Trial Outcomes & Findings for Blood Loss Reduction After Total Knee Arthroplasty. Comparison Topical Tranexamic Acid vs Platelet Rich Plasma (NCT NCT02650856)
NCT ID: NCT02650856
Last Updated: 2021-05-26
Results Overview
The blood test will be taken at 6am every day. Using the same laboratory parameters.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
up to 3rd day post operative (Baseline, 24, 48 and 72hrs)
Results posted on
2021-05-26
Participant Flow
Participant milestones
| Measure |
Group 1 Tranexamic Acid
A dosis of 2 gr of tranexamic acid (1000mg/10ml X-GEN pharmaceuticals inc.) diluted in 80ml of physiologic solution and will be divided in two applications.
First application: 40ml of the solution previously prepared is applied over the surgical site and it will be left for five minutes then drained out completely by suction.
Second application: The rest of 40ml of solution previously prepared is applied after placing the final total knee replacement components (femoral, tibial and patellar), over the surgical site and leaving it without draining it by suction.
Group 1 Tranexamic Acid: 2 gr of tranexamic acid will be applied on the surgical site.
|
Group 2 Platelet Rich Plasma
A final volumen of 16 ml of platelet rich plasma is obtained from the forearm vein of the patient and will be divided in two applications.
First application: 8 mL of Platelet rich plasma are applied over the surgical site and are left for five minutes then drained out completely by suction.
Second application: The rest of the 8 mL are applied after placing the final TKR cemented components (femoral, tibial and patellar), over the surgical site and leaving it without draining.
Group 2 Platelet rich plasma: 16ml of platelet rich plasma will be applied of the surgical site
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
Baseline
|
19
|
21
|
|
Overall Study
24 Hours
|
19
|
21
|
|
Overall Study
48 Hours
|
19
|
21
|
|
Overall Study
72 Hours
|
19
|
21
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1 Tranexamic Acid
n=19 Participants
A dosis of 2 gr of tranexamic acid (1000mg/10ml X-GEN pharmaceuticals inc.) diluted in 80ml of physiologic solution and will be divided in two applications.
First application: 40ml of the solution previously prepared is applied over the surgical site and it will be left for five minutes then drained out completely by suction.
Second application: The rest of 40ml of solution previously prepared is applied after placing the final TKR components (femoral, tibial and patellar), over the surgical site and leaving it without draining it by suction.
Group 1 Tranexamic Acid: 2 gr of tranexamic acid will be applied on the surgical site.
|
Group 2 Platelet Rich Plasma
n=21 Participants
A final volumen of 16 ml of platelet rich plasma is obtained from the forearm vein of the patient and will be divided in two applications.
First application: 8 ml of PRP are applied over the surgical site and are left for five minutes then drained out completely by suction.
Second application: The rest of the 8 ml are applied after placing the final TKR cemented components (femoral, tibial and patellar), over the surgical site and leaving it without draining.
Group 2 Platelet rich plasma: 16ml of platelet rich plasma will be applied of the surgical site
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 9.3 • n=19 Participants
|
63.8 years
STANDARD_DEVIATION 6.9 • n=21 Participants
|
66.3175 years
STANDARD_DEVIATION 8.300478525 • n=40 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=19 Participants
|
12 Participants
n=21 Participants
|
21 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=19 Participants
|
9 Participants
n=21 Participants
|
19 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Mexico
|
19 participants
n=19 Participants
|
21 participants
n=21 Participants
|
40 participants
n=40 Participants
|
|
Body Mass Index
|
30.9 kg/m^2
STANDARD_DEVIATION 3.8 • n=19 Participants
|
31.5 kg/m^2
STANDARD_DEVIATION 4.4 • n=21 Participants
|
31.215 kg/m^2
STANDARD_DEVIATION 4.033332989 • n=40 Participants
|
|
Overweight
|
8 Participants
n=19 Participants
|
8 Participants
n=21 Participants
|
16 Participants
n=40 Participants
|
|
Obesity Grade I
|
10 Participants
n=19 Participants
|
10 Participants
n=21 Participants
|
20 Participants
n=40 Participants
|
|
Obesity Grade II
|
0 Participants
n=19 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=40 Participants
|
|
Obesity Grade III
|
1 Participants
n=19 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=40 Participants
|
|
Hemoglobin (g/dL)
|
13.6 g/dL
STANDARD_DEVIATION 1.4 • n=19 Participants
|
13.6 g/dL
STANDARD_DEVIATION 1.5 • n=21 Participants
|
13.6 g/dL
STANDARD_DEVIATION 1.416686274 • n=40 Participants
|
|
Hematocrit (% red blood cells)
|
41.6 %
STANDARD_DEVIATION 4.2 • n=19 Participants
|
41.4 %
STANDARD_DEVIATION 4.2 • n=21 Participants
|
41.495 %
STANDARD_DEVIATION 4.094871793 • n=40 Participants
|
PRIMARY outcome
Timeframe: up to 3rd day post operative (Baseline, 24, 48 and 72hrs)The blood test will be taken at 6am every day. Using the same laboratory parameters.
Outcome measures
| Measure |
Group 1 Tranexamic Acid
n=19 Participants
A dosis of 2 gr of tranexamic acid (1000mg/10ml X-GEN pharmaceuticals inc.) diluted in 80ml of physiologic solution and will be divided in two applications.
First application: 40ml of the solution previously prepared is applied over the surgical site and it will be left for five minutes then drained out completely by suction.
Second application: The rest of 40ml of solution previously prepared is applied after placing the final TKR components (femoral, tibial and patellar), over the surgical site and leaving it without draining it by suction.
Group 1 Tranexamic Acid: 2 gr of tranexamic acid will be applied on the surgical site.
|
Group 2 Platelet Rich Plasma
n=21 Participants
A final volume of 16 ml of platelet rich plasma is obtained from the forearm vein of the patient and will be divided in two applications.
First application: 8 ml of PRP are applied over the surgical site and are left for five minutes then drained out completely by suction.
Second application: The rest of the 8 ml are applied after placing the final TKR cemented components (femoral, tibial and patellar), over the surgical site and leaving it without draining.
Group 2 Platelet rich plasma: 16ml of platelet rich plasma will be applied of the surgical site
|
|---|---|---|
|
Therapeutic Effect on Hemoglobin Level
Baseline
|
13.6 g/dL
Standard Deviation 1.4
|
13.6 g/dL
Standard Deviation 1.5
|
|
Therapeutic Effect on Hemoglobin Level
24 hours
|
10.3 g/dL
Standard Deviation 1.6
|
9.9 g/dL
Standard Deviation 1.1
|
|
Therapeutic Effect on Hemoglobin Level
48 hours
|
9.5 g/dL
Standard Deviation 1.4
|
9.2 g/dL
Standard Deviation 1.3
|
|
Therapeutic Effect on Hemoglobin Level
72 hours
|
9.3 g/dL
Standard Deviation 1.5
|
9.1 g/dL
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: up to 3rd day post operative (Baseline, 24, 48 and 72hrs)The blood test will be taken at 6am every day. Using the same laboratory parameters.
Outcome measures
| Measure |
Group 1 Tranexamic Acid
n=19 Participants
A dosis of 2 gr of tranexamic acid (1000mg/10ml X-GEN pharmaceuticals inc.) diluted in 80ml of physiologic solution and will be divided in two applications.
First application: 40ml of the solution previously prepared is applied over the surgical site and it will be left for five minutes then drained out completely by suction.
Second application: The rest of 40ml of solution previously prepared is applied after placing the final TKR components (femoral, tibial and patellar), over the surgical site and leaving it without draining it by suction.
Group 1 Tranexamic Acid: 2 gr of tranexamic acid will be applied on the surgical site.
|
Group 2 Platelet Rich Plasma
n=21 Participants
A final volume of 16 ml of platelet rich plasma is obtained from the forearm vein of the patient and will be divided in two applications.
First application: 8 ml of PRP are applied over the surgical site and are left for five minutes then drained out completely by suction.
Second application: The rest of the 8 ml are applied after placing the final TKR cemented components (femoral, tibial and patellar), over the surgical site and leaving it without draining.
Group 2 Platelet rich plasma: 16ml of platelet rich plasma will be applied of the surgical site
|
|---|---|---|
|
Therapeutic Effect on Hematocrit Level
Baseline
|
41.7 percentage of Hematocrite
Standard Deviation 4.2
|
41.5 percentage of Hematocrite
Standard Deviation 4.8
|
|
Therapeutic Effect on Hematocrit Level
24 hours
|
31.6 percentage of Hematocrite
Standard Deviation 5.0
|
29.8 percentage of Hematocrite
Standard Deviation 3.0
|
|
Therapeutic Effect on Hematocrit Level
48 hours
|
29.1 percentage of Hematocrite
Standard Deviation 4.4
|
27.7 percentage of Hematocrite
Standard Deviation 3.3
|
|
Therapeutic Effect on Hematocrit Level
72 hours
|
28.6 percentage of Hematocrite
Standard Deviation 4.7
|
27.3 percentage of Hematocrite
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: up to 2nd day post operative (24 and 48 hrs)The blood quantification will be taken at 6am every day.
Outcome measures
| Measure |
Group 1 Tranexamic Acid
n=19 Participants
A dosis of 2 gr of tranexamic acid (1000mg/10ml X-GEN pharmaceuticals inc.) diluted in 80ml of physiologic solution and will be divided in two applications.
First application: 40ml of the solution previously prepared is applied over the surgical site and it will be left for five minutes then drained out completely by suction.
Second application: The rest of 40ml of solution previously prepared is applied after placing the final TKR components (femoral, tibial and patellar), over the surgical site and leaving it without draining it by suction.
Group 1 Tranexamic Acid: 2 gr of tranexamic acid will be applied on the surgical site.
|
Group 2 Platelet Rich Plasma
n=21 Participants
A final volume of 16 ml of platelet rich plasma is obtained from the forearm vein of the patient and will be divided in two applications.
First application: 8 ml of PRP are applied over the surgical site and are left for five minutes then drained out completely by suction.
Second application: The rest of the 8 ml are applied after placing the final TKR cemented components (femoral, tibial and patellar), over the surgical site and leaving it without draining.
Group 2 Platelet rich plasma: 16ml of platelet rich plasma will be applied of the surgical site
|
|---|---|---|
|
Therapeutic Effect on Drainage Quantification
24 hours
|
246.4 mL
Standard Deviation 152.3
|
263.2 mL
Standard Deviation 192.6
|
|
Therapeutic Effect on Drainage Quantification
48 hours
|
120.8 mL
Standard Deviation 94.6
|
140.2 mL
Standard Deviation 127.7
|
Adverse Events
Group 1 Tranexamic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 Platelet Rich Plasma
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