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

Gregory M Georgiadis MD

Status and phase: Enrolling; Phase 4

Conditions: Hip Fractures

Treatments: Drug: Tranexamic Acid (TXA); Drug: Saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03063892

GG082015

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Control Arm

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline solution

Experimental Arm

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic Acid (TXA)