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

NCT02540226 | Completed Phase 4 Results DMC

• 1 other identifier: 2015-210
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Tranexamic Acid; Total Knee Arthroplasty; Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

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

  before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release

• Levels of Tranexamic Acid

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

• Calculated Postoperative Blood Loss

  Duration of inpatient hospital stay (average of 3 days)

• Levels of Hemoglobin

  1 hour after tourniquet release, POD 1, POD 2

• Levels of Hematocrit

  1 hour after tourniquet release, POD 1, POD 2

Study Arms (2)

Intravenous tranexamic acid

ACTIVE COMPARATOR

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

Topical tranexamic acid

EXPERIMENTAL

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

Interventions

Intravenous tranexamic acid DRUG

Intravenous tranexamic acid

Topical tranexamic acid DRUG

Topical tranexamic acid

Intravenous saline DRUG

Topical tranexamic acid

Topical saline DRUG

Intravenous tranexamic acid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary unilateral total knee replacement with a participating surgeon
• Patients aged 18-80

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Kethy Jules-Elysee
• Organization: Hospital for Special Surgery

JulesElyseeK@HSS.EDU

212-606-1206

Study Officials

• Kethy Jules-Elysee, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 3, 2015
• Study Start: November 19, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: March 25, 2020
• Results First Posted: March 25, 2020

Record last verified: 2020-03

Locations

US (1)