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Trial record 15 of 34 for:    "Collagen Disease" | "Tranexamic Acid"

Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT01850394
Recruitment Status : Completed
First Posted : May 9, 2013
Results First Posted : December 13, 2013
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):
Viroj Kawinwonggowit, Mahidol University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Primary Osteoarthritis of Knee Nos
Interventions Drug: Tranexamic Acid
Drug: Physiologic saline
Enrollment 152
Recruitment Details The patients, who planned to undergo primary total knee replacement, were recruited from medical clinics before setting the operative schedule between 2009 and 2010.
Pre-assignment Details Seventeen patients were excluded that including refusal to participate (4 patients), serum creatinine more than 2.0 mg% (4 patients), rheumatoid arthritis (4 patients), abnormal coagulogram (3 patients), and history of stroke (2 patients)
Arm/Group Title Control Group TXA-250 Group TXA-500 Group
Hide Arm/Group Description

physiologic saline 25 ml

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

A total of 25-ml solution with 250-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

A total of 25-ml solution with 500-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

Period Title: Overall Study
Started 45 45 45
Completed 45 45 45
Not Completed 0 0 0
Arm/Group Title Control Group TXA-250 Group TXA-500 Group Total
Hide Arm/Group Description

physiologic saline 25 ml

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

A total of 25-ml solution with 250-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

A total of 25-ml solution with 500-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

Total of all reporting groups
Overall Number of Baseline Participants 45 45 45 135
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 45 participants 135 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  44.4%
20
  44.4%
13
  28.9%
53
  39.3%
>=65 years
25
  55.6%
25
  55.6%
32
  71.1%
82
  60.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 45 participants 45 participants 135 participants
66.2  (7.3) 67.6  (8.7) 68.1  (6.2) 67.3  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 45 participants 135 participants
Female
43
  95.6%
42
  93.3%
40
  88.9%
125
  92.6%
Male
2
   4.4%
3
   6.7%
5
  11.1%
10
   7.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 45 participants 45 participants 45 participants 135 participants
45 45 45 135
1.Primary Outcome
Title Perioperative Blood Loss
Hide Description
  • Drainage blood loss measured by accumulating total drainage volume postoperatively
  • Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day
Time Frame 5 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Using intention-to-treat analysis
Arm/Group Title Control Group TXA-250 Group TXA-500 Group
Hide Arm/Group Description:

physiologic saline 25 ml

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

A total of 25-ml solution with 250-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

A total of 25-ml solution with 500-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

Overall Number of Participants Analyzed 45 45 45
Median (Standard Deviation)
Unit of Measure: ml
Drainage blood loss 546.9  (273.0) 475.0  (254.4) 430.2  (224.0)
Calculated total blood loss 329.2  (119.4) 239.7  (83.7) 217.2  (86.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, TXA-250 Group, TXA-500 Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 180
Parameter Dispersion
Type: Standard Deviation
Value: 300
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, TXA-250 Group, TXA-500 Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 150
Parameter Dispersion
Type: Standard Deviation
Value: 200
Estimation Comments [Not Specified]
2.Primary Outcome
Title Total Hemoglobin Loss
Hide Description Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day
Time Frame 5 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Use intention-to-treat analysis
Arm/Group Title Control Group TXA-250 Group TXA-500 Group
Hide Arm/Group Description:

physiologic saline 25 ml

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

A total of 25-ml solution with 250-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

A total of 25-ml solution with 500-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

Overall Number of Participants Analyzed 45 45 45
Mean (Standard Deviation)
Unit of Measure: g/dL
2.9  (1.2) 2.2  (0.7) 2.2  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, TXA-250 Group, TXA-500 Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.66
Parameter Dispersion
Type: Standard Deviation
Value: 1.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Knee Function Scores
Hide Description

Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period.

  1. Knee Society Knee Score using for rating knee function measurement and subdivided into two parts; knee score and function score 1.1. Knee score : calculated from pain, presence of deformity, total range of flexion, alignment, and stability. Total score is 100 (0-100), more score means better.

    1.2. Function score : calculated from patient’s ability to walk and climb stairs. The score ranges from 0-100, more score means better.

  2. Western Ontario and McMaster Universities Arthritis Index or WOMAC score : a widely used, standardized questionnaires for evaluating the condition of patients with knee osteoarthritis, including pain (score = 0-20), stiffness (0-8), and functional limitation (0-68). Total score ranges from 0-68, lower score means better.
Time Frame 1 year after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Using intention-to-treat analysis
Arm/Group Title Control Group TXA-250 Group TXA-500 Group
Hide Arm/Group Description:

physiologic saline 25 ml

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

A total of 25-ml solution with 250-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

A total of 25-ml solution with 500-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

Overall Number of Participants Analyzed 45 45 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
Knee Society Knee score at 1 year 148.9  (10.1) 151.2  (9.1) 150.9  (9.3)
WOMAC score at 1 year 15.5  (6.6) 15.1  (6.2) 14.5  (7.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, TXA-250 Group, TXA-500 Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 140
Parameter Dispersion
Type: Standard Deviation
Value: 15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, TXA-250 Group, TXA-500 Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15
Parameter Dispersion
Type: Standard Deviation
Value: 4
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Patients Required Blood Transfusion
Hide Description [Not Specified]
Time Frame postoperative period (5 days after surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group TXA-250 Group TXA-500 Group
Hide Arm/Group Description:

physiologic saline 25 ml

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

A total of 25-ml solution with 250-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

A total of 25-ml solution with 500-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

Overall Number of Participants Analyzed 45 45 45
Measure Type: Number
Unit of Measure: participants
10 6 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, TXA-250 Group, TXA-500 Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.1
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Patients Having Postoperative Complications
Hide Description

Postoperative complications were measured as an incidence of the following complications;

  • wound hematoma
  • surgical site infection
  • systemic infection
  • deep vein thrombosis
  • pulmonary embolism
  • knee stiffness requiring manipulation
  • medical complication such as myocardial infarction, congestive hear failure
Time Frame postoperative 1-year period
Hide Outcome Measure Data
Hide Analysis Population Description
Using Intention-to-treat analysis
Arm/Group Title Control Group TXA-250 Group TXA-500 Group
Hide Arm/Group Description:

physiologic saline 25 ml

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

A total of 25-ml solution with 250-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

A total of 25-ml solution with 500-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

Overall Number of Participants Analyzed 45 45 45
Measure Type: Number
Unit of Measure: participants
Re-clamp incidence 6 1 0
Re-dressing incidence 3 0 0
Venous thromboembolic complication 4 1 2
Congestive heart failure 0 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, TXA-250 Group, TXA-500 Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.02
Estimation Comments [Not Specified]
Time Frame 5 days
Adverse Event Reporting Description

Perioperative venous thromboembolic complications

  • deep vein thrombosis screened with duplex doppler ultrasound in all cases
  • pulmonary embolism diagnosed with clinical hypoxemia and confirmed with computer tomography angiogram
 
Arm/Group Title Control Group TXA-250 Group TXA-500 Group
Hide Arm/Group Description

physiologic saline 25 ml

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

A total of 25-ml solution with 250-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

A total of 25-ml solution with 500-mg tranexamic acid

Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure

All-Cause Mortality
Control Group TXA-250 Group TXA-500 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control Group TXA-250 Group TXA-500 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/45 (8.89%)      1/45 (2.22%)      2/45 (4.44%)    
Blood and lymphatic system disorders       
Venous thromboembolic complication   4/45 (8.89%)  4 1/45 (2.22%)  1 2/45 (4.44%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group TXA-250 Group TXA-500 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/45 (0.00%)      0/45 (0.00%)      0/45 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Paphon Sa-ngasoongsong
Organization: Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Phone: 66-2-2011589
Publications:
Responsible Party: Viroj Kawinwonggowit, Mahidol University
ClinicalTrials.gov Identifier: NCT01850394     History of Changes
Other Study ID Numbers: ID 01-53-06
First Submitted: May 2, 2013
First Posted: May 9, 2013
Results First Submitted: May 9, 2013
Results First Posted: December 13, 2013
Last Update Posted: December 13, 2013