Tranexamic Acid in Orthopaedic Trauma Surgery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02080494

Enrollment

101

Registered

2014-03-06

Start date

2012-05-31

Completion date

2018-12-31

Last updated

2018-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Fracture, Surgery, Trauma

Keywords

tranexamic acid, orthopaedic trauma, pelvic fracture, hip fracture, femur fracture, blood loss

Brief 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.

Interventions

DRUGTranexamic Acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
hemoglobin value	through postoperative day four

Secondary

Measure	Time frame
hematocrit value	through postoperative day four
number of units of allogenic blood transfused	through postoperative day four

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026