Trial Outcomes & Findings for Low Dose Peri- Operative Intra Venous Teranexamic Acid Reduces Blood Loss After Total Knee Arthroplasty: A Double Blind Randomized Placebo Controlled Clinical Trial (NCT NCT02327117)
NCT ID: NCT02327117
Last Updated: 2016-07-22
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
48 hours after TKA
Results posted on
2016-07-22
Participant Flow
Participant milestones
| Measure |
Tranexamic Acid
Tranexamic Acid
|
Normal Saline
Normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
45
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Dose Peri- Operative Intra Venous Teranexamic Acid Reduces Blood Loss After Total Knee Arthroplasty: A Double Blind Randomized Placebo Controlled Clinical Trial
Baseline characteristics by cohort
| Measure |
Tranexamic Acid
n=45 Participants
Tranexamic Acid
|
Normal Saline
n=45 Participants
Normal saline
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.04 year
STANDARD_DEVIATION 8.01 • n=5 Participants
|
65.66 year
STANDARD_DEVIATION 4.97 • n=7 Participants
|
66.35 year
STANDARD_DEVIATION 6.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hours after TKAOutcome measures
| Measure |
Tranexamic Acid
n=45 Participants
Tranexamic Acid
|
Normal Saline
n=45 Participants
Normal saline
|
|---|---|---|
|
Hb Level 48 Hours After Total Knee Arthroplasty
|
10.92 gr/dL
Standard Deviation 0.07
|
10.23 gr/dL
Standard Deviation 0.98
|
Adverse Events
Tranexamic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline
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