Trial Outcomes & Findings for Clinical Trial Comparing Tranexamic Acid (TXA) With Aquamantys Sealer in Total Knee Arthroplasty (TKA) (NCT NCT02374398)
NCT ID: NCT02374398
Last Updated: 2017-01-16
Results Overview
1. Control group- iv placebo normal saline plus regular electrocautery. 2. iv TXA plus regular electrocautery. 3. iv placebo plus Aquamantys system and regular electrocautery. 4. iv TXA and Aquamantys system and regular electrocautery
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
127 participants
Primary outcome timeframe
day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups
Results posted on
2017-01-16
Participant Flow
Participant milestones
| Measure |
Tranexamic Acid
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions
|
Aquamantys System
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts
Aquamantys System: see arm/group descriptions
|
TXA Plus Aquamantys
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions
|
Control
Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
32
|
32
|
|
Overall Study
COMPLETED
|
29
|
31
|
29
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial Comparing Tranexamic Acid (TXA) With Aquamantys Sealer in Total Knee Arthroplasty (TKA)
Baseline characteristics by cohort
| Measure |
Tranexamic Acid
n=29 Participants
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions
|
Aquamantys System
n=31 Participants
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts
Aquamantys System: see arm/group descriptions
|
TXA Plus Aquamantys
n=29 Participants
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions
|
Control
n=32 Participants
Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 8.6 • n=93 Participants
|
64.8 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
61.1 years
STANDARD_DEVIATION 10.5 • n=27 Participants
|
62.9 years
STANDARD_DEVIATION 8.4 • n=483 Participants
|
63.6 years
STANDARD_DEVIATION 8.9 • n=36 Participants
|
|
Gender
Female
|
15 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
66 Participants
n=36 Participants
|
|
Gender
Male
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
55 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=93 Participants
|
31 participants
n=4 Participants
|
29 participants
n=27 Participants
|
32 participants
n=483 Participants
|
121 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups1. Control group- iv placebo normal saline plus regular electrocautery. 2. iv TXA plus regular electrocautery. 3. iv placebo plus Aquamantys system and regular electrocautery. 4. iv TXA and Aquamantys system and regular electrocautery
Outcome measures
| Measure |
Tranexamic Acid
n=29 Participants
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions
|
Aquamantys System
n=31 Participants
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts
Aquamantys System: see arm/group descriptions
|
TXA Plus Aquamantys
n=29 Participants
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions
|
Control
n=32 Participants
Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery
|
|---|---|---|---|---|
|
The Change in Hemoglobin (Hb) From the Day of Surgery
|
2.6 g/dl
Standard Deviation 0.9
|
3.2 g/dl
Standard Deviation 1.1
|
2.6 g/dl
Standard Deviation 1.0
|
3.7 g/dl
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups1. Control group- iv placebo normal saline plus regular electrocautery. 2. iv TXA plus regular electrocautery. 3. iv placebo plus Aquamantys system and regular electrocautery. 4. iv TXA and Aquamantys system and regular electrocautery
Outcome measures
| Measure |
Tranexamic Acid
n=29 Participants
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions
|
Aquamantys System
n=31 Participants
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts
Aquamantys System: see arm/group descriptions
|
TXA Plus Aquamantys
n=29 Participants
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions
|
Control
n=32 Participants
Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery
|
|---|---|---|---|---|
|
The Change in Hematocrit (Ht) From the Day of Surgery
|
7.1 Volume % of RBC in blood
Standard Deviation 2.51
|
8.6 Volume % of RBC in blood
Standard Deviation 3.22
|
6.8 Volume % of RBC in blood
Standard Deviation 2.58
|
10.0 Volume % of RBC in blood
Standard Deviation 3.38
|
SECONDARY outcome
Timeframe: day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groupsThe estimated blood loss was determined with the Gross formula \[23\]. According to a review article published in 2013, Gross's formula though developed in 1983 is still widely used as reported. The formula which is relatively easy to use is described below: Patient blood volume (PBV) = K (1) x height (m) 3 + K (2) x weight (kg) + K (3) Where K (1) = 0.3669 (male), 0.3561(female); K (2) = 0.03219 (male), 0.03308 (female); And K (3) = 0.6041(male), 0.1833 (female) Estimated blood loss = PBV \[Hematocritinitial - Hematocritfinal \] / Hematocritmean Where mean hematocrit is the sum of initial and final hematocrit divided by two.
Outcome measures
| Measure |
Tranexamic Acid
n=29 Participants
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions
|
Aquamantys System
n=31 Participants
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts
Aquamantys System: see arm/group descriptions
|
TXA Plus Aquamantys
n=29 Participants
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions
|
Control
n=32 Participants
Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery
|
|---|---|---|---|---|
|
Post Operative Blood Loss
|
747.9 ml
Standard Deviation 298
|
938.9 ml
Standard Deviation 376
|
746.6 ml
Standard Deviation 270
|
1077.6 ml
Standard Deviation 371
|
SECONDARY outcome
Timeframe: day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groupsCharges per case.
Outcome measures
| Measure |
Tranexamic Acid
n=29 Participants
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions
|
Aquamantys System
n=31 Participants
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts
Aquamantys System: see arm/group descriptions
|
TXA Plus Aquamantys
n=29 Participants
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions
|
Control
n=32 Participants
Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery
|
|---|---|---|---|---|
|
Cost Analysis
|
NA Dollars
Standard Deviation NA
IRB censored
|
NA Dollars
Standard Deviation NA
IRB censored
|
NA Dollars
Standard Deviation NA
IRB censored
|
NA Dollars
Standard Deviation NA
IRB censored
|
SECONDARY outcome
Timeframe: day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groupsComplications: deep venous thrombosis(DVT) or arterial thrombosis, pulmonary embolism(PE), myocardial infarction (MI), cerebrovascular accident (CVA)
Outcome measures
| Measure |
Tranexamic Acid
n=29 Participants
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes
Tranexamic Acid: see arm/group descriptions
|
Aquamantys System
n=31 Participants
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts
Aquamantys System: see arm/group descriptions
|
TXA Plus Aquamantys
n=29 Participants
TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.
The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20-200 watts.
Tranexamic Acid: see arm/group descriptions
Aquamantys System: see arm/group descriptions
|
Control
n=32 Participants
Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes
Control Group: Saline and Standard Elecdrocautery
|
|---|---|---|---|---|
|
Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Tranexamic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aquamantys System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TXA Plus Aquamantys
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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