Trial Outcomes & Findings for Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty (NCT NCT01651806)
NCT ID: NCT01651806
Last Updated: 2017-12-13
Results Overview
Record intra-operative blood loss through drain output
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
65 participants
Primary outcome timeframe
Intra-operative, an average of 3 hours
Results posted on
2017-12-13
Participant Flow
Participant milestones
| Measure |
Female Uniform Single Dose TA Patient
Female patients receiving a single dose (1gram) of TA during TKA. Includes all female patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Uniform 1 gram dosing
|
Female Weighted Dose TA Patient
Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing
|
Control
Historical cohort of primary TKAs performed by BL, none of which received TA.
A control group was established from a historical cohort of primary TKAs performed by the senior author (BL), none of which received TA. The most relevant Pubmed ID would be 24997651.
|
Male Uniform Single Dose TA Patient
Male patients receiving a single dose (1gram) of TA during TKA. Includes all male patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Uniform 1 gram dosing
|
Male Weighted Dose TA Patient
Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
25
|
7
|
8
|
|
Overall Study
COMPLETED
|
13
|
12
|
25
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Female Patients Receiving a Uniform Dose of TA
n=13 Participants
Female Patients receiving a single dose of 1 gram of TA--includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.
Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.
|
Female Weighted Dose of TA Patients
n=12 Participants
Female Patients receiving a weighted dose of TA. Will include all patients that will get a weighted dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.
Tranexamic Acid weighted dose: Weighted dose--20mg/kg of the drug will be given
|
Control
n=25 Participants
Historical cohort of primary TKAs performed by senior author, none of which received TA.
|
Male Patients Receiving a Uniform Dose of TA
n=7 Participants
Male Patients receiving a single dose of 1 gram of TA--includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.
Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.
|
Male Weighted Dose of TA Patients
n=8 Participants
Male Patients receiving a weighted dose of TA. Will include all patients that will get a weighted dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.
Tranexamic Acid weighted dose: Weighted dose--20mg/kg of the drug will be given
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Age, Continuous
|
62.26 years
STANDARD_DEVIATION 7.31 • n=5 Participants
|
66.50 years
STANDARD_DEVIATION 9.65 • n=7 Participants
|
62.40 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
62.26 years
STANDARD_DEVIATION 7.31 • n=4 Participants
|
66.50 years
STANDARD_DEVIATION 9.65 • n=21 Participants
|
64.38 years
STANDARD_DEVIATION 8.84 • n=8 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
BMI
|
32.10 kg/m^2
STANDARD_DEVIATION 8.04 • n=5 Participants
|
35.40 kg/m^2
STANDARD_DEVIATION 8.50 • n=7 Participants
|
36 kg/m^2
STANDARD_DEVIATION 11.09 • n=5 Participants
|
32.10 kg/m^2
STANDARD_DEVIATION 8.04 • n=4 Participants
|
35.40 kg/m^2
STANDARD_DEVIATION 8.50 • n=21 Participants
|
33.75 kg/m^2
STANDARD_DEVIATION 8.436 • n=8 Participants
|
|
ASA
|
2.53 Scores on a Scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
2.26 Scores on a Scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
2.57 Scores on a Scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
2.53 Scores on a Scale
STANDARD_DEVIATION 0.6 • n=4 Participants
|
2.26 Scores on a Scale
STANDARD_DEVIATION 0.7 • n=21 Participants
|
2.395 Scores on a Scale
STANDARD_DEVIATION 0.67 • n=8 Participants
|
PRIMARY outcome
Timeframe: Intra-operative, an average of 3 hoursRecord intra-operative blood loss through drain output
Outcome measures
| Measure |
Female Uniform Single Dose TA Patient
n=13 Participants
Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Uniform 1 gram dosing
|
Female Weighted Dose TA Patient
n=12 Participants
Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing
|
Control
n=25 Participants
Historical cohort of primary TKAs performed by BL, none of which received TA.
|
Male Uniform Single Dose TA
n=7 Participants
Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Uniform 1 gram dosing
|
Male Weighted Dose TA Patient
n=8 Participants
Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing
|
|---|---|---|---|---|---|
|
Primary Intra-operative Blood Loss
|
100.00 mL
Standard Deviation 31.69
|
65.00 mL
Standard Deviation 8.50
|
142.80 mL
Standard Deviation 197
|
100.00 mL
Standard Deviation 31.69
|
65.00 mL
Standard Deviation 8.50
|
PRIMARY outcome
Timeframe: 1 yearDVT = Deep Venous thrombosis Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician.
Outcome measures
| Measure |
Female Uniform Single Dose TA Patient
n=13 Participants
Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Uniform 1 gram dosing
|
Female Weighted Dose TA Patient
n=12 Participants
Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing
|
Control
n=25 Participants
Historical cohort of primary TKAs performed by BL, none of which received TA.
|
Male Uniform Single Dose TA
n=7 Participants
Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Uniform 1 gram dosing
|
Male Weighted Dose TA Patient
n=8 Participants
Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing
|
|---|---|---|---|---|---|
|
Document Incidences of DVT and Other Thromboembolic Events.
|
1 Events
|
1 Events
|
0 Events
|
0 Events
|
0 Events
|
Adverse Events
Female Uniform Single Dose TA Patient
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Female Weighted Dose TA Patient
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Male Uniform Single Dose TA Patient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Male Weighted Dose TA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Female Uniform Single Dose TA Patient
n=13 participants at risk
Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Uniform 1 gram dosing
|
Female Weighted Dose TA Patient
n=12 participants at risk
Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing
|
Control
n=25 participants at risk
Historical cohort of primary TKAs performed by BL, none of which received TA.
|
Male Uniform Single Dose TA Patient
n=7 participants at risk
Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Uniform 1 gram dosing
|
Male Weighted Dose TA
n=8 participants at risk
Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Symptomatic DVT
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
0.00%
0/25
|
0.00%
0/7
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Pulmonary Embolism
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
0.00%
0/25
|
0.00%
0/7
|
0.00%
0/8
|
Other adverse events
| Measure |
Female Uniform Single Dose TA Patient
n=13 participants at risk
Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Uniform 1 gram dosing
|
Female Weighted Dose TA Patient
n=12 participants at risk
Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing
|
Control
n=25 participants at risk
Historical cohort of primary TKAs performed by BL, none of which received TA.
|
Male Uniform Single Dose TA Patient
n=7 participants at risk
Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Uniform 1 gram dosing
|
Male Weighted Dose TA
n=8 participants at risk
Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.
Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood Transfusion
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
40.0%
10/25 • Number of events 10
|
0.00%
0/7
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place