Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical

NCT01940523 | Completed Phase 4 Results DMC

• 1 other identifier: 12166
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that has been shown to reduce blood drain output and the need for blood transfusions in both its topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that IV and topical administration of tranexamic acid will be equally good at reducing the loss of blood and the need for transfusion immediately following total knee replacement.

Conditions

Osteoarthritis

Keywords

total knee arthroplasty; total knee replacement; tranexamic acid; osteoarthritis; degenerative joint disease

Outcome Measures

Primary Outcomes (1)

• Total Blood Loss

  The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.

  during surgery

Secondary Outcomes (2)

• Drain Output

  from end of surgery to 24 hours postoperatively

• The Number Patients Requiring a Transfusion

  over course of hospital stay (averaging three days)

Study Arms (2)

Topical Tranexamic Acid

ACTIVE COMPARATOR

3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.

Drug: Topical Tranexamic Acid

Intravenous Tranexamic Acid

ACTIVE COMPARATOR

1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

Drug: Intravenous Tranexamic Acid

Interventions

Topical Tranexamic Acid DRUG

3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.

Topical Tranexamic Acid

Intravenous Tranexamic Acid DRUG

1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.

Intravenous Tranexamic Acid

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary total knee replacmeent
• Osteoarthritis
• Unilateral

You may not qualify if:

• Revision surgery
• Donated preoperative autologous blood
• On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)
• Preoperative hepatic or renal dysfunction
• Diagnosis of inflammatory disease
• Diagnosis of inflammatory arthritis
• Pregnant
• Breastfeeding
• Preoperative hemoglobin \<10g/dL
• International Normalized Ratio\>1.4
• Abnormal Partial Thromboplastin Time
• Preoperative platelet count of \<150,000mm\^3
• Creatinine \> 1.4

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Mayo Clinic: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: David Mayman MD
• Organization: Hospital for Special Surgery

maymand@hss.edu

212.774.2024

Study Officials

• David Mayman, 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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 12, 2013
• Study Start: May 1, 2013
• Primary Completion: December 28, 2015
• Study Completion: May 16, 2017
• Last Updated: November 27, 2019
• Results First Posted: June 14, 2017

Record last verified: 2019-11

Locations

US (2)