Trial Outcomes & Findings for Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty (NCT NCT03328832)
NCT ID: NCT03328832
Last Updated: 2021-08-10
Results Overview
Total blood loss was calculated according to Nadler et al., which used maximum postoperative reduction of the Hb level adjust for weight and height of the patient. The formula is as follows, Total blood loss = (Total blood volume x \[change in Hb level / preoperative Hb level\])x1000+volume transfused
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
From the operation to the postoperative day 3 or 4
Results posted on
2021-08-10
Participant Flow
Between September 2017 and September 2018, a consecutive series of 125 patients who underwent unilateral TKA were assessed in terms of their eligibility for inclusion for this study. 35 patients were excluded based on the exclusion criteria, eight patients did not withhold antiplatelet drugs or anticoagulants 7 days before surgery, and 12 other patients declined to participate in the study. Total 70 patients were enrolled and randomly assigned into 2 groups
Participant milestones
| Measure |
Combined Topical TXA and Floseal
Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
Floseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
Topical TXA Alone
Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Combined Topical TXA and Floseal
Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
Floseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
Topical TXA Alone
Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Combined Topical TXA and Floseal
n=35 Participants
Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
Floseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
Topical TXA Alone
n=34 Participants
Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.26 years
STANDARD_DEVIATION 5.88 • n=5 Participants
|
67.47 years
STANDARD_DEVIATION 4.00 • n=7 Participants
|
68.38 years
STANDARD_DEVIATION 4.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
35 participants
n=5 Participants
|
34 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Body mass index
|
28.69 kg/m^2
STANDARD_DEVIATION 3.77 • n=5 Participants
|
27.44 kg/m^2
STANDARD_DEVIATION 4.44 • n=7 Participants
|
28.07 kg/m^2
STANDARD_DEVIATION 4.11 • n=5 Participants
|
|
Preop Hb
|
13.79 g/dL
STANDARD_DEVIATION 1.39 • n=5 Participants
|
13.39 g/dL
STANDARD_DEVIATION 0.85 • n=7 Participants
|
13.61 g/dL
STANDARD_DEVIATION 1.03 • n=5 Participants
|
PRIMARY outcome
Timeframe: From the operation to the postoperative day 3 or 4Total blood loss was calculated according to Nadler et al., which used maximum postoperative reduction of the Hb level adjust for weight and height of the patient. The formula is as follows, Total blood loss = (Total blood volume x \[change in Hb level / preoperative Hb level\])x1000+volume transfused
Outcome measures
| Measure |
Combined Topical TXA and Floseal
n=35 Participants
Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
Floseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
Topical TXA Alone
n=34 Participants
Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
|---|---|---|
|
Total Blood Loss After Operation
|
678 ml
Standard Deviation 203
|
733 ml
Standard Deviation 217
|
SECONDARY outcome
Timeframe: From the operation to the postoperative day 3 or 4We will record the event of blood transfusion, and calculate the incidence of transfusion
Outcome measures
| Measure |
Combined Topical TXA and Floseal
n=35 Participants
Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
Floseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
Topical TXA Alone
n=34 Participants
Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
|---|---|---|
|
Blood Transfusion Rate
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: within 30 days of the operationThe composite of any venous thromoembolism events, ischemic heart attacks, cerebrovascular accidents
Outcome measures
| Measure |
Combined Topical TXA and Floseal
n=35 Participants
Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
Floseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
Topical TXA Alone
n=34 Participants
Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
|---|---|---|
|
Incidence of Thrombosis Events
|
0 Participants
|
0 Participants
|
Adverse Events
Combined Topical TXA and Floseal
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Topical TXA Alone
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Combined Topical TXA and Floseal
n=35 participants at risk
Floseal® was applied on potential bleeding sites before prosthesis implantation, and intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
Floseal®: Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
Topical TXA Alone
n=34 participants at risk
Intraarticular application of topical tranexamic acid after capsule closure Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
Topical tranexamic acid: Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
rivaroxaban (10mg): Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
|
|---|---|---|
|
Surgical and medical procedures
Ecchymosis
|
48.6%
17/35 • Number of events 17 • 3 months
|
44.1%
15/34 • Number of events 15 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place