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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

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Intravenous tranexamic acid Drug: Topical tranexamic acid Drug: Intravenous saline Drug: Topical saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Total Knee Replacement
Actual Study Start Date : November 19, 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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.
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.
Drug: Topical tranexamic acid
Drug: Intravenous saline



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. Levels of tranexamic acid [ Time Frame: Before incision, before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release ]
  3. Postoperative blood loss [ Time Frame: Duration of inpatient hospital stay (average of 3 days) ]
  4. Levels of hemoglobin [ Time Frame: Duration of inpatient hospital stay (average of 3 days) ]
  5. Levels of hematocrit [ Time Frame: Duration of inpatient hospital stay (average of 3 days) ]
  6. Constavac blood drainage [ Time Frame: 4 hours after tourniquet release ]
  7. Incidence of thrombosis (DVT/PE) [ Time Frame: Postoperative day 14 (2 weeks after surgery) ]
  8. Units of blood transfusions administered [ Time Frame: Duration of inpatient hospital stay (average of 3 days) ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540226


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Kethy Jules-Elysee, MD Hospital for Special Surgery, New York

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02540226     History of Changes
Other Study ID Numbers: 2015-210
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2018
Keywords provided by Hospital for Special Surgery, New York:
Tranexamic Acid
Total Knee Arthroplasty
Total Knee Replacement
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants