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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-30

Study Completion Date

2026-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control Arm

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.

Group Type PLACEBO_COMPARATOR

Saline solution

Intervention Type DRUG

Saline solution is used as the placebo comparator

Experimental Arm

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.

Group Type EXPERIMENTAL

Tranexamic Acid (TXA)

Intervention Type DRUG

Tranexamic acid is an antifibrinolytic used to control bleeding

Interventions

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Tranexamic Acid (TXA)

Tranexamic acid is an antifibrinolytic used to control bleeding

Intervention Type DRUG

Saline solution

Saline solution is used as the placebo comparator

Intervention Type DRUG

Other Intervention Names

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Cyklokapron normal saline

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No