Trial Outcomes & Findings for Tranexamic Acid Dosing for Total Joint Arthroplasty (NCT NCT02584725)

NCT ID: NCT02584725

Last Updated: 2020-10-30

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 84 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2020-10-30

Participant Flow

Participant milestones

Measure	5 mg/kg/Dose Tranexamic Acid 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Overall Study STARTED	28	28	28
Overall Study COMPLETED	28	28	28
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tranexamic Acid Dosing for Total Joint Arthroplasty

Baseline characteristics by cohort

Measure	5 mg/kg/Dose Tranexamic Acid n=28 Participants 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 Participants 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 Participants 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	Total n=84 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	30 Participants n=4 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	20 Participants n=7 Participants	16 Participants n=5 Participants	54 Participants n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	17 Participants n=7 Participants	20 Participants n=5 Participants	59 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	25 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 day

Outcome measures

Measure	5 mg/kg/Dose Tranexamic Acid n=28 Participants 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 Participants 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 Participants 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Change in Hemoglobin From Baseline to the First Post-operative Day (POD#1)	2.15 g/dl Standard Deviation 1.19	2.06 g/dl Standard Deviation 0.81	2.11 g/dl Standard Deviation 0.97

SECONDARY outcome

Timeframe: 6 hours

Outcome measures

Measure	5 mg/kg/Dose Tranexamic Acid n=28 Participants 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 Participants 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 Participants 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Change in Hemoglobin From Baseline to POD#0	1.34 g/dL Standard Deviation 1.19	1.30 g/dL Standard Deviation 0.71	1.16 g/dL Standard Deviation 0.94

SECONDARY outcome

Timeframe: 2 days

Outcome measures

Measure	5 mg/kg/Dose Tranexamic Acid n=28 Participants 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 Participants 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 Participants 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Change in Hemoglobin From Baseline to POD#2	2.50 g/dL Standard Deviation 1.2	2.59 g/dL Standard Deviation 0.67	2.28 g/dL Standard Deviation 1.1

SECONDARY outcome

Timeframe: 2 days

Number or count of participants requiring transfusion.

Outcome measures

Measure	5 mg/kg/Dose Tranexamic Acid n=28 Participants 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 Participants 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 Participants 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Number of Participants Requiring Blood Transfusion From the Intra-operative Period Into the End of POD#2	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 2 hours

Outcome measures

Measure	5 mg/kg/Dose Tranexamic Acid n=28 Participants 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 Participants 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 Participants 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Total Estimated Intra-operative Blood Loss	321.43 mL Standard Deviation 276.21	322.32 mL Standard Deviation 261.84	376.25 mL Standard Deviation 314.08

SECONDARY outcome

Timeframe: 2 hours

Outcome measures

Measure	5 mg/kg/Dose Tranexamic Acid n=28 Participants 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 Participants 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 Participants 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Volume of Blood in the Surgical Suction Canister at the End of Surgery	282.50 mL Standard Deviation 262.19	283.93 mL Standard Deviation 240.31	329.11 mL Standard Deviation 285.89

SECONDARY outcome

Timeframe: 2 days

Count of participants able to sit on POD1 and POD2 as assessed by a mobility assessment.

Outcome measures

Measure	5 mg/kg/Dose Tranexamic Acid n=28 Participants 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 Participants 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 Participants 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Count of Participants Able to Sit on Post-Operative Day 1 (POD1) and Post-Operative Day 2 (POD2) Count of Participants Able to Sit POD1	26 Participants	28 Participants	28 Participants
Count of Participants Able to Sit on Post-Operative Day 1 (POD1) and Post-Operative Day 2 (POD2) Count of Participants Able to Sit POD2	27 Participants	28 Participants	28 Participants

SECONDARY outcome

Timeframe: 2 days

Count of participants able to stand on POD1 and POD2 as assessed by a mobility assessment.

Outcome measures

Measure	5 mg/kg/Dose Tranexamic Acid n=28 Participants 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 Participants 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 Participants 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Count of Participants Able to Stand on POD1 and POD2 Count of Participants Able to Stand POD1	25 Participants	28 Participants	27 Participants
Count of Participants Able to Stand on POD1 and POD2 Count of Participants Able to Stand POD2	28 Participants	28 Participants	28 Participants

SECONDARY outcome

Timeframe: 2 days

Count of participants able to Walk on POD1 and POD2 as assessed by a mobility assessment.

Outcome measures

Measure	5 mg/kg/Dose Tranexamic Acid n=28 Participants 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 Participants 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 Participants 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Count of Participants Able to Walk on POD1 and POD2 Count of Participants Able to Walk POD1	26 Participants	28 Participants	25 Participants
Count of Participants Able to Walk on POD1 and POD2 Count of Participants Able to Walk POD2	28 Participants	28 Participants	28 Participants

SECONDARY outcome

Timeframe: 2 days

The VAS measures pain on a scale of 0-10, with 0=no pain and 10=worst possible pain.

Outcome measures

Measure	5 mg/kg/Dose Tranexamic Acid n=28 Participants 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 Participants 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 Participants 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Visual Analog Scale (VAS) Pain Scores on POD#1 and POD#2 VAS Pain Score POD#2	4.63 score on a scale Standard Deviation 2.62	3.89 score on a scale Standard Deviation 2.69	4.32 score on a scale Standard Deviation 2.09
Visual Analog Scale (VAS) Pain Scores on POD#1 and POD#2 VAS Pain Score POD#1	5.18 score on a scale Standard Deviation 2.76	3.82 score on a scale Standard Deviation 2.98	4.36 score on a scale Standard Deviation 2.23

SECONDARY outcome

Timeframe: 2 days

Patients' self-reported scores on a scale of overall feeling of wellbeing on POD#1 and POD#2. Scores range from 0-10, with 0= "worst I have ever felt" and 10= "feel just as well as before surgery."

Outcome measures

Measure	5 mg/kg/Dose Tranexamic Acid n=28 Participants 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 Participants 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 Participants 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Wellbeing Questionnaire Score on POD#1 and POD#2 Wellbeing Score POD#2	7.15 score on a scale Standard Deviation 2.96	8.04 score on a scale Standard Deviation 2.08	7.39 score on a scale Standard Deviation 2.13
Wellbeing Questionnaire Score on POD#1 and POD#2 Wellbeing Score POD#1	6.54 score on a scale Standard Deviation 2.91	7.71 score on a scale Standard Deviation 2.62	7.04 score on a scale Standard Deviation 2.25

SECONDARY outcome

Timeframe: 2 days

Outcome measures

Measure	5 mg/kg/Dose Tranexamic Acid n=28 Participants 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 Participants 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 Participants 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Count of Seizure, Transient Ischemic Attack, Stroke, Myocardial Infarction, Deep Venous Thrombosis, and Pulmonary Embolus Post-operative Seizure	0 participants	0 participants	0 participants
Count of Seizure, Transient Ischemic Attack, Stroke, Myocardial Infarction, Deep Venous Thrombosis, and Pulmonary Embolus Post-operative Transient Ischemic Attack	0 participants	0 participants	0 participants
Count of Seizure, Transient Ischemic Attack, Stroke, Myocardial Infarction, Deep Venous Thrombosis, and Pulmonary Embolus Post-operative Myocardial Infarction	0 participants	0 participants	0 participants
Count of Seizure, Transient Ischemic Attack, Stroke, Myocardial Infarction, Deep Venous Thrombosis, and Pulmonary Embolus Post-operative Deep Vein Thrombosis	0 participants	0 participants	0 participants
Count of Seizure, Transient Ischemic Attack, Stroke, Myocardial Infarction, Deep Venous Thrombosis, and Pulmonary Embolus Post-operative Pulmonary Embolus	0 participants	0 participants	1 participants

Adverse Events

5 mg/kg/Dose Tranexamic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

10 mg/kg/Dose Tranexamic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

15 mg/kg/Dose Tranexamic Acid

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	5 mg/kg/Dose Tranexamic Acid n=28 participants at risk 5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	10 mg/kg/Dose Tranexamic Acid n=28 participants at risk 10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins	15 mg/kg/Dose Tranexamic Acid n=28 participants at risk 15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins
Respiratory, thoracic and mediastinal disorders Pulmonary Embolus	0.00% 0/28 • Up to 2 Days Monitoring of potential adverse events will be done via clinical exam in the first 48 hours post-operatively. The definition of adverse event does not differ from the ClinicalTrials.gov definition.	0.00% 0/28 • Up to 2 Days Monitoring of potential adverse events will be done via clinical exam in the first 48 hours post-operatively. The definition of adverse event does not differ from the ClinicalTrials.gov definition.	3.6% 1/28 • Number of events 1 • Up to 2 Days Monitoring of potential adverse events will be done via clinical exam in the first 48 hours post-operatively. The definition of adverse event does not differ from the ClinicalTrials.gov definition.

Additional Information

Robert Maniker, MD

Columbia University Irving Medical Center

Phone: 212-305-9876

Email: rm3046@cumc.columbia.edu

Results disclosure agreements

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