Trial Outcomes & Findings for A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains (NCT NCT02286102)
NCT ID: NCT02286102
Last Updated: 2019-10-29
Results Overview
The total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
48 hours postoperative
Results posted on
2019-10-29
Participant Flow
Participant milestones
| Measure |
Constavac
Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively
|
OrthoPAT
Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.
OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
COMPLETED
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Constavac
Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively
|
OrthoPAT
Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.
OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively
|
|---|---|---|
|
Overall Study
Screen Failure
|
1
|
1
|
Baseline Characteristics
A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains
Baseline characteristics by cohort
| Measure |
Constavac
n=35 Participants
Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively
|
OrthoPAT
n=33 Participants
Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.
OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively
|
Total
n=68 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
|
35 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 48 hours postoperativeThe total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place.
Outcome measures
| Measure |
Constavac
n=35 Participants
Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively
|
OrthoPAT
n=33 Participants
Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.
OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively
|
|---|---|---|
|
Volume of Allogenic Blood Transfused Postoperatively
|
458.33 mL
Standard Deviation 4.28
|
382.35 mL
Standard Deviation 62.22
|
SECONDARY outcome
Timeframe: 3 days postopHemoglobin levels will be measured post-operatively day 3
Outcome measures
| Measure |
Constavac
n=35 Participants
Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively
|
OrthoPAT
n=33 Participants
Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.
OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively
|
|---|---|---|
|
Hemoglobin Levels, Post-Op Day 3
|
9.07 g/Dl (grams/deciliter)
Standard Deviation .79
|
9.9 g/Dl (grams/deciliter)
Standard Deviation .99
|
SECONDARY outcome
Timeframe: 2 days postopHemoglobin levels will be measured post-operatively day 2
Outcome measures
| Measure |
Constavac
n=35 Participants
Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Constavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively
|
OrthoPAT
n=33 Participants
Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.
OrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively
|
|---|---|---|
|
Hemoglobin Levels, Post-Op Day 2
|
9.33 g/Dl (grams/deciliter)
Standard Deviation .88
|
10.19 g/Dl (grams/deciliter)
Standard Deviation 1.24
|
Adverse Events
OrthoPAT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Constavac
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