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

Phase 4

• Conditions: Hip Fractures
• Interventions: Drug: Saline solution; Drug: Tranexamic Acid (TXA)

• Registration Number: NCT03063892
• Lead Sponsor: Gregory M Georgiadis MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Study Start: 2017-08-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-04
• Primary Completion: 2023-06-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Saline solution	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.
Experimental Arm	Tranexamic Acid (TXA)	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.

Primary Outcome Measures

Name	Time	Method
proportion of patients requiring packed Red Blood Cell transfusion	72 hours	units, perioperative

Secondary Outcome Measures

Name	Time	Method
intraoperative blood loss	24 hours	mL
postoperative anemia	72 hours	Hgb \<7g/dL

Trial Locations

Locations (1)

ProMedica Toledo Hospital; 🇺🇸 Toledo, Ohio, United States