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Completed

NCT Number: NCT02540226

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous tranexamic acid

Drug

Topical tranexamic acid

Drug

Intravenous saline

Drug

Topical saline

Drug

Primary outcomes

  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 outcomes

  1. Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation

    Time frame: before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release

    Systemic PAP blood level measured at the following time points - Intraoperative - Before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release

  2. Levels of Tranexamic Acid

    Time frame: Intraoperative (before cementing), 1 hour after tourniquet release (TQR), 4 hours after tourniquet release(TQR)

  3. Calculated Postoperative Blood Loss

    Time frame: Duration of inpatient hospital stay (average of 3 days)

  4. Levels of Hemoglobin

    Time frame: 1 hour after tourniquet release, POD 1, POD 2

  5. Levels of Hematocrit

    Time frame: 1 hour after tourniquet release, POD 1, POD 2

  6. Constavac Blood Drainage

    Time frame: 4 hours after tourniquet release

    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.

  7. Incidence of Thrombosis (DVT/PE)

    Time frame: Postoperative day 14 (2 weeks after surgery)

  8. Patients Who Had 1 Unit of Blood Transfusion Administered

    Time frame: Duration of inpatient hospital stay (average of 3 days)

  9. Time to Physical Therapy Discharge

    Time frame: During Hospital Stay

  10. Length of Hospital Stay

    Time frame: Length of Hospital Stay

  11. Levels of IL-6 in Blood

    Time frame: Intraoperative, 1 hour post Tourniquet Release (TQR), 4 hour post Tourniquet Release (TQR)

  12. Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis

    Time frame: Intraoperative, 1 hour post Tourniquet Release (TQR)

    Levels of PAP will be measured in peripheral blood and wound drainage

  13. Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation in Wound Blood

    Time frame: Intraoperative, 4 hour post Tourniquet Release (TQR)

    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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Acronym: TXA Knee

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Sep 3, 2015
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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