Trial Outcomes & Findings for Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement (NCT NCT02540226)

Results Overview

Levels of PAP will be measured in peripheral blood and wound drainage at 4 hours after tourniquet release.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

76 participants

Primary outcome timeframe

4 hours after tourniquet release

Results posted on

2020-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Intravenous Tranexamic Acid Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Overall Study STARTED	33	33
Overall Study COMPLETED	31	32
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline	Total n=63 Participants Total of all reporting groups
Age, Continuous	65.6 years STANDARD_DEVIATION 8.4 • n=5 Participants	65.0 years STANDARD_DEVIATION 6.9 • n=7 Participants	65.3 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	20 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	28 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	32 participants n=7 Participants	63 participants n=5 Participants
BMI	31.6 kg/m^2 STANDARD_DEVIATION 7.1 • n=5 Participants	31.1 kg/m^2 STANDARD_DEVIATION 5.2 • n=7 Participants	31.4 kg/m^2 STANDARD_DEVIATION 6.2 • n=5 Participants
ASA Grade (II/III) ASA II	28 Participants n=5 Participants	32 Participants n=7 Participants	60 Participants n=5 Participants
ASA Grade (II/III) ASA III	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Preoperative Hemoglobin	135 g/dL STANDARD_DEVIATION 11 • n=5 Participants	138 g/dL STANDARD_DEVIATION 11 • n=7 Participants	136.4 g/dL STANDARD_DEVIATION 11.3 • n=5 Participants
Preoperative Hematocrit	40.8 % STANDARD_DEVIATION 3.2 • n=5 Participants	41.0 % STANDARD_DEVIATION 2.8 • n=7 Participants	40.9 % STANDARD_DEVIATION 3.0 • n=5 Participants
Preoperative Platelet count	241 platelets/uL STANDARD_DEVIATION 50 • n=5 Participants	241 platelets/uL STANDARD_DEVIATION 60 • n=7 Participants	241.0 platelets/uL STANDARD_DEVIATION 55.1 • n=5 Participants

PRIMARY outcome

Timeframe: 4 hours after tourniquet release

Population: A wound drain was not inserted in all patients - hence why wound blood was not able to be collected 4 hours post tourniquet release.

Levels of PAP will be measured in peripheral blood and wound drainage at 4 hours after tourniquet release.

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis Systemic PAP blood level 4 HR post TQR	117.8 ug/L Standard Deviation 478.9	1280.7 ug/L Standard Deviation 646.5
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis Wound PAP Blood Level 4 HR post TQR	1032 ug/L Standard Deviation 354.4	1041.2 ug/L Standard Deviation 365.8

SECONDARY outcome

Timeframe: before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release

Systemic PAP blood level measured at the following time points - Intraoperative - Before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation Intraoperative (before cemeting)	400.2 pmol/L Standard Deviation 235.6	377.3 pmol/L Standard Deviation 218.4
Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation 1 hour after tourniquet release	661 pmol/L Standard Deviation 243.5	636.2 pmol/L Standard Deviation 241.6
Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation 4 hour after tourniquet release	812.9 pmol/L Standard Deviation 349.9	868.8 pmol/L Standard Deviation 336.2

SECONDARY outcome

Timeframe: Intraoperative (before cementing), 1 hour after tourniquet release (TQR), 4 hours after tourniquet release(TQR)

Population: Blood was collected from the A-Line or CostaVac Drain. If no drain was placed, the wound 4 hour post TQR blood could not be collected.

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Levels of Tranexamic Acid Systemic Level - Intraoperative (before cemeting)	31.0 mg/L Standard Deviation 15.2	3.9 mg/L Standard Deviation 13.1
Levels of Tranexamic Acid Systemic Level - 1 Hour Post TQR	19.9 mg/L Standard Deviation 8.3	7.2 mg/L Standard Deviation 7.4
Levels of Tranexamic Acid Systemic Level - 4 Hour Post TQR	27.4 mg/L Standard Deviation 13.7	5.2 mg/L Standard Deviation 8.8
Levels of Tranexamic Acid Wound Level - Intraoperative (before cemeting)	21.1 mg/L Standard Deviation 11.2	2.2 mg/L Standard Deviation 9.2
Levels of Tranexamic Acid Wound Level - 4 Hour Post TQR	37.9 mg/L Standard Deviation 16.1	31.4 mg/L Standard Deviation 47.0

SECONDARY outcome

Timeframe: Duration of inpatient hospital stay (average of 3 days)

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Calculated Postoperative Blood Loss	1237 mL Interval 780.0 to 1456.0	1405 mL Interval 1208.0 to 1700.0

SECONDARY outcome

Timeframe: 1 hour after tourniquet release, POD 1, POD 2

Population: The number in one or more rows differs from overall number analyzed because patients were either discharged early or there was a missing blood draw.

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Levels of Hemoglobin 1 hour after tourniquet release	11.29 g/dL Standard Deviation 1.21	11.41 g/dL Standard Deviation 1.02
Levels of Hemoglobin POD1	11.12 g/dL Standard Deviation 1.04	10.53 g/dL Standard Deviation 0.13
Levels of Hemoglobin POD2	10.28 g/dL Standard Deviation 1.19	9.94 g/dL Standard Deviation 1.03

SECONDARY outcome

Timeframe: 1 hour after tourniquet release, POD 1, POD 2

Population: The number in one or more rows differs from overall number analyzed because patients were either discharged early or there was a missing blood draw.

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Levels of Hematocrit 1 hour after tourniquet release	33.6 % of red blood cells in blood Standard Deviation 3.6	33.8 % of red blood cells in blood Standard Deviation 2.6
Levels of Hematocrit POD1	35.6 % of red blood cells in blood Standard Deviation 12	31.5 % of red blood cells in blood Standard Deviation 4
Levels of Hematocrit POD2	31 % of red blood cells in blood Standard Deviation 3.5	29.8 % of red blood cells in blood Standard Deviation 2.7

SECONDARY outcome

Timeframe: 4 hours after tourniquet release

Population: Some patients did not get a contavac drain put in hence the discrepancy in analysis population description.

A wound drain is connected to a Constavac system, which postoperatively collects, filters, and allows for reinfusion of the patient's own blood. Shed blood passes through an internal prefilter and is collected in a reservoir.

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=28 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Constavac Blood Drainage	100 mL Interval 90.0 to 185.0	170 mL Interval 118.0 to 240.0

SECONDARY outcome

Timeframe: Postoperative day 14 (2 weeks after surgery)

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Incidence of Thrombosis (DVT/PE)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Duration of inpatient hospital stay (average of 3 days)

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Patients Who Had 1 Unit of Blood Transfusion Administered	1 Participants	1 Participants

SECONDARY outcome

Timeframe: During Hospital Stay

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Time to Physical Therapy Discharge	1.9 days Interval 1.8 to 2.8	2.9 days Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: Length of Hospital Stay

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Length of Hospital Stay	2.3 days Interval 2.0 to 2.9	3.0 days Interval 2.5 to 3.2

SECONDARY outcome

Timeframe: Intraoperative, 1 hour post Tourniquet Release (TQR), 4 hour post Tourniquet Release (TQR)

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Levels of IL-6 in Blood Intraoperative (before cemeting)	1.1 pg/mL Standard Deviation 0.9	3.9 pg/mL Standard Deviation 11.5
Levels of IL-6 in Blood Systemic Level - 1 Hour Post TQR	1.8 pg/mL Standard Deviation 1.2	5 pg/mL Standard Deviation 12.7
Levels of IL-6 in Blood Systemic Level - 4 Hour Post TQR	17.2 pg/mL Standard Deviation 14.9	25.6 pg/mL Standard Deviation 33.9
Levels of IL-6 in Blood Wound Blood - Intraoperative (before cemeting)	5.2 pg/mL Standard Deviation 7.6	6.7 pg/mL Standard Deviation 12.1
Levels of IL-6 in Blood Wound Level - 4 Hour Post TQR	5774.8 pg/mL Standard Deviation 4360.7	4497.6 pg/mL Standard Deviation 3325.5

SECONDARY outcome

Timeframe: Intraoperative, 1 hour post Tourniquet Release (TQR)

Levels of PAP will be measured in peripheral blood and wound drainage

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis Systemic Blood - Intraoperative (before cemeting)	31.0 mg/L Standard Deviation 15.2	3.9 mg/L Standard Deviation 13.1
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis Systemic Level - 1 Hour Post TQR	19.9 mg/L Standard Deviation 8.3	7.2 mg/L Standard Deviation 7.4
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis Wound Blood - Intraoperative	21.1 mg/L Standard Deviation 11.2	2.2 mg/L Standard Deviation 9.2

SECONDARY outcome

Timeframe: Intraoperative, 4 hour post Tourniquet Release (TQR)

Population: Blood samples could not be collected at the 4-hour post tourniquet release for some patients.

The values for the wound blood levels are given as the count of patients who had a level above the threshold of \>3600 pmol/L.

Outcome measures

Outcome measures
Measure	Intravenous Tranexamic Acid n=31 Participants Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released. Intravenous tranexamic acid Topical saline	Topical Tranexamic Acid n=32 Participants Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given. Topical tranexamic acid Intravenous saline
Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation in Wound Blood Intraoperative (before cemeting)	16 Participants	14 Participants
Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation in Wound Blood 4 hour after tourniquet release	13 Participants	11 Participants

Adverse Events

Intravenous Tranexamic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Topical 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

Dr. Kethy Jules-Elysee

Hospital for Special Surgery

Phone: 212-606-1206

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place