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Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions

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ClinicalTrials.gov Identifier: NCT02731157
Recruitment Status : Completed
First Posted : April 7, 2016
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Other
Condition Sickle Cell Disease
Interventions Drug: Rejuvesol
Procedure: Blood transfusion
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description Each participant in this 4 subject pilot study acted as their own control. Red cell exchanges (RCEs) occurred approximately every month and, over a 6 month period, the sequence of exchanges for each patient was: SRRRSS, where S=standard and R=rejuvenated RCEs.
Period Title: First Standard RCE
Started 4
Completed 4
Not Completed 0
Period Title: First Rejuvenated RCE
Started 4
Completed 3
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Period Title: Second Rejuvenated RCE
Started 3
Completed 3
Not Completed 0
Period Title: Third Rejuvenated RCE
Started 3
Completed 3
Not Completed 0
Period Title: Second Standard RCE
Started 3
Completed 3
Not Completed 0
Period Title: Third Standard RCE
Started 3
Completed 3
Not Completed 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Each participant in this 4 subject pilot study acted as their own control. Red cell exchanges (RCEs) occurred approximately every month and, over a 6 month period, the sequence of exchanges for each patient was: SRRRSS, where S=standard and R=rejuvenated RCEs.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
4
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
 100.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
 100.0%
1.Primary Outcome
Title Average Percent Hemoglobin (HbA) Decrement Per Day
Hide Description The %HbA decrement is the current pre-treatment HbA - previous post treatment HbA in %. The average %HbA decrement per day was calculated using matched pairs.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Each participant acted as their own control with a sequence of rejuvenated and standard exchanges over 6 months. One subject ended further study participation after only 1 rejuvenated RBC exchange; limited data available.
Arm/Group Title Transfusion With Rejuvenated Red Blood Cells (RBCs) Transfusion With Standard Red Blood Cells
Hide Arm/Group Description:

Subjects with sickle cell disease will receive RBCs treated with Rejuvesol®. Scheduled red cell exchanges performed with the last 4 units of the exchange having been incubated with Rejuvesol® solution. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Rejuvesol

Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Subjects with sickle cell disease will receive standard RBCs. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Overall Number of Participants Analyzed 4 4
Mean (Full Range)
Unit of Measure: %HbA per day
0.629
(0.261 to 0.846)
0.659
(0.261 to 0.846)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transfusion With Rejuvenated Red Blood Cells (RBCs), Transfusion With Standard Red Blood Cells
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.65
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Actual HbA Decrement (g/dl) With Indexing to Calculated Circulating Blood Volume
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Transfusion With Rejuvenated Red Blood Cells (RBCs) Transfusion With Standard Red Blood Cells
Hide Arm/Group Description:

Subjects with sickle cell disease will receive RBCs treated with Rejuvesol®. Scheduled red cell exchanges performed with the last 4 units of the exchange having been incubated with Rejuvesol® solution. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Rejuvesol

Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Subjects with sickle cell disease will receive standard RBCs. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Actual HbA Decrement (g/dl) Without Indexing to Calculated Circulating Blood Volume
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Transfusion With Rejuvenated Red Blood Cells (RBCs) Transfusion With Standard Red Blood Cells
Hide Arm/Group Description:

Subjects with sickle cell disease will receive RBCs treated with Rejuvesol®. Scheduled red cell exchanges performed with the last 4 units of the exchange having been incubated with Rejuvesol® solution. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Rejuvesol

Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Subjects with sickle cell disease will receive standard RBCs. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in RBC Microparticles (MP) Counts
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Transfusion With Rejuvenated Red Blood Cells (RBCs) Transfusion With Standard Red Blood Cells
Hide Arm/Group Description:

Subjects with sickle cell disease will receive RBCs treated with Rejuvesol®. Scheduled red cell exchanges performed with the last 4 units of the exchange having been incubated with Rejuvesol® solution. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Rejuvesol

Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Subjects with sickle cell disease will receive standard RBCs. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in RBC/RBC-MP-mediated Thrombin Generation
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Transfusion With Rejuvenated Red Blood Cells (RBCs) Transfusion With Standard Red Blood Cells
Hide Arm/Group Description:

Subjects with sickle cell disease will receive RBCs treated with Rejuvesol®. Scheduled red cell exchanges performed with the last 4 units of the exchange having been incubated with Rejuvesol® solution. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Rejuvesol

Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Subjects with sickle cell disease will receive standard RBCs. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in p50 Pre- and Post-transfusion
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Transfusion With Rejuvenated Red Blood Cells (RBCs) Transfusion With Standard Red Blood Cells
Hide Arm/Group Description:

Subjects with sickle cell disease will receive RBCs treated with Rejuvesol®. Scheduled red cell exchanges performed with the last 4 units of the exchange having been incubated with Rejuvesol® solution. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Rejuvesol

Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Subjects with sickle cell disease will receive standard RBCs. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Blood transfusion: Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transfusion With Standard RBCs Transfusion With Rejuvenated RBCs
Hide Arm/Group Description Each participant received three standard red cell exchanges. Each participant received three rejuvenated red cell exchanges.
All-Cause Mortality
Transfusion With Standard RBCs Transfusion With Rejuvenated RBCs
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
Transfusion With Standard RBCs Transfusion With Rejuvenated RBCs
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transfusion With Standard RBCs Transfusion With Rejuvenated RBCs
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ian Welsby, M.D.
Organization: Duke University
Phone: 919-681-6752
EMail: ian.welsby@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02731157    
Other Study ID Numbers: Pro00069955
First Submitted: April 2, 2016
First Posted: April 7, 2016
Results First Submitted: November 9, 2018
Results First Posted: January 25, 2019
Last Update Posted: January 25, 2019