Trial Outcomes & Findings for TXA in Anticoagulated Patients Study (NCT NCT04560010)
NCT ID: NCT04560010
Last Updated: 2024-03-26
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
17 participants
Primary outcome timeframe
Baseline to 24 hours post op
Results posted on
2024-03-26
Participant Flow
Participant milestones
| Measure |
Tranexamic Acid Injection (TXA)
Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.
Tranexamic Acid Injection (TXA): Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
|
No Tranexamic Acid Injection (TXA) Given
Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TXA in Anticoagulated Patients Study
Baseline characteristics by cohort
| Measure |
Tranexamic Acid Injection (TXA)
n=8 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.
Tranexamic Acid Injection (TXA): Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
|
No Tranexamic Acid Injection (TXA) Given
n=9 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 7.71 • n=5 Participants
|
72 years
STANDARD_DEVIATION 6.944 • n=7 Participants
|
72 years
STANDARD_DEVIATION 7.511 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 hours post op"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"
Outcome measures
| Measure |
Tranexamic Acid Injection (TXA)
n=8 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.
Tranexamic Acid Injection (TXA): Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
|
No Tranexamic Acid Injection (TXA) Given
n=9 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA.
|
|---|---|---|
|
Calculated Total Blood Loss
|
0.6632 Milliliters
Standard Deviation 0.2569
|
0.602 Milliliters
Standard Deviation 0.2228
|
PRIMARY outcome
Timeframe: Up to 24 hours post-opSurgical drain output will be recorded by floor nurse every 8 hours in EPIC. Data will be recorded up to 24 hours post-op if needed.
Outcome measures
| Measure |
Tranexamic Acid Injection (TXA)
n=8 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.
Tranexamic Acid Injection (TXA): Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
|
No Tranexamic Acid Injection (TXA) Given
n=9 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA.
|
|---|---|---|
|
Total Surgical Drain Output
|
131.3 Milliliters
Standard Deviation 71.81
|
146.7 Milliliters
Standard Deviation 75.7
|
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 Injection (TXA)
n=8 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.
Tranexamic Acid Injection (TXA): Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
|
No Tranexamic Acid Injection (TXA) Given
n=9 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA.
|
|---|---|---|
|
Number of Participants With Presence of Hematoma
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 hours post-opOutcome measures
| Measure |
Tranexamic Acid Injection (TXA)
n=8 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.
Tranexamic Acid Injection (TXA): Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
|
No Tranexamic Acid Injection (TXA) Given
n=9 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive no 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 Injection (TXA)
n=8 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.
Tranexamic Acid Injection (TXA): Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
|
No Tranexamic Acid Injection (TXA) Given
n=9 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA.
|
|---|---|---|
|
Average Operative Time
|
88.25 minutes
Standard Deviation 24.85
|
96 minutes
Standard Deviation 19.33
|
SECONDARY outcome
Timeframe: Up until 30 days after last day of study participation, an average of 6 weeksOutcome measures
| Measure |
Tranexamic Acid Injection (TXA)
n=8 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.
Tranexamic Acid Injection (TXA): Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
|
No Tranexamic Acid Injection (TXA) Given
n=9 Participants
Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA.
|
|---|---|---|
|
Number of Patients Who Developed Adverse Events Such as Myocardial Infarction (MI), Pulmonary Embolus (PE), and/or Deep Vein Thrombosis (DVT)
|
0 Participants
|
0 Participants
|
Adverse Events
Tranexamic Acid Injection (TXA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Tranexamic Acid Injection (TXA) Given
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