Trial Outcomes & Findings for Efficacy of Tranexamic Acid for Reducing Blood Loss and Blood Transfusion After Periacetabular Osteotomy (NCT NCT02253810)
NCT ID: NCT02253810
Last Updated: 2022-11-25
Results Overview
Calculated total blood loss by patients
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
1day (Hospital Admission)
Results posted on
2022-11-25
Participant Flow
Participant milestones
| Measure |
Tranexamic Acid
Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.
Tranexamic Acid
|
Placebo
Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
44
|
|
Overall Study
COMPLETED
|
40
|
41
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Tranexamic Acid
Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.
Tranexamic Acid
|
Placebo
Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.
Placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Unknown concomitant procedure
|
3
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tranexamic Acid
n=40 Participants
Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.
Tranexamic Acid
|
Placebo
n=41 Participants
Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.
Placebo
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=40 Participants
|
6 Participants
n=41 Participants
|
16 Participants
n=81 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=40 Participants
|
35 Participants
n=41 Participants
|
65 Participants
n=81 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=81 Participants
|
|
Age, Continuous
|
25.1 years
STANDARD_DEVIATION 7.2 • n=40 Participants
|
26.8 years
STANDARD_DEVIATION 7.7 • n=41 Participants
|
25.9 years
STANDARD_DEVIATION 7.4 • n=81 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=40 Participants
|
40 Participants
n=41 Participants
|
78 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=40 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=81 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
40 participants
n=40 Participants
|
41 participants
n=41 Participants
|
81 participants
n=81 Participants
|
PRIMARY outcome
Timeframe: 1day (Hospital Admission)Calculated total blood loss by patients
Outcome measures
| Measure |
Tranexamic Acid
n=40 Participants
Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.
Tranexamic Acid
|
Placebo
n=41 Participants
Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.
Placebo
|
|---|---|---|
|
Calculated Total Blood Loss
|
1264.6 mL
Interval 483.6 to 2046.9
|
1515.4 mL
Interval 724.7 to 2582.2
|
SECONDARY outcome
Timeframe: 1day (Hospital Admission)Total allogenic blood transfusion
Outcome measures
| Measure |
Tranexamic Acid
n=40 Participants
Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively.
Tranexamic Acid
|
Placebo
n=41 Participants
Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively.
Placebo
|
|---|---|---|
|
Number of Patients With Allogenic Blood Transfusion
|
4 participants
|
15 participants
|
Adverse Events
Tranexamic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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