Unwashed RBC
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 41 57
Mean (Standard Deviation)
Unit of Measure: counts / uL
-344  (2576) -208  (1070)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transfusion With Washed RBC, Transfusion With Unwashed RBC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7205
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
8.Secondary Outcome
Title Each Participant's Number of Non-serious Adverse Events
Hide Description All 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.
Time Frame Within 30 days after CABG surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transfusion With Washed RBC Transfusion With Unwashed RBC
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 41 59
Mean (Standard Deviation)
Unit of Measure: Adverse events
1.5  (1.1) 2.4  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transfusion With Washed RBC, Transfusion With Unwashed RBC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0176
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Negative Binomial
Estimated Value 1.64
Confidence Interval (2-Sided) 95%
1.06 to 2.55
Estimation Comments

Using Negative Binomial Regression the following ratio and corresponding 95% CI were obtained:

(# of AE’s, Unwashed Group / (# of AE’s, Washed Group) = 1.64 95% C.I. = [1.06 – 2.55]

Time Frame Within 30 days after CABG surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transfusion With Washed RBC Transfusion With Unwashed RBC
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Transfusion With Washed RBC Transfusion With Unwashed RBC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Transfusion With Washed RBC Transfusion With Unwashed RBC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/41 (17.07%)      6/59 (10.17%)    
Cardiac disorders     
MI   5/41 (12.20%)  5 4/59 (6.78%)  4
Renal and urinary disorders     
Renal Failure   1/41 (2.44%)  1 2/59 (3.39%)  2
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure   1/41 (2.44%)  1 2/59 (3.39%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transfusion With Washed RBC Transfusion With Unwashed RBC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/41 (51.22%)      44/59 (74.58%)    
Blood and lymphatic system disorders     
Thrombosis   1/41 (2.44%)  1 1/59 (1.69%)  1
Infections and infestations     
Infection   3/41 (7.32%)  3 4/59 (6.78%)  4
Fever   1/41 (2.44%)  1 0/59 (0.00%)  0
Nervous system disorders     
Neurologic AE   7/41 (17.07%)  7 10/59 (16.95%)  10
Renal and urinary disorders     
Renal   1/41 (2.44%)  1 7/59 (11.86%)  7
Respiratory, thoracic and mediastinal disorders     
Respiratory   9/41 (21.95%)  9 18/59 (30.51%)  18
Vascular disorders     
CVD   16/41 (39.02%)  16 31/59 (52.54%)  31
Indicates events were collected by systematic assessment
A major limitation of the present study is its small sample size and its restriction to CABG surgery. Larger-scale controlled studies comparing transfusion with washed vs. unwashed PCs are warranted.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Wenche Jy, PhD, Research Associate Professor, Principal Investigator
Organization: University of Miami
Phone: 305-243-6617
Responsible Party: Wenche Jy, University of Miami
ClinicalTrials.gov Identifier: NCT01185600     History of Changes
Other Study ID Numbers: 20090685
R01HL098031 ( U.S. NIH Grant/Contract )
First Submitted: August 17, 2010
First Posted: August 20, 2010
Results First Submitted: July 18, 2016
Results First Posted: November 23, 2016
Last Update Posted: July 2, 2017