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

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ClinicalTrials.gov Identifier: NCT02540226
Recruitment Status : Active, not recruiting
First Posted : September 3, 2015
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Tracking Information
First Submitted Date  ICMJE September 1, 2015
First Posted Date  ICMJE September 3, 2015
Last Update Posted Date February 4, 2019
Actual Study Start Date  ICMJE November 19, 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
Levels of plasmin anti-plasmin (PAP) - marker of fibrinolysis [ Time Frame: 4 hours after tourniquet release ]
Levels of PAP will be measured in peripheral blood and wound drainage at 4 hours after tourniquet release.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02540226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
  • Levels of prothrombin fragment 1.2 (PF1.2) - marker of thrombin generation [ Time Frame: Before incision, before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release ]
  • Levels of tranexamic acid [ Time Frame: Before incision, before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release ]
  • Postoperative blood loss [ Time Frame: Duration of inpatient hospital stay (average of 3 days) ]
  • Levels of hemoglobin [ Time Frame: Duration of inpatient hospital stay (average of 3 days) ]
  • Levels of hematocrit [ Time Frame: Duration of inpatient hospital stay (average of 3 days) ]
  • Constavac blood drainage [ Time Frame: 4 hours after tourniquet release ]
  • Incidence of thrombosis (DVT/PE) [ Time Frame: Postoperative day 14 (2 weeks after surgery) ]
  • Units of blood transfusions administered [ Time Frame: Duration of inpatient hospital stay (average of 3 days) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
  • Levels of prothrombin fragment 1.2 (PF1.2) - marker of thrombin generation [ Time Frame: Before incision, 5 minutes after tourniquet release, 1 hour after tourniquet release, 4 hours after tourniquet release ]
  • Levels of D-dimers - markers of fibrinolysis [ Time Frame: Before incision, 5 minutes after tourniquet release, 1 hour after tourniquet release, 4 hours after tourniquet release ]
  • Levels of tranexamic acid [ Time Frame: 5 minutes after tourniquet release, 1 hour after tourniquet release ]
  • Postoperative blood loss [ Time Frame: Duration of inpatient hospital stay (average of 3 days) ]
  • Levels of hemoglobin [ Time Frame: Duration of inpatient hospital stay (average of 3 days) ]
  • Levels of hematocrit [ Time Frame: Duration of inpatient hospital stay (average of 3 days) ]
  • Constavac blood drainage [ Time Frame: 4 hours after tourniquet release ]
  • Incidence of thrombosis (DVT/PE) [ Time Frame: Postoperative day 14 (2 weeks after surgery) ]
  • Units of blood transfusions administered [ Time Frame: Duration of inpatient hospital stay (average of 3 days) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement
Official Title  ICMJE The Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Total Knee Replacement
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Drug: Intravenous tranexamic acid
  • Drug: Topical tranexamic acid
  • Drug: Intravenous saline
  • Drug: Topical saline
Study Arms  ICMJE
  • Active Comparator: Intravenous tranexamic acid
    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.
    Interventions:
    • Drug: Intravenous tranexamic acid
    • Drug: Topical saline
  • Experimental: Topical tranexamic acid
    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.
    Interventions:
    • Drug: Topical tranexamic acid
    • Drug: Intravenous saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 19, 2017)
76
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2015)
66
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02540226
Other Study ID Numbers  ICMJE 2015-210
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital for Special Surgery, New York
Study Sponsor  ICMJE Hospital for Special Surgery, New York
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kethy Jules-Elysee, MD Hospital for Special Surgery, New York
PRS Account Hospital for Special Surgery, New York
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP