Trial Outcomes & Findings for Mirasol-Treated Platelets - (Pathogen Reduction Extended Storage Study) (NCT NCT01368211)
NCT ID: NCT01368211
Last Updated: 2016-06-28
Results Overview
Thromboelastography (TEG) Parameter: Pre- to post-transfusional modification of Maximum Amplitude at 1-hour post-transfusion
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
16 participants
Primary outcome timeframe
pre-transfusion, 1-hour post transfusion
Results posted on
2016-06-28
Participant Flow
16 patients enrolled versus 15 patients started: One patient was enrolled by error (exclusion criteria) and excluded after randomization.
Participant milestones
| Measure |
Mirasol First, Then Reference
This study arm received first a Mirasol treated 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).
Mirasol-treated Platelets: Mirasol-treated platelet units with:
* Platelet yield between 2.4x10e11 and 4.5x10e11
* Plasma carryover of \>32%
* Cell count \> 800x103/µL
|
Reference First, Then Mirasol
This study arm received first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).
Mirasol-treated Platelets: Mirasol-treated platelet units with:
* Platelet yield between 2.4x10e11 and 4.5x10e11
* Plasma carryover of \>32%
* Cell count \> 800x103/µL
|
|---|---|---|
|
First Platelets Transfusion
STARTED
|
8
|
7
|
|
First Platelets Transfusion
COMPLETED
|
8
|
7
|
|
First Platelets Transfusion
NOT COMPLETED
|
0
|
0
|
|
Second Platelets Transfusion
STARTED
|
8
|
7
|
|
Second Platelets Transfusion
COMPLETED
|
7
|
5
|
|
Second Platelets Transfusion
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Mirasol First, Then Reference
This study arm received first a Mirasol treated 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).
Mirasol-treated Platelets: Mirasol-treated platelet units with:
* Platelet yield between 2.4x10e11 and 4.5x10e11
* Plasma carryover of \>32%
* Cell count \> 800x103/µL
|
Reference First, Then Mirasol
This study arm received first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).
Mirasol-treated Platelets: Mirasol-treated platelet units with:
* Platelet yield between 2.4x10e11 and 4.5x10e11
* Plasma carryover of \>32%
* Cell count \> 800x103/µL
|
|---|---|---|
|
Second Platelets Transfusion
No need for additional transfusion
|
1
|
2
|
Baseline Characteristics
Mirasol-Treated Platelets - (Pathogen Reduction Extended Storage Study)
Baseline characteristics by cohort
| Measure |
Mirasol First, Then Reference
n=8 Participants
This study arm will receive first a Mirasol treated 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).
Mirasol-treated Platelets: Mirasol-treated platelet units with:
* Platelet yield between 2.4x10e11 and 4.5x10e11
* Plasma carryover of \>32%
* Cell count \> 800x103/µL
|
Reference First, Then Mirasol
n=7 Participants
This study arm will receive first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).
Mirasol-treated Platelets: Mirasol-treated platelet units with:
* Platelet yield between 2.4x10e11 and 4.5x10e11
* Plasma carryover of \>32%
* Cell count \> 800x103/µL
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.13 Years
STANDARD_DEVIATION 12.76 • n=5 Participants
|
55.29 Years
STANDARD_DEVIATION 19.95 • n=7 Participants
|
57.33 Years
STANDARD_DEVIATION 15.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: pre-transfusion, 1-hour post transfusionThromboelastography (TEG) Parameter: Pre- to post-transfusional modification of Maximum Amplitude at 1-hour post-transfusion
Outcome measures
| Measure |
Mirasol
n=9 Participants
Mirasol-treated 2-4-day old platelet transfusion
|
Untreated Reference
n=9 Participants
Untreated 2-4-day old platelet transfusion
|
|---|---|---|
|
Change in Maximum Amplitude at 1-hour Post-transfusion
|
9.4 mm
Standard Deviation 7.0
|
15.4 mm
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: pre-transfusion, 24-hour post transfusionThromboelastography parameter: Pre- to post-transfusional modification in Maximum Amplitude at 24-hours post-transfusion
Outcome measures
| Measure |
Mirasol
n=9 Participants
Mirasol-treated 2-4-day old platelet transfusion
|
Untreated Reference
n=9 Participants
Untreated 2-4-day old platelet transfusion
|
|---|---|---|
|
Change in Maximum Amplitude at 24-hours Post-transfusion
|
10.4 mm
Standard Deviation 8.0
|
8.4 mm
Standard Deviation 4.7
|
Adverse Events
Mirasol-treated Platelets
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Untreated Reference Platelets
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
Dr. Pär Johansson
Transfusion Service Rigshospitalet - Dept of Immunology, Copenhagen Denmark
Phone: +45 35452030
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60