Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/6/2019 |
| Start Date: | November 19, 2015 |
| End Date: | December 2019 |
The Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Total 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.
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.
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
We found this trial at
1
site
535 E 70th St
New York, New York 10021
New York, New York 10021
(212) 606-1000
Principal Investigator: Kethy M Jules-Elysee, MD
Phone: 646-714-6794
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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