Trial Outcomes & Findings for TXA in Revision Total Shoulder Arthroplasty (NCT NCT04650698)
NCT ID: NCT04650698
Last Updated: 2024-03-12
Results Overview
The volume of perioperative blood loss will be determined on the basis of the blood volume and change in hemoglobin from preoperatively to 1 day postoperatively. The volume of total perioperative blood loss will be determined according to the following formula: Total blood loss (ml) = 1000 x 〖Hb〗\_loss/〖Hb〗\_i
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
up to 24 hours post-op
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
Tranexamic Acid (TXA) Injection
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.
Tranexamic acid (TXA) injection: IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)
|
Control - No Tranexamic Acid (TXA) Injection
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
7
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Tranexamic Acid (TXA) Injection
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.
Tranexamic acid (TXA) injection: IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)
|
Control - No Tranexamic Acid (TXA) Injection
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
TXA in Revision Total Shoulder Arthroplasty
Baseline characteristics by cohort
| Measure |
Tranexamic Acid (TXA) Injection
n=10 Participants
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.
Tranexamic acid (TXA) injection: IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)
|
Control - No Tranexamic Acid (TXA) Injection
n=5 Participants
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 6.685 • n=5 Participants
|
62 years
STANDARD_DEVIATION 8.98 • n=7 Participants
|
63 years
STANDARD_DEVIATION 8.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 hours post-opThe volume of perioperative blood loss will be determined on the basis of the blood volume and change in hemoglobin from preoperatively to 1 day postoperatively. The volume of total perioperative blood loss will be determined according to the following formula: Total blood loss (ml) = 1000 x 〖Hb〗\_loss/〖Hb〗\_i
Outcome measures
| Measure |
Tranexamic Acid (TXA) Injection
n=10 Participants
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.
Tranexamic acid (TXA) injection: IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)
|
Control - No Tranexamic Acid (TXA) Injection
n=5 Participants
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA.
|
|---|---|---|
|
Total Calculated Total Blood Loss
|
0.5952 Milliliters
Standard Deviation 0.3312
|
0.8306 Milliliters
Standard Deviation 0.3641
|
PRIMARY outcome
Timeframe: up to 24 hours post-opThe floor nurse will also document the amount of blood in the indwelling hemovac surgical drain placed in the operative shoulder joint up to 24 hours. The total surgical drain output will be calculated after 24 hours.
Outcome measures
| Measure |
Tranexamic Acid (TXA) Injection
n=10 Participants
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.
Tranexamic acid (TXA) injection: IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)
|
Control - No Tranexamic Acid (TXA) Injection
n=5 Participants
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA.
|
|---|---|---|
|
Total Surgical Drain Output
|
101.5 Milliliters
Standard Deviation 88.43
|
153 Milliliters
Standard Deviation 129
|
SECONDARY outcome
Timeframe: 2 weeks post-opSurgeon will assess for presence of hematoma at the 2-week follow up visit.
Outcome measures
| Measure |
Tranexamic Acid (TXA) Injection
n=10 Participants
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.
Tranexamic acid (TXA) injection: IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)
|
Control - No Tranexamic Acid (TXA) Injection
n=5 Participants
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA.
|
|---|---|---|
|
Number of Participants With Presence of Hematoma
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks post-opOutcome measures
| Measure |
Tranexamic Acid (TXA) Injection
n=10 Participants
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.
Tranexamic acid (TXA) injection: IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)
|
Control - No Tranexamic Acid (TXA) Injection
n=5 Participants
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA.
|
|---|---|---|
|
Number of Participants Who Needed a Post-op Blood Transfusion
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During operation, up to 4 hoursOutcome measures
| Measure |
Tranexamic Acid (TXA) Injection
n=10 Participants
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.
Tranexamic acid (TXA) injection: IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)
|
Control - No Tranexamic Acid (TXA) Injection
n=5 Participants
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA.
|
|---|---|---|
|
Average Operative Time
|
104.6 minutes
Standard Deviation 26.12
|
130.4 minutes
Standard Deviation 37.58
|
Adverse Events
Tranexamic Acid (TXA) Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - No Tranexamic Acid (TXA) Injection
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