Trial Outcomes & Findings for Clinical Evaluation of the OrthoPAT Advance System (NCT NCT01756976)
NCT ID: NCT01756976
Last Updated: 2013-11-20
Results Overview
The Hematocrit of the RBC shall be \> 50%.
Recruitment status
COMPLETED
Target enrollment
84 participants
Primary outcome timeframe
< 4 hours
Results posted on
2013-11-20
Participant Flow
Participant milestones
| Measure |
Investigational Device
The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
|
Control Group
The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
8
|
|
Overall Study
COMPLETED
|
73
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Evaluation of the OrthoPAT Advance System
Baseline characteristics by cohort
| Measure |
Investigational Device
n=76 Participants
The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
|
Control Group
n=8 Participants
The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Age Continuous
|
56 years
STANDARD_DEVIATION 19 • n=93 Participants
|
46 years
STANDARD_DEVIATION 9 • n=4 Participants
|
55 years
STANDARD_DEVIATION 19 • n=27 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=93 Participants
|
8 participants
n=4 Participants
|
84 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: < 4 hoursThe Hematocrit of the RBC shall be \> 50%.
Outcome measures
| Measure |
Investigational Device
n=15 Participants
The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
|
Control Group
n=6 Participants
The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
|
|---|---|---|
|
Washed RBC Hematocrit
|
55.43 percentage of HcT
Standard Deviation 7.47
|
56.48 percentage of HcT
Standard Deviation 5.28
|
Adverse Events
Investigational Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60