Trial Outcomes & Findings for Tranexamic Acid in Radical Resection and Endoprosthetic Reconstruction (NCT NCT04347122)
NCT ID: NCT04347122
Last Updated: 2025-05-21
Results Overview
How much blood was lost during surgical process
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
During surgical procedure, 4 to 6 hours
Results posted on
2025-05-21
Participant Flow
Participant milestones
| Measure |
Bony Tumor w/ TXA Group
bony tumor that will receive TXA
|
Bony Tumor no TXA Group
bony tumor with no TXA treatment
|
Soft Tissue Tumor w/ TXA Group
soft tissue tumor that will receive TXA
|
Soft Tissue Tumor With no TXA Group
soft tissue tumor with no TXA
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
3
|
6
|
Reasons for withdrawal
| Measure |
Bony Tumor w/ TXA Group
bony tumor that will receive TXA
|
Bony Tumor no TXA Group
bony tumor with no TXA treatment
|
Soft Tissue Tumor w/ TXA Group
soft tissue tumor that will receive TXA
|
Soft Tissue Tumor With no TXA Group
soft tissue tumor with no TXA
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
3
|
3
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bony Tumor Treated With Tranexamic Acid (TXA)
This group of participants will undergo a bony tumor resection of the femur or proximal tibia and endoprosthetic reconstruction with TXA.
Tranexamic Acid (TXA): Intervention groups will receive TXA 1g TXA IVPB 10 minutes prior to incision and a second dose of 1g IVPB at the time of closure.
|
Bony Tumor Treated Without TXA
n=3 Participants
This group of participants will undergo a bony tumor resection of the femur of proximal tibia and endoprosthetic reconstruction.
|
Soft Tissue Sarcoma Treated With Tranexamic Acid (TXA)
n=3 Participants
This group of participants will undergo soft tissue sarcoma resection of the lower extremity with TXA
Tranexamic Acid (TXA): Intervention groups will receive TXA 1g TXA IVPB 10 minutes prior to incision and a second dose of 1g IVPB at the time of closure.
|
Soft Tissue Sarcoma Treated Without TXA
n=6 Participants
This group of participants will undergo soft tissue sarcoma resection of the lower extremity.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
12 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
7 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: During surgical procedure, 4 to 6 hoursPopulation: Bony tumor w/ TXA group had no participants
How much blood was lost during surgical process
Outcome measures
| Measure |
Bony Tumor w/ TXA Group
bony tumor that will receive TXA
|
Bony Tumor no TXA Group
n=3 Participants
bony tumor with no TXA treatment
|
Soft Tissue Tumor w/ TXA Group
n=3 Participants
soft tissue tumor that will receive TXA
|
Soft Tissue Tumor With no TXA Group
n=6 Participants
soft tissue tumor with no TXA
|
|---|---|---|---|---|
|
Perioperative Blood Loss
|
—
|
283 mL
Interval 250.0 to 350.0
|
700 mL
Interval 100.0 to 1800.0
|
416 mL
Interval 100.0 to 700.0
|
Adverse Events
Bony Tumor w/ TXA Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bony Tumor no TXA Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Soft Tissue Tumor w/ TXA Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Soft Tissue Tumor With no TXA 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