Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid

Acetabulum Fractures Clinical Trial

— TXA  

Official title:

Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid: A Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051686
• Other study ID #: 1208444
• Status: Completed
• Phase: N/A
• First received: January 29, 2014
• Last updated: January 30, 2018
• Start date: June 2013
• Est. completion date: December 2016

Study information

• Verified date: January 2018
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acetabulum Fractures

Intervention

Drug:
• Tranexamic Acid
10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.
• Placebo
The control group will receive a similar volume load of normal saline and maintenance doses.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-operative Blood Loss		Day of Surgery
Secondary	Number of Participants That Required an Allogenic Transfusion		Perioperative (hospitalized period)