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

Osteoarthritis, Knee Clinical Trial

— TXA Knee  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540226
• Other study ID #: 2015-210
• Status: Completed
• Phase: Phase 4
• Start date: November 19, 2015
• Est. completion date: December 2019

Study information

• Verified date: March 2020
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Drug:
• Intravenous tranexamic acid

• Topical tranexamic acid

• Intravenous saline

• Topical saline

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 hours after tourniquet release
Secondary	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	before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release
Secondary	Levels of Tranexamic Acid		Intraoperative (before cementing), 1 hour after tourniquet release (TQR), 4 hours after tourniquet release(TQR)
Secondary	Calculated Postoperative Blood Loss		Duration of inpatient hospital stay (average of 3 days)
Secondary	Levels of Hemoglobin		1 hour after tourniquet release, POD 1, POD 2
Secondary	Levels of Hematocrit		1 hour after tourniquet release, POD 1, POD 2
Secondary	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.	4 hours after tourniquet release
Secondary	Incidence of Thrombosis (DVT/PE)		Postoperative day 14 (2 weeks after surgery)
Secondary	Patients Who Had 1 Unit of Blood Transfusion Administered		Duration of inpatient hospital stay (average of 3 days)
Secondary	Time to Physical Therapy Discharge		During Hospital Stay
Secondary	Length of Hospital Stay		Length of Hospital Stay
Secondary	Levels of IL-6 in Blood		Intraoperative, 1 hour post Tourniquet Release (TQR), 4 hour post Tourniquet Release (TQR)
Secondary	Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis	Levels of PAP will be measured in peripheral blood and wound drainage	Intraoperative, 1 hour post Tourniquet Release (TQR)
Secondary	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.	Intraoperative, 4 hour post Tourniquet Release (TQR)