Trial Outcomes & Findings for Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical (NCT NCT01940523)
NCT ID: NCT01940523
Last Updated: 2019-11-27
Results Overview
The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
640 participants
Primary outcome timeframe
during surgery
Results posted on
2019-11-27
Participant Flow
Participant milestones
| Measure |
Topical Tranexamic Acid
3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. Tourniquet will be released.
Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
|
Intravenous Tranexamic Acid
1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
|
|---|---|---|
|
Overall Study
STARTED
|
320
|
320
|
|
Overall Study
COMPLETED
|
320
|
320
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The overall enrollment for the study is N=640
Baseline characteristics by cohort
| Measure |
Topical Tranexamic Acid
n=320 Participants
3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes.
|
Intravenous Tranexamic Acid
n=320 Participants
1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
|
Total
n=640 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
|
|
Age, Categorical
Between 18 and 65 years
|
146 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
174 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
343 Participants
n=5 Participants
|
|
Age, Continuous
|
66.87 years
STANDARD_DEVIATION 9.42 • n=5 Participants
|
66.35 years
STANDARD_DEVIATION 9.16 • n=7 Participants
|
66.6 years
STANDARD_DEVIATION 9.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
193 Participants
n=5 Participants • The overall enrollment for the study is N=640
|
187 Participants
n=7 Participants • The overall enrollment for the study is N=640
|
380 Participants
n=5 Participants • The overall enrollment for the study is N=640
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants • The overall enrollment for the study is N=640
|
133 Participants
n=7 Participants • The overall enrollment for the study is N=640
|
260 Participants
n=5 Participants • The overall enrollment for the study is N=640
|
PRIMARY outcome
Timeframe: during surgeryThe amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.
Outcome measures
| Measure |
Topical Tranexamic Acid
n=320 Participants
3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes.
|
Intravenous Tranexamic Acid
n=320 Participants
1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
|
|---|---|---|
|
Total Blood Loss
|
323.59 ml
Standard Deviation 255.89
|
271.22 ml
Standard Deviation 212.06
|
SECONDARY outcome
Timeframe: from end of surgery to 24 hours postoperativelyThe amount of blood collected by a drain attached to the knee is measured 24 hours after surgery.
Outcome measures
| Measure |
Topical Tranexamic Acid
n=320 Participants
3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes.
|
Intravenous Tranexamic Acid
n=320 Participants
1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
|
|---|---|---|
|
Drain Output
|
560.13 ml
Standard Deviation 297.21
|
456.22 ml
Standard Deviation 275.39
|
SECONDARY outcome
Timeframe: over course of hospital stay (averaging three days)TThe number Patients requiring a transfusion over the course of the patient's hospital stay.
Outcome measures
| Measure |
Topical Tranexamic Acid
n=320 Participants
3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).
Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes.
|
Intravenous Tranexamic Acid
n=320 Participants
1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
|
|---|---|---|
|
The Number Patients Requiring a Transfusion
|
2 Participants
|
6 Participants
|
Adverse Events
Topical Tranexamic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intravenous Tranexamic Acid
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