Tranexamic Acid in Orthopaedic Trauma Surgery
1 other identifier
interventional
101
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 8, 2014
CompletedFirst Posted
Study publicly available on registry
March 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 11, 2018
May 1, 2018
6.6 years
January 8, 2014
July 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
hemoglobin value
through postoperative day four
Secondary Outcomes (2)
hematocrit value
through postoperative day four
number of units of allogenic blood transfused
through postoperative day four
Study Arms (2)
Control
NO INTERVENTIONNo tranexamic acid given
Tranexamic Acid
EXPERIMENTAL15 mg/kg preoperative IV dose followed by another 15 mg/kg IV dose three hours after the initial dose
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erlanger Health System
Chattanooga, Tennessee, 37403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dirk W Kiner, MD
UTCOM Chattanooga / Erlanger Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2014
First Posted
March 6, 2014
Study Start
May 1, 2012
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
July 11, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share