Trial Outcomes & Findings for In Vitro Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution (NCT NCT02298842)
NCT ID: NCT02298842
Last Updated: 2017-07-21
Results Overview
The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH \>6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
Day 5
Results posted on
2017-07-21
Participant Flow
87 volunteers signed consent and were enrolled in the study, but 2 were screen fails and therefore did not participate in the study
Participant milestones
| Measure |
InterSol First, Then Plasma
Platelets collected in InterSol, then platelets collected in plasma
|
Plasma First, Then InterSol
Platelets collected in plasma, then platelets collected in InterSol
|
|---|---|---|
|
First Platelet Donation (Day 0)
STARTED
|
44
|
41
|
|
First Platelet Donation (Day 0)
COMPLETED
|
38
|
36
|
|
First Platelet Donation (Day 0)
NOT COMPLETED
|
6
|
5
|
|
Second Platelet Donation (Day 6-8)
STARTED
|
38
|
36
|
|
Second Platelet Donation (Day 6-8)
COMPLETED
|
30
|
30
|
|
Second Platelet Donation (Day 6-8)
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In Vitro Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution
Baseline characteristics by cohort
| Measure |
InterSol First, Then Plasma
n=44 Participants
Platelets collected in InterSol, then platelets collected in plasma
|
Plasma First, Then InterSol
n=41 Participants
Platelets collected in plasma, then platelets collected in InterSol
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 14.10 • n=99 Participants
|
43.3 years
STANDARD_DEVIATION 14.98 • n=107 Participants
|
42.1 years
STANDARD_DEVIATION 14.49 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=99 Participants
|
41 participants
n=107 Participants
|
85 participants
n=206 Participants
|
|
Height
|
69.5 inches
STANDARD_DEVIATION 3.12 • n=99 Participants
|
68.5 inches
STANDARD_DEVIATION 3.43 • n=107 Participants
|
69.0 inches
STANDARD_DEVIATION 3.30 • n=206 Participants
|
|
Weight
|
197.9 lbs
STANDARD_DEVIATION 34.38 • n=99 Participants
|
188.7 lbs
STANDARD_DEVIATION 30.87 • n=107 Participants
|
193.4 lbs
STANDARD_DEVIATION 32.87 • n=206 Participants
|
|
Total Blood Volume (TBV)
|
5380.1 mL
STANDARD_DEVIATION 770.93 • n=99 Participants
|
5172.5 mL
STANDARD_DEVIATION 757.45 • n=107 Participants
|
5280.0 mL
STANDARD_DEVIATION 767.04 • n=206 Participants
|
PRIMARY outcome
Timeframe: Day 5Population: The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.
The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH \>6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.
Outcome measures
| Measure |
Test Platelets Collected and Stored in InterSol
n=60 Participants
Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
Control Platelets Collected and Stored in Plasma
n=60 Participants
Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
|---|---|---|
|
pH of Platelets at Day 5
|
7.184 pH
Standard Deviation 0.0718
|
7.414 pH
Standard Deviation 0.0975
|
PRIMARY outcome
Timeframe: Day 7Population: The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.
The primary endpoint for this study is pH of platelets stored in InterSol at Day 7. The FDA acceptance criteria for pH is 95% of products have pH \>6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.
Outcome measures
| Measure |
Test Platelets Collected and Stored in InterSol
n=60 Participants
Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
Control Platelets Collected and Stored in Plasma
n=60 Participants
Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
|---|---|---|
|
pH of Platelets at Day 7
|
7.152 pH
Standard Deviation 0.0855
|
7.335 pH
Standard Deviation 0.1313
|
SECONDARY outcome
Timeframe: Day 5Population: The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.
Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.
Outcome measures
| Measure |
Test Platelets Collected and Stored in InterSol
n=60 Participants
Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
Control Platelets Collected and Stored in Plasma
n=60 Participants
Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
|---|---|---|
|
Percent of Platelets Activated as Measured by P-selectin
|
26.324 Percent of Platelets Activated
Standard Deviation 7.6052
|
9.354 Percent of Platelets Activated
Standard Deviation 4.4110
|
SECONDARY outcome
Timeframe: Day 5Population: The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.
Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality.
Outcome measures
| Measure |
Test Platelets Collected and Stored in InterSol
n=60 Participants
Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
Control Platelets Collected and Stored in Plasma
n=60 Participants
Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
|---|---|---|
|
Percent of Extent of Shape Change
|
24.109 % extent of shape change
Standard Deviation 5.9968
|
30.658 % extent of shape change
Standard Deviation 5.1498
|
SECONDARY outcome
Timeframe: Day 5Population: The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.
Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.
Outcome measures
| Measure |
Test Platelets Collected and Stored in InterSol
n=60 Participants
Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
Control Platelets Collected and Stored in Plasma
n=60 Participants
Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
|---|---|---|
|
Percent of Platelets Exhibiting Hypotonic Shock Response
|
44.507 % of hypotonic shock response
Standard Deviation 8.4013
|
56.467 % of hypotonic shock response
Standard Deviation 9.6924
|
SECONDARY outcome
Timeframe: Day 5Population: The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.
Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.
Outcome measures
| Measure |
Test Platelets Collected and Stored in InterSol
n=60 Participants
Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
Control Platelets Collected and Stored in Plasma
n=60 Participants
Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
|---|---|---|
|
Platelet Morphology
|
293.1 scores on a scale
Standard Deviation 31.76
|
308.7 scores on a scale
Standard Deviation 33.30
|
SECONDARY outcome
Timeframe: Day 7Population: The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.
Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.
Outcome measures
| Measure |
Test Platelets Collected and Stored in InterSol
n=60 Participants
Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
Control Platelets Collected and Stored in Plasma
n=60 Participants
Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
|---|---|---|
|
Percent of Platelets Activated as Measured by P-selectin
|
29.392 Percent of Platelets Activated
Standard Deviation 8.0418
|
14.232 Percent of Platelets Activated
Standard Deviation 6.4316
|
SECONDARY outcome
Timeframe: Day 7Population: The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.
Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality. Higher value is considered to indicate better platelet quality.
Outcome measures
| Measure |
Test Platelets Collected and Stored in InterSol
n=60 Participants
Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
Control Platelets Collected and Stored in Plasma
n=60 Participants
Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
|---|---|---|
|
Percent of Extent of Shape Change
|
19.328 % of extent of shape change
Standard Deviation 6.1433
|
27.962 % of extent of shape change
Standard Deviation 5.4495
|
SECONDARY outcome
Timeframe: Day 7Population: The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.
Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.
Outcome measures
| Measure |
Test Platelets Collected and Stored in InterSol
n=60 Participants
Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
Control Platelets Collected and Stored in Plasma
n=60 Participants
Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
|---|---|---|
|
Percent of Platelets Exhibiting Hypotonic Shock Response
|
37.038 % of hypotonic shock response
Standard Deviation 7.4719
|
49.284 % of hypotonic shock response
Standard Deviation 11.4719
|
SECONDARY outcome
Timeframe: Day 7Population: The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.
Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.
Outcome measures
| Measure |
Test Platelets Collected and Stored in InterSol
n=60 Participants
Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
Control Platelets Collected and Stored in Plasma
n=60 Participants
Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
|---|---|---|
|
Platelet Morphology
|
269.7 score on a scale
Standard Deviation 31.26
|
282.5 score on a scale
Standard Deviation 34.79
|
Adverse Events
Test Platelets Collected and Stored in InterSol
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Control Platelets Collected and Stored in Plasma
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Platelets Collected and Stored in InterSol
n=82 participants at risk
Platelets stored in InterSol
Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
Control Platelets Collected and Stored in Plasma
n=77 participants at risk
Platelets stored in Plasma
Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
|
|---|---|---|
|
General disorders
Injection site extravasation
|
8.5%
7/82 • Number of events 7 • Treatment emergent adverse events were reported for any participant that underwent any study related apheresis procedure. Only adverse events that occured during the apheresis procedure and until discharge were reported.
|
0.00%
0/77 • Treatment emergent adverse events were reported for any participant that underwent any study related apheresis procedure. Only adverse events that occured during the apheresis procedure and until discharge were reported.
|
|
Nervous system disorders
Paraesthesia oral
|
2.4%
2/82 • Number of events 2 • Treatment emergent adverse events were reported for any participant that underwent any study related apheresis procedure. Only adverse events that occured during the apheresis procedure and until discharge were reported.
|
1.3%
1/77 • Number of events 1 • Treatment emergent adverse events were reported for any participant that underwent any study related apheresis procedure. Only adverse events that occured during the apheresis procedure and until discharge were reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/82 • Treatment emergent adverse events were reported for any participant that underwent any study related apheresis procedure. Only adverse events that occured during the apheresis procedure and until discharge were reported.
|
1.3%
1/77 • Number of events 1 • Treatment emergent adverse events were reported for any participant that underwent any study related apheresis procedure. Only adverse events that occured during the apheresis procedure and until discharge were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor retains the right to review and comment on any public disclosure of study results. If no response is received within 30 days,the Principal Investigator may presume that the submission for publication may proceed without delay. If the Sponsor asks to defer publication, Study Site shall not publish, or otherwise disclose to any third party, any of the information contained in the publication or presentation until such time as permission is granted from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER