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Tranexamic Acid in Orthopaedic Trauma Surgery

Primary Purpose

Blood Loss, Trauma, Fracture

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tranexamic Acid

About this trial

This is an interventional prevention trial for Blood Loss focused on measuring tranexamic acid, orthopaedic trauma, pelvic fracture, hip fracture, femur fracture, blood loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Erlanger Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Tranexamic Acid

Arm Description

No tranexamic acid given

15 mg/kg preoperative IV dose followed by another 15 mg/kg IV dose three hours after the initial dose

Outcomes

Primary Outcome Measures

hemoglobin value

Secondary Outcome Measures

hematocrit value

number of units of allogenic blood transfused

Full Information

NCT ID

NCT02080494

First Posted

January 8, 2014

Last Updated

July 9, 2018

Sponsor

University of Tennessee

1. Study Identification

Unique Protocol Identification Number

NCT02080494

Brief Title

Tranexamic Acid in Orthopaedic Trauma Surgery

Official Title

Tranexamic Acid in Orthopaedic Trauma Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Tennessee

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blood Loss, Trauma, Fracture, Surgery

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

No tranexamic acid given

Arm Title

Tranexamic Acid

Arm Type

Experimental

Arm Description

15 mg/kg preoperative IV dose followed by another 15 mg/kg IV dose three hours after the initial dose

Intervention Type

Drug

Intervention Name(s)

Tranexamic Acid

Primary Outcome Measure Information:

Title

hemoglobin value

Time Frame

through postoperative day four

Secondary Outcome Measure Information:

Title

hematocrit value

Time Frame

through postoperative day four

Title

number of units of allogenic blood transfused

Time Frame

through postoperative day four

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dirk W Kiner, MD

Organizational Affiliation

UTCOM Chattanooga / Erlanger Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Erlanger Health System

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37403

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Tranexamic Acid in Orthopaedic Trauma Surgery

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