Tranexamic Acid in Orthopaedic Trauma Surgery

Surgery Clinical Trial

Official title:

Tranexamic Acid in Orthopaedic Trauma Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02080494
• Other study ID #: 11-036
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2012
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative blood loss. This study is a prospective, randomized controlled trial investigating the use of tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss (>300mL) is expected.

The hypothesis of this study is that tranexamic acid will be associated with a decrease in post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in patients who have fracture surgery around the hip and knee.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 101
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with isolated fractures of the pelvic ring, acetabulum, femur or tibia that will require open reduction and internal fixation

• Expected blood loss is greater than 300 mL

• Age = 18

• Skeletal maturity

Exclusion Criteria:

• Pregnant or breastfeeding

• Patients taking oral contraceptives

• Contraindication to venous thromboembolic event (VTE) prophylaxis (intracranial, intrathoracic, intra-abdominal bleeding or spine fractures)

• Patients requiring operative intervention for other injuries (orthopaedic or non-orthopaedic)

• Known hypercoagulable state including history of prescribed anti-coagulation (warfarin, plavix, low molecular weight heparin)

• Renal Insufficiency (creatinine greater than 1.5mg/dL)

• Open fractures

Related Conditions & MeSH terms

• Blood Loss
• Fracture
• Hemorrhage
• Surgery
• Trauma
• Wounds and Injuries

Intervention

Drug:
• Tranexamic Acid

Locations

Country	Name	City	State
United States	Erlanger Health System	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin value		through postoperative day four
Secondary	hematocrit value		through postoperative day four
Secondary	number of units of allogenic blood transfused		through postoperative day four