Non-inferiority Trial of Oral Tranexamic Acid vs. Intravenous Tranexamic Acid in Joint Replacement Surgery

NCT02438566 | Unknown Phase 3 DMC

• 1 other identifier: 654455
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to determine if the oral form of a medication (tranexamic acid) to reduce bleeding can be used in place of an intravenous (IV) form, to learn the best way to give tranexamic acid: either a pill by mouth, or a solution by vein.

Conditions

Osteoarthritis; Blood Loss, Surgical; Blood Loss, Postoperative

Keywords

Tranexamic Acid; Blood Loss; Total Hip Replacement; Bilateral Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Lower number of units of blood required for transfusion.

  Lower number of units of blood required for transfusion in the OR and post-operatively, hospital-wide.

  2 Years

Secondary Outcomes (3)

• Lower incidences of patients requiring blood transfusion.

  2 Years

• Lower Blood Loss in Patients

  Hospital Stay: 1-3 days.

• Length of Stay

  1-3 Days

Study Arms (2)

Oral Tranexamic Acid (OTA)

ACTIVE COMPARATOR

Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. OTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU.

Drug: Tranexamic Acid (Oral)

Intravenous Tranexamic Acid (IVTA)

ACTIVE COMPARATOR

Subjects will be randomized 1:1 to receive either IVTA or OTA with corresponding placebos. IVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure.

Drug: Tranexamic Acid (Intravenous)

Interventions

Tranexamic Acid (Oral) DRUG

OTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU.

Also known as: trans-4-(aminomethyl)cyclohexanecarboxylic acid, Lysteda

Oral Tranexamic Acid (OTA)

Tranexamic Acid (Intravenous) DRUG

IVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure.

Also known as: trans-4-(aminomethyl)cyclohexanecarboxylic acid, Cyklokapron

Intravenous Tranexamic Acid (IVTA)

Eligibility Criteria

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

You may qualify if:

• To be included into this study, you must be undergoing hip or bilateral knee replacement surgery.
• You must be healthy enough to undergo joint replacement surgery.
• You must be able to understand and sign an informed consent.
• You must be at least 18 years of age.

You may not qualify if:

• You cannot be under 18 years of age.
• You cannot be undergoing revision hip or revision bilateral knee replacement surgery.
• You cannot be part of this study if you are allergic to the medication
• You cannot participate if you are on hemodialysis,
• You cannot participate if you have active coronary artery disease and if you have various vascular stents in place.
• You will also be excluded if you have ever had a blood clot (deep vein thrombosis (DVT), pulmonary embolism (PE)).
• You will also be excluded if you have ever had a cerebral or subarachnoid hemorrhage (brain bleeding), or stroke (cerebral vascular accident or transient ischemic attack).
• If you are on estrogen-containing medication (hormone replacement therapy or oral contraceptive) within 7 days of surgery, you cannot take part in this study.

Sponsors & Collaborators

• The New England Baptist Hospital: lead

Study Sites (1)

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Blood Loss, Surgical; Postoperative Hemorrhage; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kenneth Bauer, MD

  New England Baptist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: May 8, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2017
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

US (1)