Clinical trial NCT02540226: Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement
Official title: The Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: Tranexamic Acid
Total Knee Arthroplasty
Total Knee Replacement
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis
timeFrame: 4 hours after tourniquet release
Secondary outcomes:
measure: Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation
timeFrame: before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release
measure: Levels of Tranexamic Acid
timeFrame: Intraoperative (before cementing), 1 hour after tourniquet release (TQR), 4 hours after tourniquet release(TQR)
measure: Calculated Postoperative Blood Loss
timeFrame: Duration of inpatient hospital stay (average of 3 days)
measure: Levels of Hemoglobin
timeFrame: 1 hour after tourniquet release, POD 1, POD 2
measure: Levels of Hematocrit
timeFrame: 1 hour after tourniquet release, POD 1, POD 2
measure: Constavac Blood Drainage
timeFrame: 4 hours after tourniquet release
measure: Incidence of Thrombosis (DVT/PE)
timeFrame: Postoperative day 14 (2 weeks after surgery)
measure: Patients Who Had 1 Unit of Blood Transfusion Administered
timeFrame: Duration of inpatient hospital stay (average of 3 days)
measure: Time to Physical Therapy Discharge
timeFrame: During Hospital Stay
measure: Length of Hospital Stay
timeFrame: Length of Hospital Stay
measure: Levels of IL-6 in Blood
timeFrame: Intraoperative, 1 hour post Tourniquet Release (TQR), 4 hour post Tourniquet Release (TQR)
measure: Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis
timeFrame: Intraoperative, 1 hour post Tourniquet Release (TQR)
measure: Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation in Wound Blood
timeFrame: Intraoperative, 4 hour post Tourniquet Release (TQR)
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Kethy Jules-Elysee, MD
role: PRINCIPAL_INVESTIGATOR
References: