search
Back to results

Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement (TXA Knee)

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intravenous tranexamic acid
Topical tranexamic acid
Intravenous saline
Topical saline
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Tranexamic Acid, Total Knee Arthroplasty, Total Knee Replacement

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing primary unilateral total knee replacement with a participating surgeon
  • Patients aged 18-80

Exclusion Criteria:

  • All patients on steroid therapy regardless of dose, duration, or treatment or those requiring stress-dose steroids preoperatively
  • Patients who will require postoperative use of Coumadin, Xarelto, or Plavix
  • Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 1 week of surgery
  • Hypersensitivity to tranexamic acid
  • Renal dysfunction (Creatinine clearance < 40 ml/min)
  • Hepatic dysfunction (AST or ALT 2x upper limit of normal)
  • Cardiac exclusions: coronary stent, history of myocardial infarction, positive stress test, atrial fibrillation, advanced coronary artery disease
  • Advanced chronic obstructive pulmonary disease or advanced interstitial lung disease
  • History of venous thromboembolism
  • Hypercoagulability (e.g. antiphospholipid syndrome, genetic hypercoagulability with or without prior venous thromboembolism)
  • History of stroke or transient ischemic attack

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intravenous tranexamic acid

Topical tranexamic acid

Arm Description

Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released.

Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given.

Outcomes

Primary Outcome Measures

Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis
Levels of PAP will be measured in peripheral blood and wound drainage at 4 hours after tourniquet release.

Secondary Outcome Measures

Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation
Systemic PAP blood level measured at the following time points - Intraoperative - Before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release
Levels of Tranexamic Acid
Calculated Postoperative Blood Loss
Levels of Hemoglobin
Levels of Hematocrit
Constavac Blood Drainage
A wound drain is connected to a Constavac system, which postoperatively collects, filters, and allows for reinfusion of the patient's own blood. Shed blood passes through an internal prefilter and is collected in a reservoir.
Incidence of Thrombosis (DVT/PE)
Patients Who Had 1 Unit of Blood Transfusion Administered
Time to Physical Therapy Discharge
Length of Hospital Stay
Levels of IL-6 in Blood
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis
Levels of PAP will be measured in peripheral blood and wound drainage
Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation in Wound Blood
The values for the wound blood levels are given as the count of patients who had a level above the threshold of >3600 pmol/L.

Full Information

First Posted
September 1, 2015
Last Updated
March 12, 2020
Sponsor
Hospital for Special Surgery, New York
search

1. Study Identification

Unique Protocol Identification Number
NCT02540226
Brief Title
Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement
Acronym
TXA Knee
Official Title
The Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Total Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 19, 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Tranexamic acid (TXA) is a drug that is being used more frequently at the Hospital for Special Surgery to lessen the amount of blood loss after total knee replacement (TKR). It is an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. TXA can be given either intravenously or topically (placed directly on the open wound) before wound closure. Patients with certain medical conditions have been found to have a high risk of thrombosis after being given intravenous TXA, which may lead to serious complications. However, to date, no high-risk patients have been identified for use of topical TXA. This study will look at thrombogenic markers (proteins found in blood that promote clot formation) after TXA is given either intravenously or topically. If the effect on these markers is similar between intravenous and topical use of TXA, then the safety of topical TXA should be questioned. Of note, these markers have never been measured after TXA has been given topically. As a result, this information would be important for the medical community.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Tranexamic Acid, Total Knee Arthroplasty, Total Knee Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous tranexamic acid
Arm Type
Active Comparator
Arm Description
Patients will receive 1g tranexamic acid in 100mL solution intravenously in the operating room before inflation of the tourniquet. They will again receive the same IV solution in the post-anesthesia care unit, approximately 3 hours after the first solution was given. They will also receive a 75cc topical saline solution approximately 5 minutes before the tourniquet is released.
Arm Title
Topical tranexamic acid
Arm Type
Experimental
Arm Description
Patients will receive 3g tranexamic acid in 75mL solution topically in the operating room, approximately 5 minutes before the tourniquet is released. It will sit for 5 minutes before the solution is suctioned off by the surgeon. They will also receive 2 intravenous saline solutions: one in the operating room before inflation of the tourniquet, and one in the post-anesthesia care unit 3 hours after the first solution was given.
Intervention Type
Drug
Intervention Name(s)
Intravenous tranexamic acid
Intervention Type
Drug
Intervention Name(s)
Topical tranexamic acid
Intervention Type
Drug
Intervention Name(s)
Intravenous saline
Intervention Type
Drug
Intervention Name(s)
Topical saline
Primary Outcome Measure Information:
Title
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis
Description
Levels of PAP will be measured in peripheral blood and wound drainage at 4 hours after tourniquet release.
Time Frame
4 hours after tourniquet release
Secondary Outcome Measure Information:
Title
Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation
Description
Systemic PAP blood level measured at the following time points - Intraoperative - Before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release
Time Frame
before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release
Title
Levels of Tranexamic Acid
Time Frame
Intraoperative (before cementing), 1 hour after tourniquet release (TQR), 4 hours after tourniquet release(TQR)
Title
Calculated Postoperative Blood Loss
Time Frame
Duration of inpatient hospital stay (average of 3 days)
Title
Levels of Hemoglobin
Time Frame
1 hour after tourniquet release, POD 1, POD 2
Title
Levels of Hematocrit
Time Frame
1 hour after tourniquet release, POD 1, POD 2
Title
Constavac Blood Drainage
Description
A wound drain is connected to a Constavac system, which postoperatively collects, filters, and allows for reinfusion of the patient's own blood. Shed blood passes through an internal prefilter and is collected in a reservoir.
Time Frame
4 hours after tourniquet release
Title
Incidence of Thrombosis (DVT/PE)
Time Frame
Postoperative day 14 (2 weeks after surgery)
Title
Patients Who Had 1 Unit of Blood Transfusion Administered
Time Frame
Duration of inpatient hospital stay (average of 3 days)
Title
Time to Physical Therapy Discharge
Time Frame
During Hospital Stay
Title
Length of Hospital Stay
Time Frame
Length of Hospital Stay
Title
Levels of IL-6 in Blood
Time Frame
Intraoperative, 1 hour post Tourniquet Release (TQR), 4 hour post Tourniquet Release (TQR)
Title
Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis
Description
Levels of PAP will be measured in peripheral blood and wound drainage
Time Frame
Intraoperative, 1 hour post Tourniquet Release (TQR)
Title
Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation in Wound Blood
Description
The values for the wound blood levels are given as the count of patients who had a level above the threshold of >3600 pmol/L.
Time Frame
Intraoperative, 4 hour post Tourniquet Release (TQR)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing primary unilateral total knee replacement with a participating surgeon Patients aged 18-80 Exclusion Criteria: All patients on steroid therapy regardless of dose, duration, or treatment or those requiring stress-dose steroids preoperatively Patients who will require postoperative use of Coumadin, Xarelto, or Plavix Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 1 week of surgery Hypersensitivity to tranexamic acid Renal dysfunction (Creatinine clearance < 40 ml/min) Hepatic dysfunction (AST or ALT 2x upper limit of normal) Cardiac exclusions: coronary stent, history of myocardial infarction, positive stress test, atrial fibrillation, advanced coronary artery disease Advanced chronic obstructive pulmonary disease or advanced interstitial lung disease History of venous thromboembolism Hypercoagulability (e.g. antiphospholipid syndrome, genetic hypercoagulability with or without prior venous thromboembolism) History of stroke or transient ischemic attack
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kethy Jules-Elysee, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement

We'll reach out to this number within 24 hrs