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Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical

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ClinicalTrials.gov Identifier: NCT01940523
Recruitment Status : Completed
First Posted : September 12, 2013
Results First Posted : June 14, 2017
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Drug: Topical Tranexamic Acid
Drug: Intravenous Tranexamic Acid
Enrollment 640
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topical Tranexamic Acid Intravenous Tranexamic Acid
Hide Arm/Group Description

3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. Tourniquet will be released.

Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).

1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

Period Title: Overall Study
Started 320 320
Completed 320 320
Not Completed 0 0
Arm/Group Title Topical Tranexamic Acid Intravenous Tranexamic Acid Total
Hide Arm/Group Description

3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).

Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes.

1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

Total of all reporting groups
Overall Number of Baseline Participants 320 320 640
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 320 participants 640 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
146
  45.6%
151
  47.2%
297
  46.4%
>=65 years
174
  54.4%
169
  52.8%
343
  53.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 320 participants 320 participants 640 participants
66.87  (9.42) 66.35  (9.16) 66.6  (9.28)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants 320 participants 640 participants
Female
193
  60.3%
187
  58.4%
380
  59.4%
Male
127
  39.7%
133
  41.6%
260
  40.6%
[1]
Measure Analysis Population Description: The overall enrollment for the study is N=640
1.Primary Outcome
Title Total Blood Loss
Hide Description The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.
Time Frame during surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical Tranexamic Acid Intravenous Tranexamic Acid
Hide Arm/Group Description:

3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).

Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes.

1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

Overall Number of Participants Analyzed 320 320
Mean (Standard Deviation)
Unit of Measure: ml
323.59  (255.89) 271.22  (212.06)
2.Secondary Outcome
Title Drain Output
Hide Description The amount of blood collected by a drain attached to the knee is measured 24 hours after surgery.
Time Frame from end of surgery to 24 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical Tranexamic Acid Intravenous Tranexamic Acid
Hide Arm/Group Description:

3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).

Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes.

1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

Overall Number of Participants Analyzed 320 320
Mean (Standard Deviation)
Unit of Measure: ml
560.13  (297.21) 456.22  (275.39)
3.Secondary Outcome
Title The Number Patients Requiring a Transfusion
Hide Description TThe number Patients requiring a transfusion over the course of the patient's hospital stay.
Time Frame over course of hospital stay (averaging three days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV TXA Group Topical TXA Group
Hide Arm/Group Description:
Kaitlin - Explain this group....
Kaitlin - Explain this group
Overall Number of Participants Analyzed 320 320
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.6%
6
   1.9%
Time Frame During the hospital stay, adverse event data was collected
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topical Tranexamic Acid Intravenous Tranexamic Acid
Hide Arm/Group Description

3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).

Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes.

1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

All-Cause Mortality
Topical Tranexamic Acid Intravenous Tranexamic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Topical Tranexamic Acid Intravenous Tranexamic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/320 (0.00%)   0/320 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Topical Tranexamic Acid Intravenous Tranexamic Acid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/320 (0.00%)   0/320 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Mayman MD
Organization: Hospital for Special Surgery
Phone: 212.774.2024
EMail: maymand@hss.edu
Layout table for additonal information
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01940523     History of Changes
Obsolete Identifiers: NCT02123095
Other Study ID Numbers: 12166
First Submitted: September 9, 2013
First Posted: September 12, 2013
Results First Submitted: March 27, 2017
Results First Posted: June 14, 2017
Last Update Posted: November 27, 2019