Oral vs. Intravenous TXA Study Proposal: TJA

NCT02233101 | Completed Results

• 1 other identifier: RUSH2233
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Examine oral and intravenous Tranexamic Acid (TXA) to determine whether or not the different routes of drug administration are equivalent in terms of post-operative reduction in hemoglobin, number of transfusions, and post-operative blood loss following TJA surgery. Hypothesis: Oral and intravenous TXA are equivalent routes of drug administration.

Conditions

Blood Loss After Primary Total Joint Arthroplasty; Need for Blood Transfusion After Total Joint Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Required Blood Transfusion

  Patient hemoglobin will be measured during and after surgery for the first 24 hours to determine if a blood transfusion is indicated.

  during or within 24 hours after surgery

Secondary Outcomes (1)

• Other Complications

  participants will be followed for the duration of hospital stay, an expected average of no more than 30 days

Study Arms (2)

Oral Tranexamic Acid

ACTIVE COMPARATOR

Patients will receive either oral or intravenous Tranexamic Acid

Drug: Oral Tranexamic Acid

Intravenous Tranexamic Acid

ACTIVE COMPARATOR

Patients will receive either oral or intravenous Tranexamic Acid

Drug: Intravenous Tranexamic Acid

Interventions

Oral Tranexamic Acid DRUG

patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement

Also known as: TXA

Oral Tranexamic Acid

Intravenous Tranexamic Acid DRUG

Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative

Also known as: TXA

Intravenous Tranexamic Acid

Eligibility Criteria

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

You may qualify if:

• Any patient scheduled for a primary TKA or cementless THA with epidural/spinal anesthesia

You may not qualify if:

• Allergy to TXA, acquired disturbances of color vision, refusal of blood products, pre-op use of anticoagulant therapy within five days before surgery, a history of arterial or venous thromboembolic disease (such as DVT, PE, CVA, TIA), pregnancy, breastfeeding, major comorbidities (such as severe ischemic heart disease \[New York Heart Association Class III or IV\], previous myocardial infarction, severe pulmonary disease, renal impairment, or hepatic failure), patients who decline to participate, any patient undergoing a revision TKA, THA or BHR

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Craig J. Della Valle, MD
• Organization: Rush University Medical Center

craigdellavalle@rushortho.com

312-432-2350

Study Officials

• Craig J Della Valle, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: September 8, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 28, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-10

Locations

US (1)