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NCT03063892 Clinical Trial

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

Hip Fractures Clinical Trial

Official title:
Evaluating the Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion in Hip Fracture Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03063892
Other study ID # GG082015
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 30, 2017
Est. completion date September 1, 2023

Study information
Verified date September 2021
Source ProMedica Health System
Contact Sara Seegert, MSN, RN
Phone 419-291-3441
Email sara.seegert@promedica.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tranexamic Acid (TXA)
Tranexamic acid is an antifibrinolytic used to control bleeding
• Saline solution
Saline solution is used as the placebo comparator

Locations
Country Name City State
United States ProMedica Toledo Hospital Toledo Ohio

Sponsors (1)
Lead Sponsor Collaborator
Gregory M Georgiadis MD

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary proportion of patients requiring packed Red Blood Cell transfusion units, perioperative 72 hours
Secondary intraoperative blood loss mL 24 hours
Secondary postoperative anemia Hgb <7g/dL 72 hours
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