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Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid (TXA)

Primary Purpose

Acetabulum Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acetabulum Fractures focused on measuring Acetabulum Fractures, Pelvic Ring Injuries, Tranexamic Acid

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients (18 years of age or greater) with acetabulum fractures and/or pelvic ring injuries that require operative fixation via an open surgical approach

Exclusion Criteria:

  • Revision surgery
  • Surgery occurring more than 2 weeks post-injury
  • History of blood dyscrasia or renal insufficiency
  • History of any thromboembolic disease
  • Pregnancy or nursing, color vision defects
  • History of retinal detachment/degeneration
  • Intracranial hemorrhage
  • Hypersensitivity to tranexamic acid
  • Contraceptive Use (estrogens/progestins)
  • FEIBA (anti-inhibitor coagulant complex) use

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic Acid

Placebo

Arm Description

Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.

The control group will receive a similar volume load of normal saline and maintenance doses.

Outcomes

Primary Outcome Measures

Intra-operative Blood Loss

Secondary Outcome Measures

Number of Participants That Required an Allogenic Transfusion

Full Information

First Posted
January 29, 2014
Last Updated
January 30, 2018
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02051686
Brief Title
Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid
Acronym
TXA
Official Title
Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid: A Prospective, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or hip socket fractures that require surgery. TXA is FDA-approved in patients with hemophilia for short-term use to reduce hemorrhage and the need for replacement blood during tooth extraction. However, it has also been used extensively in severely injured patients after major trauma and during elective hip and knee replacements. Previous studies indicate TXA may reduce blood loss and the need for blood transfusions while being safe for use in most patients. TXA is fairly inexpensive and easy to obtain. The purpose of this study is to determine if TXA will make surgery in patients with pelvis and/or hip socket fractures safer and more cost efficient.
Detailed Description
Study candidates will be identified as they present to the University Hospital emergency room and will be recruited for enrollment. Randomization will occur by electronic randomization software. Prior to surgery, the pharmacy will be notified of an enrolled patient and will be responsible for randomization and creating either a placebo intravenous dose or a treatment study dose. Both study groups will receive the standard of care treatment for intra-operative hemorrhage control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acetabulum Fractures
Keywords
Acetabulum Fractures, Pelvic Ring Injuries, Tranexamic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid
Arm Type
Active Comparator
Arm Description
Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The control group will receive a similar volume load of normal saline and maintenance doses.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Cyklokapron, Transamin
Intervention Description
10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The control group will receive a similar volume load of normal saline and maintenance doses.
Primary Outcome Measure Information:
Title
Intra-operative Blood Loss
Time Frame
Day of Surgery
Secondary Outcome Measure Information:
Title
Number of Participants That Required an Allogenic Transfusion
Time Frame
Perioperative (hospitalized period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (18 years of age or greater) with acetabulum fractures and/or pelvic ring injuries that require operative fixation via an open surgical approach Exclusion Criteria: Revision surgery Surgery occurring more than 2 weeks post-injury History of blood dyscrasia or renal insufficiency History of any thromboembolic disease Pregnancy or nursing, color vision defects History of retinal detachment/degeneration Intracranial hemorrhage Hypersensitivity to tranexamic acid Contraceptive Use (estrogens/progestins) FEIBA (anti-inhibitor coagulant complex) use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett D Crist, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid

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