Tranexamic Acid Dosing for Total Joint Arthroplasty

NCT02584725 | Completed Phase 4 Results

• 1 other identifier: AAAM9601
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the effect of increasing doses of tranexamic acid (TXA) on limiting blood loss during total knee and total hip arthroplasty as defined by a change in hemoglobin from pre-operative baseline to the first post-operative day.

Conditions

Arthropathy of Hip; Arthropathy of Knee

Keywords

Tranexamic Acid; Total Joint Arthroplasty; Intraoperative Blood Loss

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin From Baseline to the First Post-operative Day (POD#1)

  1 day

Secondary Outcomes (11)

• Change in Hemoglobin From Baseline to POD#0

  6 hours

• Change in Hemoglobin From Baseline to POD#2

  2 days

• Number of Participants Requiring Blood Transfusion From the Intra-operative Period Into the End of POD#2

  2 days

• Total Estimated Intra-operative Blood Loss

  2 hours

• Volume of Blood in the Surgical Suction Canister at the End of Surgery

  2 hours

Study Arms (3)

5 mg/kg/dose tranexamic acid

ACTIVE COMPARATOR

5 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins

Drug: Tranexamic Acid

10 mg/kg/dose tranexamic acid

ACTIVE COMPARATOR

10 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins

Drug: Tranexamic Acid

15 mg/kg/dose tranexamic acid

ACTIVE COMPARATOR

15 mg/kg tranexamic acid IV, administered twice, once 20 minutes prior to surgical incision and once at when surgical wound closure begins

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

Comparison of 3 different doses of the drug

Also known as: Lysteda

10 mg/kg/dose tranexamic acid; 15 mg/kg/dose tranexamic acid; 5 mg/kg/dose tranexamic acid

Eligibility Criteria

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

You may qualify if:

• Patients undergoing primary unilateral total knee arthroplasty or primary unilateral total hip arthroplasty under spinal anesthesia at Columbia University Medical Center/ New York Presbyterian Hospital.

You may not qualify if:

• Non-English speaking.
• Patient refusal to participate.
• Weight exceeding 100kg.
• Baseline hemoglobin of less than 10.
• Repeat, revision, or bilateral surgery.
• Known sensitivity or allergy to Tranexamic Acid.
• Active intra-vascular clotting.
• History of coagulopathy or congenital thrombophilia.
• Thromboembolic event in the 12 months prior to enrollment.
• Percutaneous coronary intervention requiring a drug eluting stent in the 12 months prior to enrollment.
• History of anticoagulant medication use unless stopped prior to surgery as recommended by and in accordance with the American Society of Regional Anesthesia Guidelines.
• Use of a general anesthetic in the current anesthetic.
• Blood transfusion for a hemoglobin value which deviates from the study's transfusion protocol.

Sponsors & Collaborators

• Columbia University: lead

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Robert Maniker, MD
• Organization: Columbia University Irving Medical Center

rm3046@cumc.columbia.edu

212-305-9876

Study Officials

• Robert Maniker, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 23, 2015
• Study Start: December 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 30, 2020
• Results First Posted: October 30, 2020

Record last verified: 2020-10