Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 34 for:    "Collagen Disease" | "Tranexamic Acid"

Weighted Versus Uniform Dose of Tranexamic Acid in Patients Undergoing Primary, Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01651806
Recruitment Status : Completed
First Posted : July 27, 2012
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Brett Levine, MD, Rush University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Osteoarthritis
Intraoperative Bleeding
Interventions Drug: Tranexamic Acid standard dose
Drug: Females Tranexamic Acid weighted dose
Drug: Females receiving a uniform dose of TA
Drug: Males Weighted Dose TA
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Female Uniform Single Dose TA Patient Female Weighted Dose TA Patient Control Male Uniform Single Dose TA Patient Male Weighted Dose TA Patient
Hide Arm/Group Description

Female patients receiving a single dose (1gram) of TA during TKA. Includes all female patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Uniform 1 gram dosing

Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing

Historical cohort of primary TKAs performed by BL, none of which received TA.

A control group was established from a historical cohort of primary TKAs performed by the senior author (BL), none of which received TA. The most relevant Pubmed ID would be 24997651.

Male patients receiving a single dose (1gram) of TA during TKA. Includes all male patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Uniform 1 gram dosing

Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing

Period Title: Overall Study
Started 13 12 25 7 8
Completed 13 12 25 7 8
Not Completed 0 0 0 0 0
Arm/Group Title Female Patients Receiving a Uniform Dose of TA Female Weighted Dose of TA Patients Control Male Patients Receiving a Uniform Dose of TA Male Weighted Dose of TA Patients Total
Hide Arm/Group Description

Female Patients receiving a single dose of 1 gram of TA--includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.

Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.

Female Patients receiving a weighted dose of TA. Will include all patients that will get a weighted dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.

Tranexamic Acid weighted dose: Weighted dose--20mg/kg of the drug will be given

Historical cohort of primary TKAs performed by senior author, none of which received TA.

Male Patients receiving a single dose of 1 gram of TA--includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.

Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.

Male Patients receiving a weighted dose of TA. Will include all patients that will get a weighted dose of the TA during surgery. Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss.

Tranexamic Acid weighted dose: Weighted dose--20mg/kg of the drug will be given

Total of all reporting groups
Overall Number of Baseline Participants 13 12 25 7 8 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants 7 participants 8 participants 65 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  61.5%
5
  41.7%
15
  60.0%
4
  57.1%
3
  37.5%
35
  53.8%
>=65 years
5
  38.5%
7
  58.3%
10
  40.0%
3
  42.9%
5
  62.5%
30
  46.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 25 participants 7 participants 8 participants 65 participants
62.26  (7.31) 66.50  (9.65) 62.40  (10.1) 62.26  (7.31) 66.50  (9.65) 64.38  (8.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants 7 participants 8 participants 65 participants
Female
13
 100.0%
12
 100.0%
15
  60.0%
0
   0.0%
0
   0.0%
40
  61.5%
Male
0
   0.0%
0
   0.0%
10
  40.0%
7
 100.0%
8
 100.0%
25
  38.5%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 13 participants 12 participants 25 participants 7 participants 8 participants 65 participants
32.10  (8.04) 35.40  (8.50) 36  (11.09) 32.10  (8.04) 35.40  (8.50) 33.75  (8.436)
ASA   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a Scale
Number Analyzed 13 participants 12 participants 25 participants 7 participants 8 participants 65 participants
2.53  (0.6) 2.26  (0.7) 2.57  (0.5) 2.53  (0.6) 2.26  (0.7) 2.395  (0.67)
[1]
Measure Description:

American Society of Anesthesiologists (ASA) Score is a global score that assesses the physical status of patients before surgery.

It is sometimed refereed to as ASA-PS, because it is a measure of ‘physical status’.

ASA 1 A normal healthy patient. ASA 2 A patient with mild systemic disease. ASA 3 A patient with severe systemic disease. ASA 4 A patient with severe systemic disease that is a constant threat to life. ASA 5 A moribund patient who is not expected to survive

The ASA Score is a useful global measure of health.

1.Primary Outcome
Title Primary Intra-operative Blood Loss
Hide Description Record intra-operative blood loss through drain output
Time Frame Intra-operative, an average of 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Female Uniform Single Dose TA Patient Female Weighted Dose TA Patient Control Male Uniform Single Dose TA Male Weighted Dose TA Patient
Hide Arm/Group Description:

Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Uniform 1 gram dosing

Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing

Historical cohort of primary TKAs performed by BL, none of which received TA.

Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Uniform 1 gram dosing

Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing

Overall Number of Participants Analyzed 13 12 25 7 8
Mean (Standard Deviation)
Unit of Measure: mL
100.00  (31.69) 65.00  (8.50) 142.80  (197) 100.00  (31.69) 65.00  (8.50)
2.Primary Outcome
Title Document Incidences of DVT and Other Thromboembolic Events.
Hide Description

DVT = Deep Venous thrombosis

Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician.

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Female Uniform Single Dose TA Patient Female Weighted Dose TA Patient Control Male Uniform Single Dose TA Male Weighted Dose TA
Hide Arm/Group Description:

Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Uniform 1 gram dosing

Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing

Historical cohort of primary TKAs performed by BL, none of which received TA.

Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Uniform 1 gram dosing

Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing

Overall Number of Participants Analyzed 13 12 25 7 8
Measure Type: Number
Unit of Measure: Events
1 1 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Female Uniform Single Dose TA Patient Female Weighted Dose TA Patient Control Male Uniform Single Dose TA Patient Male Weighted Dose TA
Hide Arm/Group Description

Female patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Uniform 1 gram dosing

Female patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing

Historical cohort of primary TKAs performed by BL, none of which received TA.

Male patients receiving a single dose (1gram) of TA during TKA. Includes all patients that will get 1 gram dose of the TA during surgery. Postop outcomes will be measured for comparison Postop outcomes wil be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Uniform 1 gram dosing

Male patients receiving a weighted dose (20mg/kg) of TA during TKA. Postop outcomes will be measured for comparison Postop outcomes will be measured for comparison, including hemoglobin, hematocrits and blood loss. Patients will be randomized into one of these two groups.

Tranexamic Acid standard dose: Weighted 20mg/kg gram dosing

All-Cause Mortality
Female Uniform Single Dose TA Patient Female Weighted Dose TA Patient Control Male Uniform Single Dose TA Patient Male Weighted Dose TA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Female Uniform Single Dose TA Patient Female Weighted Dose TA Patient Control Male Uniform Single Dose TA Patient Male Weighted Dose TA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      1/12 (8.33%)      0/25 (0.00%)      0/7 (0.00%)      0/8 (0.00%)    
Blood and lymphatic system disorders           
Symptomatic DVT   0/13 (0.00%)  0 1/12 (8.33%)  1 0/25 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0
Pulmonary Embolism   1/13 (7.69%)  1 0/12 (0.00%)  0 0/25 (0.00%)  0 0/7 (0.00%)  0 0/8 (0.00%)  0
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 5%
Female Uniform Single Dose TA Patient Female Weighted Dose TA Patient Control Male Uniform Single Dose TA Patient Male Weighted Dose TA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      1/12 (8.33%)      10/25 (40.00%)      0/7 (0.00%)      0/8 (0.00%)    
Blood and lymphatic system disorders           
Blood Transfusion   0/13 (0.00%)  0 1/12 (8.33%)  1 10/25 (40.00%)  10 0/7 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Brett Levine, MD
Organization: Rush University Medical Center
Phone: 708.236.2664
Responsible Party: Brett Levine, MD, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01651806     History of Changes
Other Study ID Numbers: 12021202
First Submitted: May 1, 2012
First Posted: July 27, 2012
Results First Submitted: September 26, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017