Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion

NCT03063892 | Recruiting Phase 4 FDA Drug

• 1 other identifier: GG082015
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Tranexamic Acid (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty to reduce the need for intraoperative and postoperative blood transfusions. Limited research is available on its use in hip fracture patients. We hypothesize that the use of TXA preoperatively, perioperatively, and postoperatively will decrease blood loss and need for blood transfusion postoperatively.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• proportion of patients requiring packed Red Blood Cell transfusion

  units, perioperative

  72 hours

Secondary Outcomes (2)

• intraoperative blood loss

  24 hours

• postoperative anemia

  72 hours

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

Will receive intravenous Saline solution placebo bolus dose in the Emergency Center over 10 minutes. The subject will also receive intravenous Saline solution over 8 hours prior to surgery. Another dose will be administered at the time of incision and the final dose three hours later.

Drug: Saline solution

Experimental Arm

EXPERIMENTAL

Will receive intravenous Tranexamic Acid (TXA) 15mg/kg (maximum 1 gram) bolus dose over 10 minutes in the Emergency Center. The subject will also receive an intravenous dose of Tranexamic Acid (TXA) 15mg/kg over 8 hours prior to surgery. Another 15mg/kg dose of Tranexamic Acid (TXA) will be administered over 10 minutes at the time of incision and the final dose (15mg/kg) of Tranexamic Acid (TXA) intravenously over 10 minutes three hours later.

Drug: Tranexamic Acid (TXA)

Interventions

Tranexamic Acid (TXA) DRUG

Tranexamic acid is an antifibrinolytic used to control bleeding

Also known as: Cyklokapron

Experimental Arm

Saline solution DRUG

Saline solution is used as the placebo comparator

Also known as: normal saline

Control Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 60 years
• Hip fracture requiring surgical intervention
• Signs consent and agrees to participate

You may not qualify if:

• Under the age of 60
• Does not sign consent or refuses participation
• Known hypersensitivity to tranexamic acid
• Multiple acute fractures
• Creatinine clearance \<30
• History of seizures
• Active hormone therapy
• History of coagulation abnormality
• History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last year or history or recurrent DVT/PE
• Myocardial infarction (MI) and/or stents within the past year
• History of intracranial hemorrhage
• Acquired defective color vision
• Patients admitted directly to nursing units or surgery without stay in the Emergency Center
• Patients who sustain fracture while hospitalized at ProMedica Toledo Hospital

Sponsors & Collaborators

• Gregory M Georgiadis MD: lead

Study Sites (1)

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Gregory M Georgiadis, MD

  ProMedica Toledo Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Gardner, MSN, RN

CONTACT

419-291-5927; kristin.gardner@promedica.org

Michelle Barhite, RPh

CONTACT

419-291-7709; michelle.barhite@promedica.org

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 INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: February 24, 2017
• Study Start: August 30, 2017
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)