Trial Outcomes & Findings for Tranexamic Acid Dosing for Major Joint Replacement Surgery (NCT NCT05075200)

NCT ID: NCT05075200

Last Updated: 2025-12-09

Results Overview

Measurement of serial blood plasma TXA concentration to build a pharmacokinetic model and dosing regimens for patients within both groups. Curve-stripping of the plasma TXA concentration data according to the 2-compartment model was used to calculate a single value for the measure per participant, which was then averaged.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: Collected at 5/15/30/60/90/180/360/540 minutes after bolus
• Results posted on: 2025-12-09

Participant Flow

Participant milestones

Measure	Group I Participants with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (and dialysis) Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Group II Participants with GFR ≥ 60 mL/min/1.73m2 Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.
Overall Study STARTED	10	11
Overall Study COMPLETED	10	11
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 I n=10 Participants Participants with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (and dialysis) Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Group II n=11 Participants Participants with GFR ≥ 60 mL/min/1.73m2 Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Total n=21 Participants Total of all reporting groups
Age, Continuous	77 years n=10 Participants	72 years n=11 Participants	73 years n=21 Participants
Sex: Female, Male Female	7 Participants n=10 Participants	4 Participants n=11 Participants	11 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=10 Participants	7 Participants n=11 Participants	10 Participants n=21 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	10 participants n=10 Participants	11 participants n=11 Participants	21 participants n=21 Participants
Weight	80.4 Kilograms n=10 Participants	81 Kilograms n=11 Participants	81 Kilograms n=21 Participants
eGFR	46 mL/min/1.73 m^2 n=10 Participants	79 mL/min/1.73 m^2 n=11 Participants	60 mL/min/1.73 m^2 n=21 Participants
Surgery type Hip Replacement	4 Participants n=10 Participants	3 Participants n=11 Participants	7 Participants n=21 Participants
Surgery type Knee Replacement	6 Participants n=10 Participants	8 Participants n=11 Participants	14 Participants n=21 Participants

PRIMARY outcome

Timeframe: Collected at 5/15/30/60/90/180/360/540 minutes after bolus

Measurement of serial blood plasma TXA concentration to build a pharmacokinetic model and dosing regimens for patients within both groups. Curve-stripping of the plasma TXA concentration data according to the 2-compartment model was used to calculate a single value for the measure per participant, which was then averaged.

Outcome measures

Measure	Group I n=10 Participants Participants with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (and dialysis) Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Group II n=11 Participants Participants with GFR ≥ 60 mL/min/1.73m2 Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.
Blood Plasma TXA Concentration - Total Body Clearance	58.0 mL/min Standard Deviation 21.0	116 mL/min Standard Deviation 23.9

PRIMARY outcome

Timeframe: Collected at 5/15/30/60/90/180/360/540 minutes after bolus

Measurement of serial blood plasma TXA concentration to build a pharmacokinetic model and dosing regimens for patients within both groups. Curve-stripping of the plasma TXA concentration data according to the 2-compartment model was used to calculate a single value for the measure per participant, which was then averaged.

Outcome measures

Measure	Group I n=10 Participants Participants with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (and dialysis) Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Group II n=11 Participants Participants with GFR ≥ 60 mL/min/1.73m2 Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.
Blood Plasma TXA Concentration - Area Under the Concentration-time Curve	31031 (mg/L)h Standard Deviation 10142	15808 (mg/L)h Standard Deviation 3475

PRIMARY outcome

Timeframe: Collected at 5/15/30/60/90/180/360/540 minutes after bolus

Measurement of serial blood plasma TXA concentration to build a pharmacokinetic model and dosing regimens for patients within both groups. Curve-stripping of the plasma TXA concentration data according to the 2-compartment model was used to calculate a single value for the measure per participant, which was then averaged.

Outcome measures

Measure	Group I n=10 Participants Participants with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (and dialysis) Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Group II n=11 Participants Participants with GFR ≥ 60 mL/min/1.73m2 Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.
Blood Plasma TXA Concentration - Elimination Rate Constant	0.004 /min Standard Deviation 0.002	0.007 /min Standard Deviation 0.002

PRIMARY outcome

Timeframe: Collected at 5/15/30/60/90/180/360/540 minutes after bolus

Measurement of serial blood plasma TXA concentration to build a pharmacokinetic model and dosing regimens for patients within both groups. Curve-stripping of the plasma TXA concentration data according to the 2-compartment model was used to calculate a single value for the measure per participant, which was then averaged.

Outcome measures

Measure	Group I n=10 Participants Participants with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (and dialysis) Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Group II n=11 Participants Participants with GFR ≥ 60 mL/min/1.73m2 Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.
Blood Plasma TXA Concentration - Volume of Central Compartment	13.8 L Standard Deviation 3.8	15.9 L Standard Deviation 3.2

PRIMARY outcome

Timeframe: Collected at 5/15/30/60/90/180/360/540 minutes after bolus

Measurement of serial blood plasma TXA concentration to build a pharmacokinetic model and dosing regimens for patients within both groups. Curve-stripping of the plasma TXA concentration data according to the 2-compartment model was used to calculate a single value for the measure per participant, which was then averaged.

Outcome measures

Measure	Group I n=10 Participants Participants with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (and dialysis) Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Group II n=11 Participants Participants with GFR ≥ 60 mL/min/1.73m2 Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.
Blood Plasma TXA Concentration - Steady State Volume of Distribution	20.9 L Standard Deviation 6.43	25.4 L Standard Deviation 5.8

SECONDARY outcome

Timeframe: Assessed intraoperatively on the day of surgery

intraoperative measurement of blood loss

Outcome measures

Measure	Group I n=10 Participants Participants with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (and dialysis) Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Group II n=11 Participants Participants with GFR ≥ 60 mL/min/1.73m2 Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.
Intraoperative Blood Loss and Transfusion	100 mL Interval 100.0 to 187.5	100 mL Interval 100.0 to 250.0

SECONDARY outcome

Timeframe: Perioperative

perioperative value of hemoglobin. The % change is calculated as the postoperative hemoglobin minus preoperative hemoglobin, and reported as a percentage of pre-operative hemoglobin. Negative values indicate a reduction in hemoglobin.

Outcome measures

Measure	Group I n=10 Participants Participants with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (and dialysis) Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Group II n=11 Participants Participants with GFR ≥ 60 mL/min/1.73m2 Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.
% Change in Pre- and Postoperative Hemoglobin	-14.4 % decrease Standard Deviation 6.7	-15.1 % decrease Standard Deviation 7.9

SECONDARY outcome

Timeframe: Collected within 24 hours after surgery

postoperative value of creatinine

Outcome measures

Measure	Group I n=10 Participants Participants with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (and dialysis) Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Group II n=11 Participants Participants with GFR ≥ 60 mL/min/1.73m2 Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.
Postoperative Creatinine	100 umol/L Interval 87.25 to 120.75	82 umol/L Interval 65.5 to 83.0

SECONDARY outcome

Timeframe: Collected within 24 hours after surgery

postoperative value of the estimated glomerular filtration rate

Outcome measures

Measure	Group I n=10 Participants Participants with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (and dialysis) Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Group II n=11 Participants Participants with GFR ≥ 60 mL/min/1.73m2 Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.
Postoperative eGFR	51 ml/min/1.72 m^2 Interval 47.0 to 58.0	85 ml/min/1.72 m^2 Interval 78.0 to 89.0

SECONDARY outcome

Timeframe: Baseline until hospital discharge (up to 7 days after surgery)

death occurring during the hospital stay

Outcome measures

Measure	Group I n=10 Participants Participants with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (and dialysis) Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Group II n=11 Participants Participants with GFR ≥ 60 mL/min/1.73m2 Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.
In-hospital Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline until hospital discharge (up to 7 days after surgery)

duration of hospitalization

Outcome measures

Measure	Group I n=10 Participants Participants with glomerular filtration rate (GFR) \< 60 mL/min/1.73m2 (and dialysis) Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.	Group II n=11 Participants Participants with GFR ≥ 60 mL/min/1.73m2 Tranexamic acid: Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.
Hospital Length of Stay	33.2 hours Interval 30.8 to 57.0	29.6 hours Interval 28.1 to 30.9

Adverse Events

Group I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group II

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. Angela Jerath

Sunnybrook Health Sciences Centre

Phone: 416-480-4864

Email: angela.jerath@sunnybrook.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place