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Trial record 55 of 419 for:    TRANEXAMIC ACID

Topical Tranexamic Acid and Acute Blood Loss in Total 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: NCT01370460
Recruitment Status : Completed
First Posted : June 10, 2011
Results First Posted : July 9, 2013
Last Update Posted : July 9, 2013
Sponsor:
Information provided by (Responsible Party):
Michael Laker, Henry Ford Health System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Acute Blood Loss Anemia
Osteoarthritis, Knee
Interventions Drug: Tranexamic Acid
Drug: Placebo
Enrollment 101
Recruitment Details  
Pre-assignment Details We planned on 50 patients per treatment arm (100 patients total) and ended up with 101 patients total. We naturally wished to recruit more than the minimum to avoid the risk of jeopardizing statistical significance. There is no discrepancy that needs to be reconciled, except perhaps this explanation.
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty. 100mL 0.9% NS, applied topically
Period Title: Overall Study
Started 50 51
Completed 50 51
Not Completed 0 0
Arm/Group Title Tranexamic Acid Placebo Total
Hide Arm/Group Description Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty. 100mL 0.9% NS, applied topically Total of all reporting groups
Overall Number of Baseline Participants 50 51 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 101 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  50.0%
26
  51.0%
51
  50.5%
>=65 years
25
  50.0%
25
  49.0%
50
  49.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 51 participants 101 participants
67  (9) 64.5  (8.2) 65.75  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 101 participants
Female
31
  62.0%
39
  76.5%
70
  69.3%
Male
19
  38.0%
12
  23.5%
31
  30.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 51 participants 101 participants
50 51 101
1.Primary Outcome
Title Blood Loss
Hide Description Preoperative and lowest postoperative hemoglobin
Time Frame participants will be followed for the duration of hospital stay, an expected average of 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Tranexamic Acid
Hide Arm/Group Description:
100mL 0.9% NS, applied topically
Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
Overall Number of Participants Analyzed 51 50
Mean (Standard Deviation)
Unit of Measure: mL
1293.1  (532.7) 940.2  (327.1)
2.Secondary Outcome
Title Postoperative Transfusion Rate
Hide Description Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of < 8.0g/dL hemoglobin, or any hemoglobin <7.0 g/dL, precipitated transfusion.
Time Frame participants will be followed for the duration of hospital stay, an expected average of 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:
Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
100mL 0.9% NS, applied topically
Overall Number of Participants Analyzed 50 51
Measure Type: Number
Unit of Measure: participants
0 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adverse Events Not Collected
Hide Arm/Group Description Adverse Events Not Collected
All-Cause Mortality
Adverse Events Not Collected
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adverse Events Not Collected
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adverse Events Not Collected
Affected / at Risk (%)
Total   0/0 
Blood loss was calculated taking change in hemoglobin as described (units g/dL) and converting to blood loss (mL) according to the formulas includes in the papers cited in this entry (Good 2003 Br J Anesthesia; Nadler 1962 Surgery).
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
Layout table for Results Point of Contact information
Name/Title: Andrew Georgiadis, MD
Organization: Henry Ford Health System
Phone: 313-916-7520
EMail: ageorgi1@hfhs.org
Layout table for additonal information
Responsible Party: Michael Laker, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01370460     History of Changes
Other Study ID Numbers: IRB 6669
First Submitted: June 3, 2011
First Posted: June 10, 2011
Results First Submitted: March 27, 2013
Results First Posted: July 9, 2013
Last Update Posted: July 9, 2013