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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Transfusion With Washed RBC   Transfusion With Unwashed RBC
STARTED   73   104 
COMPLETED   41   59 
NOT COMPLETED   32   45 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Transfusion With Washed RBC   Transfusion With Unwashed RBC   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   59   100 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 61.7  (7.1)   63.9  (11.1)   63.0  (9.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  24.4%      21  35.6%      31  31.0% 
Male      31  75.6%      38  64.4%      69  69.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   41   59   100 
CD41+ platelet microparticles [1] 
[Units: Counts / uL]
Mean (Standard Deviation)
 11858  (10066)   12118  (10517)   12009  (10279) 
[1] Cd41+ platelet microparticles is a specific biomarker for platelet activation
CD235a+ red cell microparticles [1] 
[Units: Counts / uL]
Mean (Standard Deviation)
 2017  (2414)   1862  (1719)   1927  (2029) 
[1] 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] 
[Units: Counts / uL]
Mean (Standard Deviation)
 297  (430)   296  (446)   296  (435) 
[1] CD62E+ endothelial microparticles are a specific marker for endothelial activation and apoptosis.
Annexin V+ microparticles [1] 
[Units: Counts / uL]
Mean (Standard Deviation)
 9171  (10710)   6637  (6518)   7697  (8568) 
[1] Annexin V+ microparticles are a marker for non-specific cell activation and apoptosis.


  Outcome Measures

1.  Primary:   In Hospital Mortality   [ Time Frame: Within 30 days after CABG surgery ]

2.  Primary:   One-year Mortality   [ Time Frame: Within one year after CABG surgery ]

3.  Primary:   Occurrence of at Least One Serious Adverse Event (SAE)   [ Time Frame: within 30 days after CABG surgery ]

4.  Primary:   Difference in Levels of Circulating CD41+ Platelet-derived Microparticles 1 Hour Post-surgery   [ Time Frame: interval between presurgery and 1 hour post-surgery ]

5.  Primary:   Difference in Levels of Circulating Annexin V+ Microparticles 1 Hour Post- Surgery   [ Time Frame: Interval between pre-surgery and 1 hour post-surgery ]

6.  Primary:   Difference in Levels of Circulating CD62E+ Endothelial Microparticles 1 Hour Post-surgery   [ Time Frame: Interval between pre-surgery and 1 hour post-surgery ]

7.  Primary:   Difference in Levels of Circulating CD235a+ Red Cell Microparticles 1 Hour Post-surgery   [ Time Frame: Interval between pre-surgery and 1 hour post-surgery ]

8.  Secondary:   Each Participant's Number of Non-serious Adverse Events   [ Time Frame: Within 30 days after CABG surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: wjy@med.miami.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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